{
  "id": "tribenzor",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-08-29",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "TRIBENZOR",
    "generic": "奥美沙坦酯/氨氯地平/氢氯噻嗪片",
    "aliases": [
      "Tribenzor",
      "olmesartan amlodipine hydrochlorothiazide",
      "olmesartan/amlodipine/hydrochlorothiazide",
      "olmesartan medoxomil amlodipine hydrochlorothiazide",
      "奥美沙坦氨氯地平氢氯噻嗪",
      "奥美沙坦酯氨氯地平氢氯噻嗪片",
      "olmesartan medoxomil amlodipine and hydrochlorothiazide",
      "奥美沙坦酯/氨氯地平/氢氯噻嗪",
      "奥美沙坦氨氯地平氢氯噻嗪片",
      "NDA 200175",
      "0713-0874-30",
      "0713-0875-30",
      "0713-0876-30",
      "0713-0877-30",
      "0713-0878-30",
      "TRIBENZOR C51",
      "TRIBENZOR C53",
      "TRIBENZOR C54",
      "TRIBENZOR C55",
      "TRIBENZOR C57"
    ],
    "marketBrandNames": [],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "心血管",
    "sourceArchiveMarket": "美国：DailyMed 当前 TRIBENZOR 标签（2023-07-12 更新）列示奥美沙坦酯/氨氯地平/氢氯噻嗪薄膜衣口服片、五个规格及五个准确 30 片瓶装面板；FDA Orange Book 2026-08-28 数据将 NDA 200175 五个规格均列为处方 RLD，40/10/25 mg 同时列为 RS。页面不由此推定实时库存、购买资格、其他市场包装或可替代性。",
    "dosageFormClass": "奥美沙坦酯/氨氯地平/氢氯噻嗪固定三成分薄膜衣口服片：20/5/12.5、40/5/12.5、40/5/25、40/10/12.5、40/10/25 mg；三数字按药盒成分顺序属于同一片",
    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "2010",
    "archiveSponsorText": "Cosette Pharmaceuticals, Inc.（FDA 当前申请与 DailyMed 标签记录）"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [],
    "excludedProductCues": [
      "AZOR",
      "BENICAR",
      "NORVASC",
      "MICROZIDE",
      "BENICAR HCT",
      "EXFORGE",
      "EXFORGE HCT",
      "HYZAAR",
      "DIOVAN HCT",
      "ZESTORETIC",
      "AVALIDE"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-tribenzor-olmesartan-20mg-amlodipine-5mg-hydrochlorothiazide-12-5mg-30-bottle-ndc-0713087430",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）",
        "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)"
      },
      "dosageForm": {
        "zh": "TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪薄膜衣口服片",
        "en": "TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide film-coated oral tablet"
      },
      "route": {
        "zh": "口服（固定三成分产品身份字段）",
        "en": "oral (fixed three-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0713-0874-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片奥美沙坦酯 20 mg＋氨氯地平 5 mg＋氢氯噻嗪 12.5 mg；30 片瓶装",
        "en": "Olmesartan medoxomil 20 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg per tablet; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tribenzor-06.jpg&setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "奥美沙坦酯",
            "en": "olmesartan medoxomil"
          },
          "value": 20,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片药盒顺序第一成分；不是个人片数或换算指令",
            "en": "first ingredient in the pack-order strength per tablet; not an individual tablet count or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "氨氯地平",
            "en": "amlodipine"
          },
          "value": 5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片药盒顺序第二成分；不是加用另一种降压药的指令",
            "en": "second ingredient in the pack-order strength per tablet; not an instruction to add another blood-pressure medicine"
          }
        },
        {
          "ingredient": {
            "zh": "氢氯噻嗪",
            "en": "hydrochlorothiazide"
          },
          "value": 12.5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片药盒顺序第三成分；不是个人利尿剂加减量指令",
            "en": "third ingredient in the pack-order strength per tablet; not an individual diuretic-adjustment instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "塑料瓶",
          "en": "plastic bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-29",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "橙白色",
          "en": "orange white"
        },
        "shape": {
          "zh": "圆形、无刻痕薄膜衣片，约 8 mm；无刻痕不表示可自行掰开或磨碎",
          "en": "round, unscored film-coated tablet, approximately 8 mm; an unscored tablet does not establish permission to split or crush it"
        },
        "imprint": "C51",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_993bceff99f61273",
        "label": "DailyMed（NLM）：TRIBENZOR 20/5/12.5 mg、NDC 0713-0874-30、30 片瓶装美国公开标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-29",
        "reviewedAt": "2026-08-29"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-tribenzor-olmesartan-40mg-amlodipine-5mg-hydrochlorothiazide-12-5mg-30-bottle-ndc-0713087530",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）",
        "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)"
      },
      "dosageForm": {
        "zh": "TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪薄膜衣口服片",
        "en": "TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide film-coated oral tablet"
      },
      "route": {
        "zh": "口服（固定三成分产品身份字段）",
        "en": "oral (fixed three-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0713-0875-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片奥美沙坦酯 40 mg＋氨氯地平 5 mg＋氢氯噻嗪 12.5 mg；30 片瓶装",
        "en": "Olmesartan medoxomil 40 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg per tablet; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tribenzor-07.jpg&setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "奥美沙坦酯",
            "en": "olmesartan medoxomil"
          },
          "value": 40,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片药盒顺序第一成分；不是个人片数或换算指令",
            "en": "first ingredient in the pack-order strength per tablet; not an individual tablet count or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "氨氯地平",
            "en": "amlodipine"
          },
          "value": 5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片药盒顺序第二成分；不是加用另一种降压药的指令",
            "en": "second ingredient in the pack-order strength per tablet; not an instruction to add another blood-pressure medicine"
          }
        },
        {
          "ingredient": {
            "zh": "氢氯噻嗪",
            "en": "hydrochlorothiazide"
          },
          "value": 12.5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片药盒顺序第三成分；不是个人利尿剂加减量指令",
            "en": "third ingredient in the pack-order strength per tablet; not an individual diuretic-adjustment instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "塑料瓶",
          "en": "plastic bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-29",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅黄色",
          "en": "light yellow"
        },
        "shape": {
          "zh": "圆形、无刻痕薄膜衣片，约 10 mm；无刻痕不表示可自行掰开或磨碎",
          "en": "round, unscored film-coated tablet, approximately 10 mm; an unscored tablet does not establish permission to split or crush it"
        },
        "imprint": "C53",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_993bceff99f61273",
        "label": "DailyMed（NLM）：TRIBENZOR 40/5/12.5 mg、NDC 0713-0875-30、30 片瓶装美国公开标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-29",
        "reviewedAt": "2026-08-29"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-tribenzor-olmesartan-40mg-amlodipine-5mg-hydrochlorothiazide-25mg-30-bottle-ndc-0713087630",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）",
        "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)"
      },
      "dosageForm": {
        "zh": "TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪薄膜衣口服片",
        "en": "TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide film-coated oral tablet"
      },
      "route": {
        "zh": "口服（固定三成分产品身份字段）",
        "en": "oral (fixed three-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0713-0876-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片奥美沙坦酯 40 mg＋氨氯地平 5 mg＋氢氯噻嗪 25 mg；30 片瓶装",
        "en": "Olmesartan medoxomil 40 mg plus amlodipine 5 mg plus hydrochlorothiazide 25 mg per tablet; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tribenzor-08.jpg&setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "奥美沙坦酯",
            "en": "olmesartan medoxomil"
          },
          "value": 40,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片药盒顺序第一成分；不是个人片数或换算指令",
            "en": "first ingredient in the pack-order strength per tablet; not an individual tablet count or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "氨氯地平",
            "en": "amlodipine"
          },
          "value": 5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片药盒顺序第二成分；不是加用另一种降压药的指令",
            "en": "second ingredient in the pack-order strength per tablet; not an instruction to add another blood-pressure medicine"
          }
        },
        {
          "ingredient": {
            "zh": "氢氯噻嗪",
            "en": "hydrochlorothiazide"
          },
          "value": 25,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片药盒顺序第三成分；不是个人利尿剂加减量指令",
            "en": "third ingredient in the pack-order strength per tablet; not an individual diuretic-adjustment instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "塑料瓶",
          "en": "plastic bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-29",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "浅黄色",
          "en": "light yellow"
        },
        "shape": {
          "zh": "椭圆形、无刻痕薄膜衣片，约 15 mm；无刻痕不表示可自行掰开或磨碎",
          "en": "oval, unscored film-coated tablet, approximately 15 mm; an unscored tablet does not establish permission to split or crush it"
        },
        "imprint": "C54",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_993bceff99f61273",
        "label": "DailyMed（NLM）：TRIBENZOR 40/5/25 mg、NDC 0713-0876-30、30 片瓶装美国公开标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-29",
        "reviewedAt": "2026-08-29"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-tribenzor-olmesartan-40mg-amlodipine-10mg-hydrochlorothiazide-12-5mg-30-bottle-ndc-0713087730",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）",
        "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)"
      },
      "dosageForm": {
        "zh": "TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪薄膜衣口服片",
        "en": "TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide film-coated oral tablet"
      },
      "route": {
        "zh": "口服（固定三成分产品身份字段）",
        "en": "oral (fixed three-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0713-0877-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片奥美沙坦酯 40 mg＋氨氯地平 10 mg＋氢氯噻嗪 12.5 mg；30 片瓶装",
        "en": "Olmesartan medoxomil 40 mg plus amlodipine 10 mg plus hydrochlorothiazide 12.5 mg per tablet; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tribenzor-09.jpg&setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "奥美沙坦酯",
            "en": "olmesartan medoxomil"
          },
          "value": 40,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片药盒顺序第一成分；不是个人片数或换算指令",
            "en": "first ingredient in the pack-order strength per tablet; not an individual tablet count or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "氨氯地平",
            "en": "amlodipine"
          },
          "value": 10,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片药盒顺序第二成分；不是加用另一种降压药的指令",
            "en": "second ingredient in the pack-order strength per tablet; not an instruction to add another blood-pressure medicine"
          }
        },
        {
          "ingredient": {
            "zh": "氢氯噻嗪",
            "en": "hydrochlorothiazide"
          },
          "value": 12.5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片药盒顺序第三成分；不是个人利尿剂加减量指令",
            "en": "third ingredient in the pack-order strength per tablet; not an individual diuretic-adjustment instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "塑料瓶",
          "en": "plastic bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-29",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "灰红色",
          "en": "grayish red"
        },
        "shape": {
          "zh": "圆形、无刻痕薄膜衣片，约 10 mm；无刻痕不表示可自行掰开或磨碎",
          "en": "round, unscored film-coated tablet, approximately 10 mm; an unscored tablet does not establish permission to split or crush it"
        },
        "imprint": "C55",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_993bceff99f61273",
        "label": "DailyMed（NLM）：TRIBENZOR 40/10/12.5 mg、NDC 0713-0877-30、30 片瓶装美国公开标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-29",
        "reviewedAt": "2026-08-29"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-tribenzor-olmesartan-40mg-amlodipine-10mg-hydrochlorothiazide-25mg-30-bottle-ndc-0713087830",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）",
        "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)"
      },
      "dosageForm": {
        "zh": "TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪薄膜衣口服片",
        "en": "TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide film-coated oral tablet"
      },
      "route": {
        "zh": "口服（固定三成分产品身份字段）",
        "en": "oral (fixed three-ingredient product-identity field)"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0713-0878-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片奥美沙坦酯 40 mg＋氨氯地平 10 mg＋氢氯噻嗪 25 mg；30 片瓶装",
        "en": "Olmesartan medoxomil 40 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg per tablet; 30-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tribenzor-0a.jpg&setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "奥美沙坦酯",
            "en": "olmesartan medoxomil"
          },
          "value": 40,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片药盒顺序第一成分；不是个人片数或换算指令",
            "en": "first ingredient in the pack-order strength per tablet; not an individual tablet count or conversion instruction"
          }
        },
        {
          "ingredient": {
            "zh": "氨氯地平",
            "en": "amlodipine"
          },
          "value": 10,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片药盒顺序第二成分；不是加用另一种降压药的指令",
            "en": "second ingredient in the pack-order strength per tablet; not an instruction to add another blood-pressure medicine"
          }
        },
        {
          "ingredient": {
            "zh": "氢氯噻嗪",
            "en": "hydrochlorothiazide"
          },
          "value": 25,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片药盒顺序第三成分；不是个人利尿剂加减量指令",
            "en": "third ingredient in the pack-order strength per tablet; not an individual diuretic-adjustment instruction"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "塑料瓶",
          "en": "plastic bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-29",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_inventory",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "片/瓶",
          "en": "tablets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "灰红色",
          "en": "grayish red"
        },
        "shape": {
          "zh": "椭圆形、无刻痕薄膜衣片，约 15 mm；无刻痕不表示可自行掰开或磨碎",
          "en": "oval, unscored film-coated tablet, approximately 15 mm; an unscored tablet does not establish permission to split or crush it"
        },
        "imprint": "C57",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_993bceff99f61273",
        "label": "DailyMed（NLM）：TRIBENZOR 40/10/25 mg、NDC 0713-0878-30、30 片瓶装美国公开标签面板",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-29",
        "reviewedAt": "2026-08-29"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "presentationId": "us-tribenzor-olmesartan-20mg-amlodipine-5mg-hydrochlorothiazide-12-5mg-30-bottle-ndc-0713087430",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tribenzor-06.jpg&setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
    "alt": {
      "zh": "DailyMed 当前 TRIBENZOR 20/5/12.5 mg、NDC 0713-0874-30、30 片瓶装标签面板",
      "en": "Current DailyMed TRIBENZOR 20/5/12.5 mg, NDC 0713-0874-30, 30-tablet bottle label panel"
    },
    "archiveMarket": "美国",
    "labelVersion": "DailyMed 美国当前公开标签（2023-07-12 更新）",
    "presentation": "TRIBENZOR 每片奥美沙坦酯 20 mg/氨氯地平 5 mg/氢氯噻嗪 12.5 mg，NDC 0713-0874-30，30 片瓶装。",
    "notice": "此图只对应当前标签中的 TRIBENZOR 20/5/12.5 mg、NDC 0713-0874-30、30 片瓶装面板；不能代表另四个规格、其他市场或仿制药，不用于鉴定真伪，也不证明实时库存、个人片数或可替代性。",
    "source": {
      "id": "src_993bceff99f61273",
      "label": "DailyMed（NLM）：TRIBENZOR 20/5/12.5 mg、NDC 0713-0874-30、30 片瓶装美国公开标签面板",
      "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-29",
      "reviewedAt": "2026-08-29"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "TRIBENZOR 说明书放大阅读：一片已有三种降压成分，先核对奥美沙坦、氨氯地平和氢氯噻嗪是否重复",
      "en": "TRIBENZOR label reading: one tablet already contains three blood-pressure ingredients; first check duplicate olmesartan, amlodipine and hydrochlorothiazide"
    },
    "summary": {
      "zh": "TRIBENZOR 每片固定含奥美沙坦酯、氨氯地平和氢氯噻嗪。例如 40/10/25 mg 表示同一片内三种成分各自的标签量；不能理解成三片、分片或可与单方/双联产品直接相加换算。当前标签还明确本固定复方不用于高血压初始治疗，这不是网页替个人决定开始、停用或换药。",
      "en": "Each TRIBENZOR tablet contains fixed amounts of olmesartan medoxomil, amlodipine and hydrochlorothiazide. For example, 40/10/25 mg states the labelled amount of each ingredient in one tablet; it is not three tablets, a splitting cue or a sum that can be directly converted with single- or dual-ingredient products. The current label also states that this fixed combination is not indicated for initial hypertension therapy; that is not a website decision to start, stop or switch an individual's medicine."
    },
    "checks": [
      {
        "zh": "逐盒看有效成分。AZOR 已含奥美沙坦和氨氯地平，BENICAR、NORVASC、MICROZIDE 分别是可能重复的单方成分；BENICAR HCT、EXFORGE HCT、HYZAAR、DIOVAN HCT、ZESTORETIC、AVALIDE 也可能共享一种或多种成分。若同时出现在药单，不要自行删掉或加上任何一盒，应由药师或开方团队结合完整处方判断。",
        "en": "Read the active ingredients on every pack. AZOR already contains olmesartan and amlodipine; BENICAR, NORVASC and MICROZIDE are single-ingredient products that may duplicate one component. BENICAR HCT, EXFORGE HCT, HYZAAR, DIOVAN HCT, ZESTORETIC and AVALIDE may also share one or more ingredients. If they appear together, do not add or remove a pack yourself; a pharmacist or prescriber must review the complete prescriptions."
      },
      {
        "zh": "标签有胎儿毒性黑框警示。已经怀孕、可能怀孕或计划怀孕者应立即联系开方团队核对；不要等待网页判断，也不要自行安排停换药。",
        "en": "The label carries a boxed warning for fetal toxicity. Anyone who is pregnant, may be pregnant or plans pregnancy should contact the prescribing team promptly; do not wait for a website decision or arrange stopping or switching independently."
      },
      {
        "zh": "老人或体弱者若明显头晕、晕厥、跌倒、尿量减少，或持续呕吐腹泻并有脱水迹象，应及时联系医疗团队；严重或突然时使用当地急救服务。三成分共同涉及血压、肾功能、电解质和体液状态，网页不按年龄或单次数字生成方案。",
        "en": "Older or frail adults with marked dizziness, fainting, a fall, reduced urine, or persistent vomiting or diarrhoea with dehydration signs should contact the care team promptly; use local emergency services for severe or sudden symptoms. The three ingredients jointly make blood pressure, kidney function, electrolytes and fluid status relevant; the site does not generate a regimen from age or one reading."
      },
      {
        "zh": "严重、持续的慢性腹泻并伴明显体重下降，可能与标签所述类乳糜泻性肠病有关，即使已使用数月或数年也应尽快联系医疗团队；出现脱水、晕厥、意识异常或无法进水时使用当地急救服务。",
        "en": "Severe, persistent chronic diarrhoea with substantial weight loss may relate to the labelled sprue-like enteropathy, even after months or years of use, and warrants prompt contact with the care team. Use local emergency services for dehydration, fainting, altered consciousness or inability to take fluids."
      },
      {
        "zh": "突然眼痛或视力下降属于氢氯噻嗪标签中的急性近视/继发性闭角型青光眼警示，应立即寻求医疗帮助；网页不等待照片识别，也不提供自行停换药方案。",
        "en": "Sudden eye pain or reduced vision falls within the hydrochlorothiazide label warning for acute myopia/secondary angle-closure glaucoma and needs immediate medical attention. Do not wait for photo identification or use the site for a self-directed stopping or switching plan."
      },
      {
        "zh": "标签提示氢氯噻嗪与非黑色素瘤皮肤癌风险增加有关，并建议防晒和定期皮肤检查。这不表示网页可以从皮肤照片诊断；发现新生、变化或不愈合皮损时应联系专业人员。",
        "en": "The label associates hydrochlorothiazide with increased non-melanoma skin-cancer risk and advises sun protection and regular skin screening. This does not let the site diagnose a skin photograph; contact a professional for a new, changing or non-healing lesion."
      },
      {
        "zh": "糖尿病患者合用阿利吉仑属于标签禁忌边界。其他 RAS 药物、NSAID、锂盐、含钾补充剂或代盐、考来维仑，以及氨氯地平与辛伐他汀（标签写明 20 mg/日上限）均须按准确产品和完整药单核对；网页不改变个人剂量或安排间隔。",
        "en": "The label contraindicates aliskiren coadministration in patients with diabetes. Other RAS medicines, NSAIDs, lithium, potassium supplements or salt substitutes, colesevelam, and amlodipine with simvastatin (the label states a 20 mg/day limit) require exact-product and full-list review. The site does not change an individual's dose or arrange an interval."
      },
      {
        "zh": "五种片剂均为薄膜衣、无刻痕；圆形与椭圆形、颜色、印字和 NDC 只用于包装身份核对。无刻痕不等于可自行掰开、磨碎或按颜色换药。",
        "en": "All five tablets are film-coated and unscored; round or oval shape, colour, imprint and NDC are product-identity clues only. An unscored tablet does not permit self-splitting, crushing or colour-based switching."
      }
    ],
    "source": {
      "id": "src_993bceff99f61273",
      "label": "DailyMed（NLM）：TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪当前美国公开标签（2023-07-12 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-29",
      "reviewedAt": "2026-08-29"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "三种成分怎样协同：ARB、钙通道阻滞剂与噻嗪类利尿剂三条路径",
      "en": "How three ingredients work together: ARB, calcium-channel blocker and thiazide-diuretic pathways"
    },
    "summary": {
      "zh": "当前标签说明：奥美沙坦阻断血管紧张素 II 的 AT1 受体作用；氨氯地平帮助外周动脉舒张；氢氯噻嗪影响肾小管对电解质的重吸收并增加钠、氯排泄。三条路径放在同一片中，不表示网页能按血压、尿量或化验数字拆分或重组个人方案。",
      "en": "The current label explains that olmesartan blocks angiotensin II activity at the AT1 receptor, amlodipine supports peripheral arterial vasodilation, and hydrochlorothiazide affects renal-tubular electrolyte reabsorption and increases sodium and chloride excretion. Combining three pathways in one tablet does not let the site split or rebuild an individual's regimen from blood pressure, urine output or a laboratory result."
    },
    "checks": [
      {
        "zh": "共同的降压目的不表示单方、双联与三联产品可自行叠加或换算。三种成分分别使完整药单、血压、肾功能、电解质、体液状态与相互作用核对更重要。",
        "en": "A shared blood-pressure purpose does not make single-, dual- and triple-ingredient products self-combinable or convertible. The three ingredients make review of the complete medicine list, blood pressure, kidney function, electrolytes, fluid status and interactions especially important."
      },
      {
        "zh": "药盒三数字按奥美沙坦酯/氨氯地平/氢氯噻嗪排列；Orange Book 数据的成分和强度按其数据字段顺序呈现。必须连同成分名称读取，不能把第一个数字机械对到另一个列表的第一个成分。",
        "en": "The pack orders its three numbers as olmesartan medoxomil/amlodipine/hydrochlorothiazide, while Orange Book ingredient and strength fields follow that dataset's order. Read the ingredient names with the numbers; do not mechanically map the first number to the first ingredient in another list."
      },
      {
        "zh": "机制页面不能处理突发胸痛、晕厥、严重呼吸困难、眼痛/视力下降、严重脱水、过敏或其他急性严重不适。出现这些担忧时使用当地医疗支持，不从机制文字自行调整。",
        "en": "A mechanism page cannot manage sudden chest pain, fainting, severe breathing difficulty, eye pain/reduced vision, severe dehydration, allergy or another acute severe problem. Use local medical support rather than self-adjusting from mechanism text."
      }
    ],
    "source": {
      "id": "src_993bceff99f61273",
      "label": "DailyMed（NLM）：TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪当前美国公开标签（2023-07-12 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-29",
      "reviewedAt": "2026-08-29"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "TRIBENZOR",
      "generic": "奥美沙坦酯/氨氯地平/氢氯噻嗪片",
      "dosageFormClass": "奥美沙坦酯/氨氯地平/氢氯噻嗪固定三成分薄膜衣口服片：20/5/12.5、40/5/12.5、40/5/25、40/10/12.5、40/10/25 mg；三数字按药盒成分顺序属于同一片"
    },
    "labelSource": {
      "id": "src_993bceff99f61273",
      "label": "DailyMed（NLM）：TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪当前美国公开标签（2023-07-12 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-29",
      "reviewedAt": "2026-08-29"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_993bceff99f61273",
          "label": "DailyMed（NLM）：TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪当前美国公开标签（2023-07-12 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        },
        "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": "2026-08-29",
        "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_10e511bf83430e3b",
          "label": "FDA Orange Book 当前数据：TRIBENZOR，NDA 200175，五个口服片规格均列为处方 RLD；40/10/25 mg 同时列为 RS",
          "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_dataset",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        },
        "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": "2026-08-29",
        "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_9ddcb06f7196a1e3",
          "label": "FDA Drugs@FDA 官方检索入口：TRIBENZOR NDA 200175 原始批准与申请记录",
          "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_dataset",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_requires_interaction",
          "accessMode": "interactive_lookup",
          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        },
        "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": "2026-08-29",
        "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": "2026-08-29",
      "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": "TRIBENZOR 一片同时含奥美沙坦酯、氨氯地平和氢氯噻嗪。药盒上的三组数字表示同一片内三种成分各有多少毫克，不是三片、分片或加减公式。若药单还有 AZOR、BENICAR、NORVASC、MICROZIDE，或 BENICAR HCT、EXFORGE HCT、HYZAAR、DIOVAN HCT、ZESTORETIC、AVALIDE 等可能共享成分的产品，应带所有药盒和处方让药师或开方团队逐项核对，不要自行叠加、停药、轮换或按毫克换算。",
    "history": "FDA 原始批准函与 Orange Book 记录 TRIBENZOR NDA 200175 于 2010-07-23 获批，五个规格均为处方 RLD；当前数据将 40/10/25 mg 同时列为 RS。DailyMed 当前标签页面于 2023-07-12 更新，五个 NDC 的 30 片瓶装营销起始日期列为 2022-09-01，未列营销结束日期；这仍不是实时库存证明。",
    "sourceDocuments": [
      {
        "id": "src_993bceff99f61273",
        "label": "DailyMed（NLM）：TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪当前美国公开标签（2023-07-12 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-29",
        "reviewedAt": "2026-08-29"
      },
      {
        "id": "src_10e511bf83430e3b",
        "label": "FDA Orange Book 当前数据：TRIBENZOR，NDA 200175，五个口服片规格均列为处方 RLD；40/10/25 mg 同时列为 RS",
        "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_dataset",
        "documentKind": "regulatory_product_record",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-29",
        "reviewedAt": "2026-08-29"
      },
      {
        "id": "src_9ddcb06f7196a1e3",
        "label": "FDA Drugs@FDA 官方检索入口：TRIBENZOR NDA 200175 原始批准与申请记录",
        "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_dataset",
        "documentKind": "regulatory_product_record",
        "market": "US",
        "accessStatus": "public_access_requires_interaction",
        "accessMode": "interactive_lookup",
        "accessVerifiedAt": "2026-08-29",
        "reviewedAt": "2026-08-29"
      },
      {
        "id": "src_3774a6b7c7a72aab",
        "label": "FDA：TRIBENZOR NDA 200175 原始批准函（2010-07-23）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200175s000ltr.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_regulatory_record",
        "documentKind": "regulatory_review",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_pdf",
        "accessVerifiedAt": "2026-08-29",
        "reviewedAt": "2026-08-29"
      },
      {
        "id": "src_4b54955586218a69",
        "label": "FDA：TRIBENZOR NDA 200175 原始审评资料（505(b)(2)，2010）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200175Orig1s000OtherR.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_regulatory_record",
        "documentKind": "regulatory_review",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_pdf",
        "accessVerifiedAt": "2026-08-29",
        "reviewedAt": "2026-08-29"
      }
    ],
    "applicationNumber": "FDA NDA 200175（TRIBENZOR / olmesartan medoxomil, amlodipine and hydrochlorothiazide oral tablets）",
    "approvalTimeline": [
      {
        "date": "2010-07-23",
        "title": {
          "zh": "TRIBENZOR 原始批准",
          "en": "Original TRIBENZOR approval"
        },
        "detail": {
          "zh": "FDA 批准函和当前 Orange Book 数据记录 NDA 200175 的五个固定三成分规格。",
          "en": "The FDA approval letter and current Orange Book data record five fixed three-ingredient strengths under NDA 200175."
        },
        "source": {
          "id": "src_3774a6b7c7a72aab",
          "label": "FDA：TRIBENZOR NDA 200175 原始批准函（2010-07-23）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200175s000ltr.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_regulatory_record",
          "documentKind": "regulatory_review",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_pdf",
          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        }
      },
      {
        "date": "2022-09-01",
        "title": {
          "zh": "当前五个 NDC 标签营销起始日期",
          "en": "Current label marketing-start date for five NDCs"
        },
        "detail": {
          "zh": "DailyMed 当前页面对五个 30 片瓶装 NDC 均列 2022-09-01 为营销起始日期且未列结束日期；这不是实时库存证明。",
          "en": "The current DailyMed page lists 1 Sep 2022 as the marketing-start date for all five 30-tablet bottle NDCs and no end date; this is not real-time stock evidence."
        },
        "source": {
          "id": "src_993bceff99f61273",
          "label": "DailyMed（NLM）：TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪当前美国公开标签（2023-07-12 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        }
      },
      {
        "date": "2023-07-12",
        "title": {
          "zh": "当前公开标签页面更新",
          "en": "Current public label page updated"
        },
        "detail": {
          "zh": "DailyMed 当前页面列示五个规格、五个准确 30 片瓶装面板、外观和放大安全信息。",
          "en": "The current DailyMed page lists five strengths, five exact 30-tablet bottle panels, appearance and enlarged safety information."
        },
        "source": {
          "id": "src_993bceff99f61273",
          "label": "DailyMed（NLM）：TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪当前美国公开标签（2023-07-12 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        }
      },
      {
        "date": "2026-08-28",
        "title": {
          "zh": "当前 Orange Book 身份核验",
          "en": "Current Orange Book identity reviewed"
        },
        "detail": {
          "zh": "当前数据将五个规格均列为处方 RLD，并将 40/10/25 mg 列为 RS。",
          "en": "Current data list all five strengths as prescription RLD products and 40/10/25 mg as the RS."
        },
        "source": {
          "id": "src_10e511bf83430e3b",
          "label": "FDA Orange Book 当前数据：TRIBENZOR，NDA 200175，五个口服片规格均列为处方 RLD；40/10/25 mg 同时列为 RS",
          "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_dataset",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "status": {
          "zh": "五个处方 RLD 规格；40/10/25 mg 同时为 RS；五个当前标签 NDC 无营销结束日期",
          "en": "Five prescription RLD strengths; 40/10/25 mg also RS; five current-label NDCs have no marketing end date"
        },
        "detail": {
          "zh": "这些官方记录支持核对产品身份，不证明药房实时库存、购买资格或可替代性。",
          "en": "These official records support product-identity review; they do not establish real-time pharmacy stock, purchasing eligibility or interchangeability."
        }
      },
      {
        "market": {
          "zh": "中国大陆及其他市场",
          "en": "Mainland China and other markets"
        },
        "status": {
          "zh": "待逐项建立现行市场记录",
          "en": "Current market record not established"
        },
        "detail": {
          "zh": "不从美国品牌、共同成分或 mg 数字推定当地批准、商品名、包装、供应或可替代性。",
          "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients or milligram numbers."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "40/10/25 mg 是不是三片药？",
          "en": "Does 40/10/25 mg mean three tablets?"
        },
        "answer": {
          "zh": "不是。它表示同一片内有奥美沙坦酯 40 mg、氨氯地平 10 mg 和氢氯噻嗪 25 mg。网页不会把三数字转换为分片、磨碎或个人片数。",
          "en": "No. It means one tablet contains olmesartan medoxomil 40 mg, amlodipine 10 mg and hydrochlorothiazide 25 mg. The site does not convert the three numbers into splitting, crushing or an individual tablet count."
        }
      },
      {
        "question": {
          "zh": "已经吃 TRIBENZOR，还能再吃 AZOR、NORVASC 或利尿药吗？",
          "en": "Can AZOR, NORVASC or a diuretic be taken in addition to TRIBENZOR?"
        },
        "answer": {
          "zh": "网页不能替个人决定。TRIBENZOR 已含奥美沙坦、氨氯地平和氢氯噻嗪，另一个共享成分产品可能重复，也可能是专业人员有意安排；只有准确处方、实际药盒和完整药单才能判断。不要自行加上或停掉任何一盒。",
          "en": "The site cannot decide for an individual. TRIBENZOR already contains olmesartan, amlodipine and hydrochlorothiazide, so another shared-ingredient product may be duplicative or intentionally prescribed. Only exact prescriptions, packs and the complete medicine list can establish that. Do not add or stop a pack yourself."
        }
      },
      {
        "question": {
          "zh": "Orange Book 为什么把数字顺序写得不一样？",
          "en": "Why can Orange Book show the numbers in a different order?"
        },
        "answer": {
          "zh": "药盒按奥美沙坦酯/氨氯地平/氢氯噻嗪排列；Orange Book 当前数据把成分列为氨氯地平/氢氯噻嗪/奥美沙坦酯，并按同一顺序列强度。两边都必须连同成分名称读取，不能只看数字位置。",
          "en": "The pack orders olmesartan medoxomil/amlodipine/hydrochlorothiazide, while current Orange Book data list amlodipine/hydrochlorothiazide/olmesartan medoxomil and order strengths accordingly. Read ingredient names with both lists rather than comparing number positions alone."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "how-to-read-a-drug-label",
      "dosage-forms-are-part-of-medicine-identity"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/tribenzor/",
    "en": "https://origindrug.com/en/drugs/tribenzor/"
  },
  "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."
  ]
}