{
  "id": "betapace-sotalol",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-09-02",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "BETAPACE / BETAPACE AF",
    "generic": "盐酸索他洛尔片",
    "aliases": [
      "BETAPACE",
      "Betapace",
      "BETAPACE AF",
      "Betapace AF",
      "sotalol",
      "sotalol hydrochloride",
      "索他洛尔",
      "盐酸索他洛尔",
      "盐酸索他洛尔片",
      "sotalol tablets",
      "NDA 019865",
      "NDA 021151",
      "83107-005-10",
      "83107-006-10",
      "83107-007-10",
      "83107-008-60",
      "83107-009-60",
      "83107-010-60",
      "BETAPACE 80 MG",
      "BETAPACE 120 MG",
      "BETAPACE 160 MG",
      "BHCP 80 MG",
      "BHCP 120 MG",
      "BHCP 160 MG"
    ],
    "marketBrandNames": [
      {
        "name": "BETAPACE",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "evidenceStatus": "current_regulatory_record",
        "note": {
          "zh": "NDA 019865 原研/RLD；当前标签展示浅蓝色 80／120／160 mg、各 100 片瓶装。Orange Book 另有 240 mg 活跃条目，但当前准确包装页面未展示，本站不补造包装。",
          "en": "Originator/RLD under NDA 019865. The current label displays light-blue 80, 120 and 160 mg tablets in 100-tablet bottles. The Orange Book also lists an active 240 mg row, but the current exact-package page does not display it, so this site does not invent a pack."
        },
        "source": {
          "id": "src_2133e5eac8c74c36",
          "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        }
      },
      {
        "name": "BETAPACE AF",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "evidenceStatus": "current_regulatory_record",
        "note": {
          "zh": "独立 NDA 021151；当前标签展示白色 80／120／160 mg、各 60 片患者包装。与 BETAPACE 共同成分不等于可以自行替换。",
          "en": "Separate NDA 021151. The current label displays white 80, 120 and 160 mg tablets in 60-tablet patient packs. A shared ingredient with BETAPACE does not permit self-substitution."
        },
        "source": {
          "id": "src_2133e5eac8c74c36",
          "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        }
      }
    ],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "心血管",
    "sourceArchiveMarket": "FDA Orange Book 第 46 版把 BETAPACE NDA 019865 的 80／120／160／240 mg 列为活跃口服片，其中 160 mg 标为 RLD/RS；BETAPACE AF NDA 021151 的 80／120／160 mg 列为活跃口服片，其中 160 mg 标为 RLD/RS。当前 DailyMed 准确包装仅展示两个品牌系列各 80／120／160 mg，共六个瓶装。本页不把 Orange Book 其他规格推写为当前可见包装，也不把监管条目写成实时库存。",
    "dosageFormClass": "BETAPACE 与 BETAPACE AF 都含盐酸索他洛尔，但属于不同 NDA、适应证标签与患者包装路径；SOTYLIZE 口服液、静脉注射剂、其他品牌或仿制品也是不同准确产品。共同成分或相同 mg 不建立自行换算、轮换、叠加、补服、分片或替换结论。",
    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "1992（BETAPACE 美国首次批准）",
    "archiveSponsorText": "Legacy Pharma（当前 BETAPACE／BETAPACE AF 标签方）；BETAPACE 为 NDA 019865 原研/RLD"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [
      "BETAPACE",
      "BETAPACE AF",
      "sotalol",
      "sotalol hydrochloride",
      "索他洛尔",
      "盐酸索他洛尔",
      "盐酸索他洛尔片"
    ],
    "excludedProductCues": [
      "SOTYLIZE",
      "sotalol oral solution",
      "sotalol injection",
      "intravenous sotalol",
      "索他洛尔口服液",
      "索他洛尔注射液",
      "SORINE"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-betapace-sotalol-80mg-100-tablet-bottle-ndc-8310700510",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国原品牌标签（2024-12-16 更新；Rev. 8/24）",
        "en": "Current U.S. originator-brand DailyMed label (updated 16 Dec 2024; Rev. 8/24)"
      },
      "dosageForm": {
        "zh": "BETAPACE 盐酸索他洛尔刻痕口服片",
        "en": "BETAPACE scored sotalol hydrochloride oral tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 83107-005-10",
      "pouchCode": null,
      "applicationNumber": "NDA 019865",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片盐酸索他洛尔 80 mg；100 片瓶装",
        "en": "80 mg sotalol hydrochloride per tablet; 100-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=betapace-tabs-80mg-100s-bottle-label.jpg&setid=a6a7702f-36c9-45db-b640-453dc324baee",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸索他洛尔",
            "en": "sotalol hydrochloride"
          },
          "value": 80,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、频次、补服、分片指令，也不是 BETAPACE 与 BETAPACE AF、SOTYLIZE 口服液、静脉注射剂或其他抗心律失常药的换算值",
            "en": "labelled amount per tablet; not an individual's tablet count, frequency, catch-up or splitting instruction, and not a conversion between BETAPACE and BETAPACE AF, SOTYLIZE oral solution, intravenous sotalol or another antiarrhythmic"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-02",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_live_stock",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 100,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅蓝色",
          "en": "light blue"
        },
        "shape": {
          "zh": "胶囊形／椭圆形刻痕片",
          "en": "capsule-shaped or oval scored tablet"
        },
        "imprint": "BETAPACE;80;MG",
        "scoreStatus": "scored_appearance_clue_not_self_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_2133e5eac8c74c36",
        "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-02",
        "reviewedAt": "2026-09-02"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-betapace-sotalol-120mg-100-tablet-bottle-ndc-8310700610",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国原品牌标签（2024-12-16 更新；Rev. 8/24）",
        "en": "Current U.S. originator-brand DailyMed label (updated 16 Dec 2024; Rev. 8/24)"
      },
      "dosageForm": {
        "zh": "BETAPACE 盐酸索他洛尔刻痕口服片",
        "en": "BETAPACE scored sotalol hydrochloride oral tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 83107-006-10",
      "pouchCode": null,
      "applicationNumber": "NDA 019865",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片盐酸索他洛尔 120 mg；100 片瓶装",
        "en": "120 mg sotalol hydrochloride per tablet; 100-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=betapace-tabs-120mg-100s-bottle-label.jpg&setid=a6a7702f-36c9-45db-b640-453dc324baee",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸索他洛尔",
            "en": "sotalol hydrochloride"
          },
          "value": 120,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、频次、补服、分片指令，也不是 BETAPACE 与 BETAPACE AF、SOTYLIZE 口服液、静脉注射剂或其他抗心律失常药的换算值",
            "en": "labelled amount per tablet; not an individual's tablet count, frequency, catch-up or splitting instruction, and not a conversion between BETAPACE and BETAPACE AF, SOTYLIZE oral solution, intravenous sotalol or another antiarrhythmic"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-02",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_live_stock",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 100,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅蓝色",
          "en": "light blue"
        },
        "shape": {
          "zh": "胶囊形／椭圆形刻痕片",
          "en": "capsule-shaped or oval scored tablet"
        },
        "imprint": "BETAPACE;120;MG",
        "scoreStatus": "scored_appearance_clue_not_self_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_2133e5eac8c74c36",
        "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-02",
        "reviewedAt": "2026-09-02"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-betapace-sotalol-160mg-100-tablet-bottle-ndc-8310700710",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国原品牌标签（2024-12-16 更新；Rev. 8/24）",
        "en": "Current U.S. originator-brand DailyMed label (updated 16 Dec 2024; Rev. 8/24)"
      },
      "dosageForm": {
        "zh": "BETAPACE 盐酸索他洛尔刻痕口服片",
        "en": "BETAPACE scored sotalol hydrochloride oral tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 83107-007-10",
      "pouchCode": null,
      "applicationNumber": "NDA 019865",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片盐酸索他洛尔 160 mg；100 片瓶装",
        "en": "160 mg sotalol hydrochloride per tablet; 100-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=betapace-tabs-160mg-100s-bottle-label.jpg&setid=a6a7702f-36c9-45db-b640-453dc324baee",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸索他洛尔",
            "en": "sotalol hydrochloride"
          },
          "value": 160,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、频次、补服、分片指令，也不是 BETAPACE 与 BETAPACE AF、SOTYLIZE 口服液、静脉注射剂或其他抗心律失常药的换算值",
            "en": "labelled amount per tablet; not an individual's tablet count, frequency, catch-up or splitting instruction, and not a conversion between BETAPACE and BETAPACE AF, SOTYLIZE oral solution, intravenous sotalol or another antiarrhythmic"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-02",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_live_stock",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 100,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅蓝色",
          "en": "light blue"
        },
        "shape": {
          "zh": "胶囊形／椭圆形刻痕片",
          "en": "capsule-shaped or oval scored tablet"
        },
        "imprint": "BETAPACE;160;MG",
        "scoreStatus": "scored_appearance_clue_not_self_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_2133e5eac8c74c36",
        "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-02",
        "reviewedAt": "2026-09-02"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-betapace-af-sotalol-80mg-60-tablet-bottle-ndc-8310700860",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国原品牌标签（2024-12-16 更新；Rev. 8/24）",
        "en": "Current U.S. originator-brand DailyMed label (updated 16 Dec 2024; Rev. 8/24)"
      },
      "dosageForm": {
        "zh": "BETAPACE AF 盐酸索他洛尔刻痕口服片",
        "en": "BETAPACE AF scored sotalol hydrochloride oral tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 83107-008-60",
      "pouchCode": null,
      "applicationNumber": "NDA 021151",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片盐酸索他洛尔 80 mg；60 片瓶装",
        "en": "80 mg sotalol hydrochloride per tablet; 60-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=betapace-af-tabs-80mg-60s-bottle-label.jpg&setid=a6a7702f-36c9-45db-b640-453dc324baee",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸索他洛尔",
            "en": "sotalol hydrochloride"
          },
          "value": 80,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、频次、补服、分片指令，也不是 BETAPACE 与 BETAPACE AF、SOTYLIZE 口服液、静脉注射剂或其他抗心律失常药的换算值",
            "en": "labelled amount per tablet; not an individual's tablet count, frequency, catch-up or splitting instruction, and not a conversion between BETAPACE and BETAPACE AF, SOTYLIZE oral solution, intravenous sotalol or another antiarrhythmic"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 60,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-02",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_live_stock",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 60,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "白色",
          "en": "white"
        },
        "shape": {
          "zh": "胶囊形／椭圆形刻痕片",
          "en": "capsule-shaped or oval scored tablet"
        },
        "imprint": "BHCP;80;MG",
        "scoreStatus": "scored_appearance_clue_not_self_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_2133e5eac8c74c36",
        "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-02",
        "reviewedAt": "2026-09-02"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-betapace-af-sotalol-120mg-60-tablet-bottle-ndc-8310700960",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国原品牌标签（2024-12-16 更新；Rev. 8/24）",
        "en": "Current U.S. originator-brand DailyMed label (updated 16 Dec 2024; Rev. 8/24)"
      },
      "dosageForm": {
        "zh": "BETAPACE AF 盐酸索他洛尔刻痕口服片",
        "en": "BETAPACE AF scored sotalol hydrochloride oral tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 83107-009-60",
      "pouchCode": null,
      "applicationNumber": "NDA 021151",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片盐酸索他洛尔 120 mg；60 片瓶装",
        "en": "120 mg sotalol hydrochloride per tablet; 60-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=betapace-af-tabs-120mg-60s-bottle-label.jpg&setid=a6a7702f-36c9-45db-b640-453dc324baee",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸索他洛尔",
            "en": "sotalol hydrochloride"
          },
          "value": 120,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、频次、补服、分片指令，也不是 BETAPACE 与 BETAPACE AF、SOTYLIZE 口服液、静脉注射剂或其他抗心律失常药的换算值",
            "en": "labelled amount per tablet; not an individual's tablet count, frequency, catch-up or splitting instruction, and not a conversion between BETAPACE and BETAPACE AF, SOTYLIZE oral solution, intravenous sotalol or another antiarrhythmic"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 60,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-02",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_live_stock",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 60,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "白色",
          "en": "white"
        },
        "shape": {
          "zh": "胶囊形／椭圆形刻痕片",
          "en": "capsule-shaped or oval scored tablet"
        },
        "imprint": "BHCP;120;MG",
        "scoreStatus": "scored_appearance_clue_not_self_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_2133e5eac8c74c36",
        "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-02",
        "reviewedAt": "2026-09-02"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-betapace-af-sotalol-160mg-60-tablet-bottle-ndc-8310701060",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国原品牌标签（2024-12-16 更新；Rev. 8/24）",
        "en": "Current U.S. originator-brand DailyMed label (updated 16 Dec 2024; Rev. 8/24)"
      },
      "dosageForm": {
        "zh": "BETAPACE AF 盐酸索他洛尔刻痕口服片",
        "en": "BETAPACE AF scored sotalol hydrochloride oral tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 83107-010-60",
      "pouchCode": null,
      "applicationNumber": "NDA 021151",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片盐酸索他洛尔 160 mg；60 片瓶装",
        "en": "160 mg sotalol hydrochloride per tablet; 60-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=betapace-af-tabs-160mg-60s-bottle-label.jpg&setid=a6a7702f-36c9-45db-b640-453dc324baee",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸索他洛尔",
            "en": "sotalol hydrochloride"
          },
          "value": 160,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、频次、补服、分片指令，也不是 BETAPACE 与 BETAPACE AF、SOTYLIZE 口服液、静脉注射剂或其他抗心律失常药的换算值",
            "en": "labelled amount per tablet; not an individual's tablet count, frequency, catch-up or splitting instruction, and not a conversion between BETAPACE and BETAPACE AF, SOTYLIZE oral solution, intravenous sotalol or another antiarrhythmic"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 60,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-02",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_live_stock",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 60,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "白色",
          "en": "white"
        },
        "shape": {
          "zh": "胶囊形／椭圆形刻痕片",
          "en": "capsule-shaped or oval scored tablet"
        },
        "imprint": "BHCP;160;MG",
        "scoreStatus": "scored_appearance_clue_not_self_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_2133e5eac8c74c36",
        "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-02",
        "reviewedAt": "2026-09-02"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "presentationId": "us-betapace-sotalol-80mg-100-tablet-bottle-ndc-8310700510",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=betapace-tabs-80mg-100s-bottle-label.jpg&setid=a6a7702f-36c9-45db-b640-453dc324baee",
    "alt": "Legacy Pharma BETAPACE 盐酸索他洛尔 80 mg、NDC 83107-005-10、100 片瓶装的 DailyMed 官方原品牌标签面板",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed 当前美国原品牌标签（2024-12 更新）",
    "presentation": "BETAPACE 80 mg：浅蓝色胶囊形刻痕片，印有 BETAPACE／80 MG；NDC 83107-005-10，100 片瓶装。",
    "notice": "此图只对应 BETAPACE 80 mg、NDC 83107-005-10。BETAPACE AF 为白色患者包装；其他规格、口服液、注射剂、仿制品或其他市场不能从此图外推。本图不用于鉴定真伪。",
    "source": {
      "id": "src_2133e5eac8c74c36",
      "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-02",
      "reviewedAt": "2026-09-02"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "BETAPACE／索他洛尔说明书放大阅读：先看黑框警告、QT、肾功能与准确品牌系列",
      "en": "BETAPACE / sotalol enlarged label: boxed warning, QT, kidney function and exact brand family first"
    },
    "summary": {
      "zh": "80／120／160 mg 是每片含量；BETAPACE 的 100 Tablets 和 BETAPACE AF 的 60 tablets 是整瓶片数。两个系列均有刻痕，但刻痕只属于准确产品的外观与标签线索，不自动构成自行掰片、减量或换药许可。",
      "en": "The 80, 120 and 160 mg figures are amounts per tablet. BETAPACE 100 Tablets and BETAPACE AF 60 tablets are bottle counts. Both families are scored, but a score is an exact-product appearance and label clue, not automatic permission to split, reduce or switch."
    },
    "checks": [
      {
        "zh": "黑框警告指出索他洛尔可因 QT 延长引起危及生命的室性心动过速；开始或重新开始用药需要可连续心电监护和心脏复苏的医疗环境，并按肌酐清除率调整给药间隔。网页不能把这些专业监护要求变成家庭加减量表。",
        "en": "The boxed warning states that sotalol can cause life-threatening ventricular tachycardia associated with QT prolongation. Initiation or reinitiation requires a facility with continuous ECG monitoring and cardiac resuscitation, with dosing interval based on creatinine clearance. The site cannot turn these professional monitoring requirements into a home adjustment table."
      },
      {
        "zh": "低心率（心动过缓）、房室传导阻滞、低血压、心衰、头晕或晕厥可能增加跌倒和急性风险。严重晕厥、心悸伴不适、胸痛、呼吸困难、抽搐或意识异常应使用当地急救；不要等待网页判断。",
        "en": "Bradycardia, atrioventricular block, hypotension, heart failure, dizziness or syncope can increase fall and acute risk. Severe fainting, symptomatic palpitations, chest pain, breathing difficulty, seizure or altered awareness needs local emergency care; do not wait for a webpage to decide."
      },
      {
        "zh": "严重腹泻、呕吐、异常出汗、食欲明显下降或过度口渴可能改变钾镁等电解质并影响致心律失常风险。老人、肾功能变化或同时用利尿剂者应及时让临床团队核对，而不是自行补钾、补镁、停药或补服。",
        "en": "Severe diarrhoea, vomiting, unusual sweating, markedly reduced appetite or excessive thirst can change electrolytes such as potassium and magnesium and affect proarrhythmic risk. Older adults, changing kidney function or co-use of a diuretic needs timely clinical review, not self-supplementation, stopping or catch-up dosing."
      },
      {
        "zh": "标签要求避免与 I 类或 III 类抗心律失常药及其他延长 QT 的药自行合用；地高辛、维拉帕米／地尔硫䓬、其他 β 阻滞剂或可乐定可能进一步影响心率、血压或心功能。看到共同药名时，不要自行错开、轮换或先停其中一种。",
        "en": "The label says to avoid self-co-use with Class I or III antiarrhythmics and other QT-prolonging medicines. Digoxin, verapamil/diltiazem, another beta blocker or clonidine can further affect heart rate, pressure or cardiac function. Do not self-space, alternate or choose one to stop when these names appear together."
      },
      {
        "zh": "含氧化铝或氢氧化镁的抗酸药可降低索他洛尔暴露；标签给出专属时间边界，但网页不根据一个成分名自动生成个人错开时间。请让药师核对实际抗酸药、处方、肾功能和全部药单。",
        "en": "Antacids containing aluminium oxide or magnesium hydroxide can reduce sotalol exposure. The label provides a product-specific timing boundary, but the site does not auto-generate an individual separation schedule from an ingredient name. Have the actual antacid, prescription, kidney function and full list reviewed."
      },
      {
        "zh": "说明书明确漏服后不要用下一次加倍补偿；本页只呈现这一标签警示，不计算任何人的下一次时间。索他洛尔属于高风险抗心律失常药，漏服、停药或供应中断应及时联系开方团队。",
        "en": "The label explicitly says not to double the next dose to compensate for a missed dose. This page presents that warning but calculates no individual's next time. Sotalol is a higher-risk antiarrhythmic; missed doses, interruption or supply gaps need prompt contact with the prescribing team."
      }
    ],
    "source": {
      "id": "src_2133e5eac8c74c36",
      "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-02",
      "reviewedAt": "2026-09-02"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "索他洛尔怎样起作用：同时具有 β 受体阻滞与延长心肌动作电位的作用",
      "en": "How sotalol works: beta blockade together with cardiac action-potential prolongation"
    },
    "summary": {
      "zh": "标签将索他洛尔描述为兼具 Vaughan Williams II 类 β 受体阻滞和 III 类延长心肌动作电位作用的抗心律失常药。这有助理解为什么心率、QT、电解质、肾功能和其他药必须一起看，但不能从机制决定个人能否使用或怎样调整。",
      "en": "The label describes sotalol as an antiarrhythmic with both Vaughan Williams Class II beta-blocking and Class III cardiac action-potential-prolonging properties. This helps explain why heart rate, QT, electrolytes, kidney function and other medicines must be reviewed together, but mechanism cannot decide individual suitability or adjustment."
    },
    "checks": [
      {
        "zh": "它具有 β 阻滞作用，不代表可与美托洛尔、比索洛尔、阿替洛尔、普萘洛尔、卡维地洛或奈必洛尔按 mg 换算、叠加或轮换。",
        "en": "Its beta-blocking action does not permit milligram conversion, combination or alternation with metoprolol, bisoprolol, atenolol, propranolol, carvedilol or nebivolol."
      },
      {
        "zh": "它也具有延长动作电位／QT 的作用，不代表可与胺碘酮、氟卡尼、普罗帕酮或其他抗心律失常药自行比较强弱、组合或替换。",
        "en": "Its action-potential/QT effect likewise does not permit self-comparison, combination or substitution with amiodarone, flecainide, propafenone or another antiarrhythmic."
      },
      {
        "zh": "索他洛尔主要经肾脏清除，说明书要求按肾功能安排专业给药间隔。作用机制、一次心率或一个肌酐值都不能由网页转换成个人片数或频次。",
        "en": "Sotalol is cleared mainly by the kidneys, and the label requires professional dosing-interval decisions based on renal function. Mechanism, one heart-rate reading or one creatinine value cannot be converted by the site into an individual's tablet count or frequency."
      }
    ],
    "source": {
      "id": "src_2133e5eac8c74c36",
      "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-02",
      "reviewedAt": "2026-09-02"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "BETAPACE / BETAPACE AF",
      "generic": "盐酸索他洛尔片",
      "dosageFormClass": "BETAPACE 与 BETAPACE AF 都含盐酸索他洛尔，但属于不同 NDA、适应证标签与患者包装路径；SOTYLIZE 口服液、静脉注射剂、其他品牌或仿制品也是不同准确产品。共同成分或相同 mg 不建立自行换算、轮换、叠加、补服、分片或替换结论。"
    },
    "labelSource": {
      "id": "src_2133e5eac8c74c36",
      "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-02",
      "reviewedAt": "2026-09-02"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_2133e5eac8c74c36",
          "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "美国国家医学图书馆 DailyMed",
          "en": "U.S. National Library of Medicine DailyMed"
        },
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "recordType": {
          "zh": "公开药品标签",
          "en": "Public medicine label"
        },
        "reviewedAt": "2026-09-02",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      },
      {
        "source": {
          "id": "src_cf19c076f73ee17a",
          "label": "FDA：BETAPACE／BETAPACE AF 盐酸索他洛尔处方标签（NDA 019865／021151；2021-06 版本）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019865s022lbl.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_regulatory_document",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "FDA",
          "en": "FDA"
        },
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "recordType": {
          "zh": "监管产品记录或标签档案",
          "en": "Regulatory product record or label archive"
        },
        "reviewedAt": "2026-09-02",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      },
      {
        "source": {
          "id": "src_3d17358ce65b1cf8",
          "label": "FDA Orange Book 第 46 版（2026）：BETAPACE／BETAPACE AF 盐酸索他洛尔口服片的 RLD、RS、规格、NDA 与批准日期",
          "url": "https://www.fda.gov/media/71474/download",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "FDA",
          "en": "FDA"
        },
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "recordType": {
          "zh": "监管产品记录或标签档案",
          "en": "Regulatory product record or label archive"
        },
        "reviewedAt": "2026-09-02",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      },
      {
        "source": {
          "id": "src_25b00eef6caf395b",
          "label": "FDA Orange Book 2026 年 6 月累计增补：BETAPACE NDA 019865 活跃／停市行状态变更记录",
          "url": "https://www.fda.gov/media/72973/download",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "FDA",
          "en": "FDA"
        },
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "recordType": {
          "zh": "监管产品记录或标签档案",
          "en": "Regulatory product record or label archive"
        },
        "reviewedAt": "2026-09-02",
        "scope": {
          "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
          "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
        }
      }
    ],
    "recordRoute": {
      "status": "product_level_public_record_verified",
      "authority": {
        "zh": "美国国家医学图书馆 DailyMed",
        "en": "U.S. National Library of Medicine DailyMed"
      },
      "market": {
        "zh": "美国",
        "en": "United States"
      },
      "recordType": {
        "zh": "公开药品标签",
        "en": "Public medicine label"
      },
      "reviewedAt": "2026-09-02",
      "scope": {
        "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。",
        "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk."
      }
    },
    "channels": [
      {
        "id": "china-nmpa-drug-evaluation-centre",
        "authority": "NMPA 药品评价中心",
        "market": {
          "zh": "中国大陆",
          "en": "Mainland China"
        },
        "title": {
          "zh": "药物警戒快讯与安全警示",
          "en": "Drug-vigilance bulletins and safety notices"
        },
        "purpose": {
          "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。",
          "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item."
        },
        "source": {
          "id": "src_05ff2860226564d4",
          "label": "国家药监局药品评价中心：药物警戒与安全警示入口",
          "url": "https://www.cdr-adr.org.cn/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "CN",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "fda-drug-safety-communications",
        "authority": "FDA",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "title": {
          "zh": "药物安全通讯",
          "en": "Drug Safety Communications"
        },
        "purpose": {
          "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。",
          "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications."
        },
        "source": {
          "id": "src_9177df9e1825aa72",
          "label": "FDA：Drug Safety Communications",
          "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "fda-medwatch",
        "authority": "FDA MedWatch",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "title": {
          "zh": "安全信息与严重问题报告",
          "en": "Safety information and serious-problem reporting"
        },
        "purpose": {
          "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。",
          "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality."
        },
        "source": {
          "id": "src_e4739cd55d27ab51",
          "label": "FDA：MedWatch 药品安全信息与不良事件报告计划",
          "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "adverse_event_reporting",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "ema-pharmacovigilance",
        "authority": "EMA",
        "market": {
          "zh": "欧盟/欧洲经济区",
          "en": "European Union / European Economic Area"
        },
        "title": {
          "zh": "药物警戒概览与 EudraVigilance",
          "en": "Pharmacovigilance overview and EudraVigilance"
        },
        "purpose": {
          "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。",
          "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment."
        },
        "source": {
          "id": "src_2ad42a3deae747d1",
          "label": "EMA：Pharmacovigilance overview",
          "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "EU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "javascript_or_cookie_controls",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "mhra-drug-safety-update",
        "authority": "MHRA",
        "market": {
          "zh": "英国",
          "en": "United Kingdom"
        },
        "title": {
          "zh": "Drug Safety Update",
          "en": "Drug Safety Update"
        },
        "purpose": {
          "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。",
          "en": "Primary UK MHRA medicine-safety updates for professionals and the public."
        },
        "source": {
          "id": "src_23fdbe67abeafc63",
          "label": "MHRA：Drug Safety Update",
          "url": "https://www.gov.uk/drug-safety-update",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "UK",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "pmda-drug-safety",
        "authority": "PMDA",
        "market": {
          "zh": "日本",
          "en": "Japan"
        },
        "title": {
          "zh": "药品安全信息",
          "en": "Medicine safety information"
        },
        "purpose": {
          "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。",
          "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents."
        },
        "source": {
          "id": "src_06d6be2880f12024",
          "label": "PMDA：Safety Information Regarding Drugs",
          "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "JP",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "mfds-drug-safety-letters",
        "authority": "MFDS",
        "market": {
          "zh": "韩国",
          "en": "Republic of Korea"
        },
        "title": {
          "zh": "药品安全性书信",
          "en": "Medicine safety letters"
        },
        "purpose": {
          "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。",
          "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case."
        },
        "source": {
          "id": "src_2d7f5018cd05eff4",
          "label": "MFDS：药品安全性书信（韩文原始资料）",
          "url": "https://www.mfds.go.kr/brd/m_545/list.do",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "KR",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "hsa-adverse-events",
        "authority": "HSA",
        "market": {
          "zh": "新加坡",
          "en": "Singapore"
        },
        "title": {
          "zh": "不良反应报告与药物安全信息",
          "en": "Adverse-event reporting and medicine-safety information"
        },
        "purpose": {
          "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。",
          "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information."
        },
        "source": {
          "id": "src_9240397d5a8574c1",
          "label": "HSA：Report adverse events",
          "url": "https://www.hsa.gov.sg/adverse-events/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "adverse_event_reporting",
          "market": "SG",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "health-canada-medeffect-advisories",
        "authority": "Health Canada",
        "market": {
          "zh": "加拿大",
          "en": "Canada"
        },
        "title": {
          "zh": "MedEffect 加拿大：建议、警告与召回",
          "en": "MedEffect Canada: advisories, warnings and recalls"
        },
        "purpose": {
          "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。",
          "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item."
        },
        "source": {
          "id": "src_212ec921fa6634ad",
          "label": "Health Canada：MedEffect Canada 建议、警告与召回",
          "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "CA",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "tga-safety-alerts",
        "authority": "TGA",
        "market": {
          "zh": "澳大利亚",
          "en": "Australia"
        },
        "title": {
          "zh": "药品安全警示",
          "en": "Medicine safety alerts"
        },
        "purpose": {
          "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。",
          "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products."
        },
        "source": {
          "id": "src_ffe6142814f88fac",
          "label": "TGA：Safety alerts",
          "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "AU",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "swissmedic-pharmacovigilance",
        "authority": "Swissmedic",
        "market": {
          "zh": "瑞士",
          "en": "Switzerland"
        },
        "title": {
          "zh": "药物警戒与不良反应报告",
          "en": "Pharmacovigilance and suspected adverse-reaction reporting"
        },
        "purpose": {
          "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。",
          "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality."
        },
        "source": {
          "id": "src_c854f813ce2671df",
          "label": "Swissmedic：Pharmacovigilance",
          "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "adverse_event_reporting",
          "market": "CH",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "medsafe-safety-communications",
        "authority": "Medsafe",
        "market": {
          "zh": "新西兰",
          "en": "New Zealand"
        },
        "title": {
          "zh": "药品安全通讯",
          "en": "Medicine safety communications"
        },
        "purpose": {
          "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。",
          "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information."
        },
        "source": {
          "id": "src_3510c1a523ec9769",
          "label": "Medsafe：Safety Communications",
          "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "NZ",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "sahpra-safety-information",
        "authority": "SAHPRA",
        "market": {
          "zh": "南非",
          "en": "South Africa"
        },
        "title": {
          "zh": "药物安全信息、警示与药物警戒",
          "en": "Medicine safety information, alerts and pharmacovigilance"
        },
        "purpose": {
          "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。",
          "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information."
        },
        "source": {
          "id": "src_25b0aaefee742163",
          "label": "SAHPRA：Safety Information Updates / Pharmacovigilance",
          "url": "https://www.sahpra.org.za/safety-information-and-updates/",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "ZA",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "who-medicine-safety-alerts",
        "authority": "WHO",
        "market": {
          "zh": "全球",
          "en": "Global"
        },
        "title": {
          "zh": "药品与疫苗安全警示档案",
          "en": "Medicine and vaccine safety-alert archive"
        },
        "purpose": {
          "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。",
          "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market."
        },
        "source": {
          "id": "src_9a7dc56ec34c7e1a",
          "label": "WHO：Safety alerts for medicines and vaccines",
          "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "GLOBAL",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      },
      {
        "id": "anvisa-pharmacovigilance",
        "authority": "Anvisa",
        "market": {
          "zh": "巴西",
          "en": "Brazil"
        },
        "title": {
          "zh": "药物警戒、警示与 VigiMed",
          "en": "Pharmacovigilance, alerts and VigiMed"
        },
        "purpose": {
          "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。",
          "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item."
        },
        "source": {
          "id": "src_5de362c12580111d",
          "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）",
          "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "official_safety_monitoring",
          "documentKind": "regulatory_safety_communication",
          "market": "BR",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-22",
          "reviewedAt": "2026-08-22"
        }
      }
    ],
    "notices": [],
    "boundary": {
      "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。",
      "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline."
    },
    "scope": "official_routes_only_no_live_alert_inference"
  },
  "archive": {
    "summary": "BETAPACE／BETAPACE AF 是盐酸索他洛尔原品牌口服片。80／120／160 mg 是每片含量；BETAPACE 的 100 Tablets 与 BETAPACE AF 的 60 tablets 是整瓶片数。说明书有危及生命的致心律失常黑框警告，强调 QT、心电监护、肾功能和电解质；低心率、晕厥、心衰、腹泻呕吐、跌倒以及与其他延长 QT、减慢心率或降压药同处药单时都需优先核对。网页不生成个人剂量、频次、补服、错开、停药或换药方案。",
    "history": "BETAPACE 于 1992 年在美国获批用于危及生命的室性心律失常。BETAPACE AF 后以独立 NDA 用于有症状房颤／房扑患者维持窦性心律。当前两个品牌系列同页呈现，但监管身份、包装颜色、瓶装数量与标签用途仍须分别阅读；它们不能被共同通用名自动合并。",
    "sourceDocuments": [
      {
        "id": "src_2133e5eac8c74c36",
        "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-02",
        "reviewedAt": "2026-09-02"
      },
      {
        "id": "src_cf19c076f73ee17a",
        "label": "FDA：BETAPACE／BETAPACE AF 盐酸索他洛尔处方标签（NDA 019865／021151；2021-06 版本）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019865s022lbl.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_regulatory_document",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-02",
        "reviewedAt": "2026-09-02"
      },
      {
        "id": "src_3d17358ce65b1cf8",
        "label": "FDA Orange Book 第 46 版（2026）：BETAPACE／BETAPACE AF 盐酸索他洛尔口服片的 RLD、RS、规格、NDA 与批准日期",
        "url": "https://www.fda.gov/media/71474/download",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "regulatory_product_record",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-02",
        "reviewedAt": "2026-09-02"
      },
      {
        "id": "src_25b00eef6caf395b",
        "label": "FDA Orange Book 2026 年 6 月累计增补：BETAPACE NDA 019865 活跃／停市行状态变更记录",
        "url": "https://www.fda.gov/media/72973/download",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "regulatory_product_record",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-02",
        "reviewedAt": "2026-09-02"
      }
    ],
    "applicationNumber": "BETAPACE NDA 019865；BETAPACE AF NDA 021151",
    "approvalTimeline": [
      {
        "date": "1992-10-30",
        "title": {
          "zh": "BETAPACE 在美国首次获批",
          "en": "Initial U.S. approval of BETAPACE"
        },
        "detail": {
          "zh": "FDA Orange Book 记录 NDA 019865 的 BETAPACE 于 1992 年获批，并保留为原研/RLD 监管身份。",
          "en": "The FDA Orange Book records 1992 approval of BETAPACE under NDA 019865 and retains its originator/RLD regulatory identity."
        },
        "source": {
          "id": "src_3d17358ce65b1cf8",
          "label": "FDA Orange Book 第 46 版（2026）：BETAPACE／BETAPACE AF 盐酸索他洛尔口服片的 RLD、RS、规格、NDA 与批准日期",
          "url": "https://www.fda.gov/media/71474/download",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        }
      },
      {
        "date": "2000-02-22",
        "title": {
          "zh": "BETAPACE AF 80／120／160 mg 获批",
          "en": "Approval of BETAPACE AF 80/120/160 mg"
        },
        "detail": {
          "zh": "BETAPACE AF 通过独立 NDA 021151 建立房颤／房扑相关标签与患者包装路径。",
          "en": "BETAPACE AF established its AFIB/AFL labelling and patient-pack route under separate NDA 021151."
        },
        "source": {
          "id": "src_3d17358ce65b1cf8",
          "label": "FDA Orange Book 第 46 版（2026）：BETAPACE／BETAPACE AF 盐酸索他洛尔口服片的 RLD、RS、规格、NDA 与批准日期",
          "url": "https://www.fda.gov/media/71474/download",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        }
      },
      {
        "date": "2024-12-16",
        "title": {
          "zh": "Legacy Pharma 当前原品牌标签更新",
          "en": "Current Legacy Pharma originator-brand label updated"
        },
        "detail": {
          "zh": "当前 DailyMed 页面列出 BETAPACE 与 BETAPACE AF 各三个规格、共六个准确包装面板。",
          "en": "The current DailyMed page lists three strengths for each of BETAPACE and BETAPACE AF, with six exact package panels in total."
        },
        "source": {
          "id": "src_2133e5eac8c74c36",
          "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        }
      },
      {
        "date": "2026-06",
        "title": {
          "zh": "Orange Book 累计增补记录 BETAPACE 状态更新",
          "en": "Orange Book cumulative supplement recorded BETAPACE status updates"
        },
        "detail": {
          "zh": "该增补用于核对监管列表变化；它不等于实时库存、处方变化或个体替换许可。",
          "en": "The supplement supports regulatory-list reconciliation; it is not live inventory, a prescription change or individual substitution permission."
        },
        "source": {
          "id": "src_25b00eef6caf395b",
          "label": "FDA Orange Book 2026 年 6 月累计增补：BETAPACE NDA 019865 活跃／停市行状态变更记录",
          "url": "https://www.fda.gov/media/72973/download",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-02",
          "reviewedAt": "2026-09-02"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "美国 BETAPACE",
          "en": "United States — BETAPACE"
        },
        "status": {
          "zh": "当前原品牌口服片标签",
          "en": "Current originator-brand oral-tablet label"
        },
        "detail": {
          "zh": "NDA 019865；当前准确包装显示 80／120／160 mg，各 100 片瓶装。",
          "en": "NDA 019865; current exact packs show 80, 120 and 160 mg in 100-tablet bottles."
        }
      },
      {
        "market": {
          "zh": "美国 BETAPACE AF",
          "en": "United States — BETAPACE AF"
        },
        "status": {
          "zh": "当前独立 NDA 患者包装",
          "en": "Current separate-NDA patient pack"
        },
        "detail": {
          "zh": "NDA 021151；当前准确包装显示 80／120／160 mg，各 60 片瓶装。",
          "en": "NDA 021151; current exact packs show 80, 120 and 160 mg in 60-tablet bottles."
        }
      },
      {
        "market": {
          "zh": "口服液、静脉注射剂及其他品牌",
          "en": "Oral solution, intravenous product and other brands"
        },
        "status": {
          "zh": "不同准确产品",
          "en": "Separate exact products"
        },
        "detail": {
          "zh": "SOTYLIZE、静脉索他洛尔、SORINE 与仿制品不并入六个原品牌包装，也不建立换算。",
          "en": "SOTYLIZE, intravenous sotalol, SORINE and generics are not merged into the six originator-brand packs and no conversion is established."
        }
      },
      {
        "market": {
          "zh": "美国以外市场",
          "en": "Markets outside the United States"
        },
        "status": {
          "zh": "本档案未确认当地品牌、包装或供应",
          "en": "Local brand, pack and supply are not established"
        },
        "detail": {
          "zh": "请按当地药监记录、现行说明书、处方和手中药盒逐项核对。",
          "en": "Check the local regulator, current label, prescription and pack in hand item by item."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "100 Tablets／60 tablets 是一次吃的数量吗？",
          "en": "Does 100 Tablets or 60 tablets mean the amount to take at once?"
        },
        "answer": {
          "zh": "不是。它们是整瓶片数；80／120／160 mg 才是每片标签含量。网页不会把瓶装数量或 mg 变成个人片数或频次。",
          "en": "No. They are bottle counts; 80/120/160 mg is the labelled amount per tablet. The site does not turn a bottle count or milligrams into an individual's tablet count or frequency."
        }
      },
      {
        "question": {
          "zh": "BETAPACE 和 BETAPACE AF 成分一样，可以自己替换吗？",
          "en": "BETAPACE and BETAPACE AF share an ingredient; can they be self-substituted?"
        },
        "answer": {
          "zh": "不能。它们属于不同 NDA、适应证标签与患者包装路径。即使规格数字相同，也必须由开方团队和药师按准确处方核对。",
          "en": "No. They have separate NDAs, indication labelling and patient-pack pathways. Even when a strength number matches, the exact prescription needs review by the prescribing team and pharmacist."
        }
      },
      {
        "question": {
          "zh": "漏服后能不能下一次吃双倍？",
          "en": "Can the next dose be doubled after a missed dose?"
        },
        "answer": {
          "zh": "当前标签明确警示不要用下一次加倍补偿。网页不计算下一次时间；索他洛尔属于高风险抗心律失常药，漏服或中断应及时联系开方团队。",
          "en": "The current label explicitly says not to double the next dose to compensate. The site calculates no next time; sotalol is a higher-risk antiarrhythmic and a missed dose or interruption needs prompt contact with the prescribing team."
        }
      },
      {
        "question": {
          "zh": "有刻痕就可以自己掰半吗？",
          "en": "Does the score mean the tablet can be self-halved?"
        },
        "answer": {
          "zh": "不能这样推断。刻痕是准确产品的外观与标签字段；是否可分、分后剂量与处方是否匹配都必须按具体规格、现行标签、处方和药师复核。",
          "en": "No. A score is an exact-product appearance and label field. Splitting, the resulting amount and prescription fit require the exact strength, current label, prescription and pharmacist review."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "dosage-forms-are-part-of-medicine-identity",
      "same-class-is-not-same-medicine",
      "interactions-are-not-a-home-scheduling-problem"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/betapace-sotalol/",
    "en": "https://origindrug.com/en/drugs/betapace-sotalol/"
  },
  "limitations": [
    "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.",
    "Target-market current labels and official records must be checked separately."
  ]
}