{
  "id": "lozol-indapamide",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-09-04",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "LOZOL / indapamide",
    "generic": "吲达帕胺普通片",
    "aliases": [
      "LOZOL",
      "Lozol",
      "indapamide",
      "indapamide tablets",
      "吲达帕胺",
      "吲达帕胺片",
      "NDA 018538",
      "ANDA 074299",
      "62559-510-01",
      "62559-511-01",
      "ANI 510",
      "ANI 511"
    ],
    "marketBrandNames": [
      {
        "name": "LOZOL",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "evidenceStatus": "historical_regulatory_record",
        "note": {
          "zh": "NDA 018538 历史原研/RLD；1.25/2.5 mg 已停市，且不是因安全性或有效性撤回。本页不展示原品牌包装。",
          "en": "Historical originator/RLD under NDA 018538; 1.25/2.5 mg discontinued, not withdrawn for safety or effectiveness. No original-brand pack is displayed."
        },
        "source": {
          "id": "src_b6d76767d72b9883",
          "label": "FDA Drugs@FDA：LOZOL NDA 018538 历史原研/RLD、初始批准与停市原因边界",
          "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018538",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_regulatory_document",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-04",
          "reviewedAt": "2026-09-04"
        }
      },
      {
        "name": "indapamide",
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "evidenceStatus": "current_regulatory_record",
        "note": {
          "zh": "ANI ANDA 074299 当前通用药标签；监管记录不等于实时库存。",
          "en": "Current ANI generic label under ANDA 074299; a regulatory listing is not live stock."
        },
        "source": {
          "id": "src_75b816aca5469bf8",
          "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-04",
          "reviewedAt": "2026-09-04"
        }
      }
    ],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "心血管",
    "sourceArchiveMarket": "FDA 将 LOZOL NDA 018538 记录为历史原研/RLD，1.25 mg 与 2.5 mg 均已停市，且不是因安全性或有效性原因撤回。当前准确包装来自 ANI ANDA 074299 通用药标签；历史品牌、当前通用药、缓释片和复方不得混写。",
    "dosageFormClass": "吲达帕胺普通口服片。LOZOL 历史品牌、ANI 当前普通片、各地缓释片及含吲达帕胺复方属于不同准确产品；共同成分不建立包装、释放方式、强度或替换结论。",
    "dosageFormClassCode": "oral_modified_release",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "1983-07-06",
    "archiveSponsorText": "LOZOL 历史原研/RLD；ANI Pharmaceuticals, Inc. 为当前展示通用药标签方"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [
      "LOZOL",
      "indapamide",
      "indapamide tablets",
      "吲达帕胺",
      "吲达帕胺片"
    ],
    "excludedProductCues": [
      "indapamide sustained release",
      "indapamide SR",
      "indapamide modified release",
      "吲达帕胺缓释片",
      "WIDAPLIK",
      "telmisartan amlodipine indapamide",
      "hydrochlorothiazide",
      "chlorthalidone",
      "furosemide"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-ani-indapamide-1-25mg-100-tablet-bottle-ndc-6255951001",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前 ANI 通用药标签（2025-09-12 更新）",
        "en": "Current ANI generic DailyMed label (updated 12 Sep 2025)"
      },
      "dosageForm": {
        "zh": "吲达帕胺普通口服片",
        "en": "indapamide immediate-release oral tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 62559-510-01",
      "pouchCode": null,
      "applicationNumber": "ANDA 074299",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片吲达帕胺 1.25 mg；100 片瓶装",
        "en": "1.25 mg indapamide per tablet; 100-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Label-125.jpg&setid=deb83f97-6c61-4a09-bed6-18dcf1183405",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "吲达帕胺",
            "en": "indapamide"
          },
          "value": 1.25,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、频次或与其他利尿药的换算值",
            "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion to another diuretic"
          }
        }
      ],
      "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": "2026-09-04",
        "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": "橙色",
          "en": "orange"
        },
        "shape": {
          "zh": "圆形普通片",
          "en": "round immediate-release tablet"
        },
        "imprint": "ANI 510",
        "scoreStatus": "unscored_no_split_permission_inferred",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_75b816aca5469bf8",
        "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-04",
        "reviewedAt": "2026-09-04"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-ani-indapamide-2-5mg-100-tablet-bottle-ndc-6255951101",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前 ANI 通用药标签（2025-09-12 更新）",
        "en": "Current ANI generic DailyMed label (updated 12 Sep 2025)"
      },
      "dosageForm": {
        "zh": "吲达帕胺普通口服片",
        "en": "indapamide immediate-release oral tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 62559-511-01",
      "pouchCode": null,
      "applicationNumber": "ANDA 074299",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片吲达帕胺 2.5 mg；100 片瓶装",
        "en": "2.5 mg indapamide per tablet; 100-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Label-25.jpg&setid=deb83f97-6c61-4a09-bed6-18dcf1183405",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "吲达帕胺",
            "en": "indapamide"
          },
          "value": 2.5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、频次或与其他利尿药的换算值",
            "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion to another diuretic"
          }
        }
      ],
      "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": "2026-09-04",
        "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": "白色",
          "en": "white"
        },
        "shape": {
          "zh": "圆形普通片",
          "en": "round immediate-release tablet"
        },
        "imprint": "ANI 511",
        "scoreStatus": "unscored_no_split_permission_inferred",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_75b816aca5469bf8",
        "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-04",
        "reviewedAt": "2026-09-04"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "presentationId": "us-ani-indapamide-1-25mg-100-tablet-bottle-ndc-6255951001",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Label-125.jpg&setid=deb83f97-6c61-4a09-bed6-18dcf1183405",
    "alt": "ANI 吲达帕胺 1.25 mg、NDC 62559-510-01、100 片瓶装的 DailyMed 官方通用药标签面板",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed 2025-09",
    "presentation": "1.25 mg 橙色圆片、ANI 510、无刻痕；另有 2.5 mg 白色圆片 ANI 511。",
    "notice": "这是 ANI 当前通用药标签，不是 LOZOL 原品牌包装；不代表缓释片、复方或其他市场供应，也不用于鉴定真伪。",
    "source": {
      "id": "src_75b816aca5469bf8",
      "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-04",
      "reviewedAt": "2026-09-04"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "吲达帕胺说明书放大阅读：分清历史 LOZOL、当前通用药、普通片与缓释片",
      "en": "Indapamide enlarged label: separate historical LOZOL, the current generic, immediate and modified release"
    },
    "summary": {
      "zh": "1.25 mg 与 2.5 mg 是每片含量；100 Tablets 是整瓶片数。当前 ANI 两种片剂均无刻痕，网页不从算术生成掰片、加减量或替换许可。",
      "en": "The 1.25 mg and 2.5 mg figures are per-tablet amounts; 100 Tablets is the bottle count. Both current ANI tablets are unscored, and arithmetic does not create permission to split, change an amount or substitute."
    },
    "checks": [
      {
        "zh": "标签提示严重低钠可伴低钾，报告主要见于老年女性。乏力、嗜睡、意识或步态变化、肌肉痉挛、心悸、晕厥应及时核对钠、钾、肾功能和完整药单；严重时使用当地急救。",
        "en": "The label warns that severe hyponatraemia may occur with hypokalaemia, reported primarily in older women. Weakness, somnolence, altered awareness or gait, cramps, palpitations or fainting need prompt sodium, potassium, kidney and full-list review; use local emergency care when severe."
      },
      {
        "zh": "老人、进食饮水减少、呕吐腹泻或同时使用其他降压/利尿药时，更易出现脱水、站立性低血压和跌倒；不要据水肿、体重或家庭血压自行加减、停用或隔日轮换。",
        "en": "Older age, reduced intake, vomiting/diarrhoea or another antihypertensive/diuretic can increase dehydration, orthostatic hypotension and falls. Do not self-change, stop or alternate from oedema, weight or home pressure alone."
      },
      {
        "zh": "锂、地高辛/其他强心苷、糖皮质激素或 ACTH、其他利尿剂同处药单时，应优先核对药物浓度、心律、电解质、肾功能和重复用药；不要自行错开或删除其中一盒。",
        "en": "Lithium, digoxin/another cardiac glycoside, a corticosteroid or ACTH, or another diuretic requires priority review of concentrations, rhythm, electrolytes, kidney function and duplication. Do not self-space or remove a pack."
      },
      {
        "zh": "突发视力下降、眼痛或眼红可能涉及脉络膜积液或急性闭角型青光眼，应立即就医；网页不能用照片排除眼科急症。",
        "en": "Sudden reduced vision, eye pain or redness may involve choroidal effusion or acute angle-closure glaucoma and needs immediate care; a photo cannot exclude an eye emergency."
      }
    ],
    "source": {
      "id": "src_75b816aca5469bf8",
      "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-04",
      "reviewedAt": "2026-09-04"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "吲达帕胺怎样利尿降压：作用机制不等于所有利尿药按 mg 互换",
      "en": "How indapamide causes diuresis and lowers pressure: mechanism does not make diuretics milligram-interchangeable"
    },
    "summary": {
      "zh": "吲达帕胺属于磺酰胺类利尿降压药，影响肾小管电解质处理。机制可解释水分、电解质与血压变化，但不能决定个人片数、补钾、服用时间或联用方案。",
      "en": "Indapamide is a sulfonamide-derived diuretic antihypertensive affecting tubular electrolyte handling. Mechanism helps explain fluid, electrolyte and pressure changes but cannot determine tablet count, potassium use, timing or combinations."
    },
    "checks": [
      {
        "zh": "吲达帕胺、氯噻酮、氢氯噻嗪、呋塞米、螺内酯和依普利酮不是同一种药；共同用途不建立 mg 换算、轮换或叠加规则。",
        "en": "Indapamide, chlorthalidone, hydrochlorothiazide, furosemide, spironolactone and eplerenone are not one medicine. Shared purpose does not establish milligram conversion, alternation or combination."
      },
      {
        "zh": "普通片与缓释/改良释放片的释放结构、规格和标签不同，不能仅按共同成分自行替换、压碎、掰分或拼片。",
        "en": "Immediate- and modified-release tablets differ in release structure, strength and label and cannot be self-substituted, crushed, divided or assembled from a shared ingredient."
      },
      {
        "zh": "低钾风险不表示人人都应自行补钾；补钾、含钾代盐或保钾药物必须结合化验、肾功能和完整药单。",
        "en": "A low-potassium risk does not mean everyone should self-supplement; potassium, potassium salt substitutes or potassium-sparing medicines require laboratory, kidney and full-list review."
      }
    ],
    "source": {
      "id": "src_61e211239f8fb6af",
      "label": "FDA：LOZOL 1.25 mg 历史品牌说明书（2021-03）",
      "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018538s030lbl.pdf",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_regulatory_document",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "direct_document",
      "accessVerifiedAt": "2026-09-04",
      "reviewedAt": "2026-09-04"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "LOZOL / indapamide",
      "generic": "吲达帕胺普通片",
      "dosageFormClass": "吲达帕胺普通口服片。LOZOL 历史品牌、ANI 当前普通片、各地缓释片及含吲达帕胺复方属于不同准确产品；共同成分不建立包装、释放方式、强度或替换结论。"
    },
    "labelSource": {
      "id": "src_75b816aca5469bf8",
      "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-04",
      "reviewedAt": "2026-09-04"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_75b816aca5469bf8",
          "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-04",
          "reviewedAt": "2026-09-04"
        },
        "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": "2026-09-04",
        "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_b6d76767d72b9883",
          "label": "FDA Drugs@FDA：LOZOL NDA 018538 历史原研/RLD、初始批准与停市原因边界",
          "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018538",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_regulatory_document",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-04",
          "reviewedAt": "2026-09-04"
        },
        "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": "2026-09-04",
        "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_61e211239f8fb6af",
          "label": "FDA：LOZOL 1.25 mg 历史品牌说明书（2021-03）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018538s030lbl.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_regulatory_document",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-04",
          "reviewedAt": "2026-09-04"
        },
        "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": "2026-09-04",
        "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": "2026-09-04",
      "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": "LOZOL 是吲达帕胺的美国历史原研/RLD；本页图片是当前 ANI 通用药，不是 LOZOL 原品牌包装。1.25/2.5 mg 是每片含量，100 Tablets 是整瓶片数。老人，特别是老年女性，应优先核对低钠合并低钾、脱水、头晕和跌倒；锂、地高辛/强心苷、激素、其他利尿剂或降压药同处药单时需专业核对。",
    "history": "LOZOL NDA 018538 于 1983-07-06 作为新分子实体获批。FDA 记录两个历史规格已停市但不是因安全性或有效性原因。2021 年品牌标签更新加入脉络膜积液及急性闭角型青光眼相关警示；2025 年更新的 ANI DailyMed 标签用于展示当前通用药准确包装。",
    "sourceDocuments": [
      {
        "id": "src_75b816aca5469bf8",
        "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-04",
        "reviewedAt": "2026-09-04"
      },
      {
        "id": "src_b6d76767d72b9883",
        "label": "FDA Drugs@FDA：LOZOL NDA 018538 历史原研/RLD、初始批准与停市原因边界",
        "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018538",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_regulatory_document",
        "documentKind": "regulatory_product_record",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-04",
        "reviewedAt": "2026-09-04"
      },
      {
        "id": "src_61e211239f8fb6af",
        "label": "FDA：LOZOL 1.25 mg 历史品牌说明书（2021-03）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018538s030lbl.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_regulatory_document",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-04",
        "reviewedAt": "2026-09-04"
      },
      {
        "id": "src_067ce3340f851c18",
        "label": "FDA：LOZOL 2021 年补充批准函（脉络膜积液/闭角型青光眼警示更新）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018538Orig1s030ltr.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_regulatory_document",
        "documentKind": "regulatory_approval_letter",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-04",
        "reviewedAt": "2026-09-04"
      }
    ],
    "applicationNumber": "LOZOL NDA 018538（历史原研/RLD）；ANI indapamide ANDA 074299（当前通用药标签）",
    "approvalTimeline": [
      {
        "date": "1983-07-06",
        "title": {
          "zh": "LOZOL 美国初始批准",
          "en": "Initial U.S. approval of LOZOL"
        },
        "detail": {
          "zh": "NDA 018538，Type 1 新分子实体；历史原研/RLD。",
          "en": "NDA 018538, Type 1 new molecular entity; historical originator/RLD."
        },
        "source": {
          "id": "src_b6d76767d72b9883",
          "label": "FDA Drugs@FDA：LOZOL NDA 018538 历史原研/RLD、初始批准与停市原因边界",
          "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018538",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_regulatory_document",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-04",
          "reviewedAt": "2026-09-04"
        }
      },
      {
        "date": "2021-03-02",
        "title": {
          "zh": "FDA 批准眼部风险警示更新",
          "en": "FDA approved ocular-risk warning update"
        },
        "detail": {
          "zh": "补充批准函加入脉络膜积液相关语言并更新急性闭角型青光眼警示。",
          "en": "The supplement approval added choroidal-effusion language and updated the acute angle-closure glaucoma warning."
        },
        "source": {
          "id": "src_067ce3340f851c18",
          "label": "FDA：LOZOL 2021 年补充批准函（脉络膜积液/闭角型青光眼警示更新）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018538Orig1s030ltr.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_regulatory_document",
          "documentKind": "regulatory_approval_letter",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-04",
          "reviewedAt": "2026-09-04"
        }
      },
      {
        "date": "2025-09-12",
        "title": {
          "zh": "ANI 当前通用药标签更新",
          "en": "Current ANI generic label update"
        },
        "detail": {
          "zh": "1.25/2.5 mg、100 片瓶装文字与包装面板可公开阅读。",
          "en": "Text and package panels for 1.25/2.5 mg 100-tablet bottles are publicly readable."
        },
        "source": {
          "id": "src_75b816aca5469bf8",
          "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-04",
          "reviewedAt": "2026-09-04"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "美国 LOZOL",
          "en": "United States — LOZOL"
        },
        "status": {
          "zh": "历史原研/RLD，已停市",
          "en": "Historical originator/RLD; discontinued"
        },
        "detail": {
          "zh": "FDA 认定不是因安全性或有效性原因撤回。",
          "en": "FDA determined that withdrawal was not for safety or effectiveness reasons."
        }
      },
      {
        "market": {
          "zh": "美国 ANI 通用药",
          "en": "United States — ANI generic"
        },
        "status": {
          "zh": "当前公开通用药标签",
          "en": "Current public generic label"
        },
        "detail": {
          "zh": "ANDA 074299；1.25/2.5 mg，100 片瓶装。",
          "en": "ANDA 074299; 1.25/2.5 mg in 100-tablet bottles."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "图片里的是 LOZOL 原研包装吗？",
          "en": "Is the pictured pack original LOZOL?"
        },
        "answer": {
          "zh": "不是。图片是 ANI 当前通用药标签；LOZOL 只作为历史原研/RLD 身份展示。",
          "en": "No. The image is a current ANI generic label; LOZOL is shown only as the historical originator/RLD identity."
        }
      },
      {
        "question": {
          "zh": "吲达帕胺和氯噻酮、氢氯噻嗪能按毫克换吗？",
          "en": "Can indapamide be converted by milligrams to chlorthalidone or hydrochlorothiazide?"
        },
        "answer": {
          "zh": "不能由网页或毫克数自行换算。它们是不同药物，作用时程、标签、监测和个体风险不同。",
          "en": "Not by the site or milligram arithmetic. They are different medicines with different duration, labels, monitoring and individual risks."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "dose-unit-literacy",
      "same-class-is-not-same-medicine",
      "interactions-are-not-a-home-scheduling-problem"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/lozol-indapamide/",
    "en": "https://origindrug.com/en/drugs/lozol-indapamide/"
  },
  "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."
  ]
}