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This page does not display an original-brand pack." }, "source": { "id": "src_c1df715dc8b77961", "label": "FDA：HYGROTON（chlorthalidone）NDA 012283 原研/RLD 历史与停市原因边界（NDA 218647 临床药理审评）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/218647Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "name": "chlorthalidone", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "Mylan ANDA 086831 当前通用药标签；25/50 mg 的 100 片与 1000 片瓶装。监管标签不等于实时库存。", "en": "Current Mylan generic label under ANDA 086831; 25/50 mg in 100- and 1000-tablet bottles. A regulatory label is not live stock." }, "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "FDA 审评文件将 HYGROTON（NDA 012283）列为氯噻酮历史原研/RLD，并说明其停市并非出于安全性或有效性原因。当前准确包装来自 Mylan ANDA 086831 通用药标签：25 mg 与 50 mg，每种均有 100 片和 1000 片瓶装；只有两个 100 片面板有本页展示的准确公开图片。历史品牌、当前通用药和其他市场供应不得混写。", "dosageFormClass": "氯噻酮普通口服片。HYGROTON 历史原研、Mylan 当前通用药、HEMICLOR 12.5 mg 及含氯噻酮复方是不同监管产品；共同成分不建立包装、强度、片数或替换结论。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1960（HYGROTON 美国初始批准年份）", "archiveSponsorText": "HYGROTON 历史原研/RLD；Mylan Pharmaceuticals Inc.／Viatris 为当前展示通用药标签方" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "HYGROTON", "chlorthalidone", "chlorthalidone tablets", "氯噻酮", "氯噻酮片" ], "excludedProductCues": [ "HEMICLOR", "chlorthalidone 12.5 mg", "HYGROTON RESERPINE", "hydrochlorothiazide", "氢氯噻嗪", "indapamide", "吲达帕胺" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-chlorthalidone-25mg-100-tablet-bottle-ndc-0378022201", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026-04-02 修订）", "en": "Current U.S. DailyMed generic label (revised 2 Apr 2026)" }, "dosageForm": { "zh": "氯噻酮普通口服片", "en": "chlorthalidone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0378-0222-01", "pouchCode": null, "applicationNumber": "ANDA 086831", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯噻酮 25 mg；100 片瓶装", "en": "25 mg chlorthalidone per tablet; 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100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=15dd224a-87ad-48dc-80b1-e8382a452c4c&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯噻酮", "en": "chlorthalidone" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用频次，也不是与氢氯噻嗪、吲达帕胺或其他利尿药的换算值", "en": "labelled amount per tablet; not an individual's tablet count or frequency, or a conversion to hydrochlorothiazide, indapamide or 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": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅绿色", "en": "light green" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "M / 75", "scoreStatus": "scored_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-chlorthalidone-50mg-1000-tablet-bottle-ndc-0378021310", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026-04-02 修订）", "en": "Current U.S. DailyMed generic label (revised 2 Apr 2026)" }, "dosageForm": { "zh": "氯噻酮普通口服片", "en": "chlorthalidone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0378-0213-10", "pouchCode": null, "applicationNumber": "ANDA 086831", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯噻酮 50 mg；1000 片瓶装", "en": "50 mg chlorthalidone per tablet; 1000-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯噻酮", "en": "chlorthalidone" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用频次，也不是与氢氯噻嗪、吲达帕胺或其他利尿药的换算值", "en": "labelled amount per tablet; not an individual's tablet count or frequency, or a conversion to hydrochlorothiazide, indapamide or another diuretic" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅绿色", "en": "light green" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "M / 75", "scoreStatus": "scored_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-chlorthalidone-25mg-100-tablet-bottle-ndc-0378022201", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&setid=15dd224a-87ad-48dc-80b1-e8382a452c4c&type=img", "alt": "Mylan/Viatris 氯噻酮 25 mg、NDC 0378-0222-01、100 片瓶装的 DailyMed 官方通用药标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国通用药标签（2026-04）", "presentation": "25 mg：浅黄色圆片、M35、无刻痕；NDC 0378-0222-01，100 片瓶装。另有 50 mg 浅绿色 M/75 有刻痕、NDC 0378-0213-01 的准确 100 片面板。", "notice": "此图是 Mylan/Viatris 当前通用药包装标签，不是 HYGROTON 原品牌包装；只对应 NDC 0378-0222-01，不代表 50 mg、1000 片瓶装、HEMICLOR、复方或其他市场供应，也不用于鉴定真伪。", "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "氯噻酮说明书放大阅读：分清历史 HYGROTON、当前通用药、每片 mg 与整瓶片数", "en": "Chlorthalidone enlarged label: separate historical HYGROTON, the current generic, per-tablet mg and bottle count" }, "summary": { "zh": "25 mg 与 50 mg 是每片氯噻酮含量；100/1000 Tablets 是整瓶片数。50 mg 药片有刻痕，但刻痕只属于准确产品外观，不能自动变成任何人的掰片、加减量或换药许可。", "en": "The 25 mg and 50 mg figures are chlorthalidone per tablet; 100/1000 Tablets are bottle counts. The 50 mg tablet is scored, but a score is an exact-product appearance feature—not automatic permission for anyone to split, change an amount or switch medicines." }, "checks": [ { "zh": "利尿会影响水分与电解质。口渴、口干、乏力、嗜睡、肌肉痛/痉挛、恶心、心跳异常、意识或步态变化，都应结合钠、钾、镁、肾功能和完整药单及时核对；严重症状或昏厥使用当地急救。", "en": "Diuresis can affect fluid and electrolytes. Thirst, dry mouth, weakness, somnolence, muscle pain/cramps, nausea, an abnormal heartbeat, or changes in awareness or gait require timely review with sodium, potassium, magnesium, kidney function and the complete medicine list. Use local emergency care for severe symptoms or fainting." }, { "zh": "老人、进食饮水减少、呕吐腹泻、发热或同时使用其他降压/利尿药时，更容易出现容量不足、站立性头晕、低血压和跌倒；不要据家庭血压或水肿自行停、加、减或隔天轮换。", "en": "Older age, reduced food or fluid intake, vomiting/diarrhoea, fever, or another blood-pressure/diuretic medicine can increase volume depletion, orthostatic dizziness, hypotension and falls. Do not self-stop, increase, reduce or alternate from home blood pressure or oedema alone." }, { "zh": "标签要求关注肾功能、肝病、尿酸/痛风、血糖与脂质变化。无尿是禁忌；严重肾病或肝病必须由负责治疗的专业人员评估，网页不从化验值生成方案。", "en": "The label calls for attention to kidney function, liver disease, uric acid/gout, glucose and lipid changes. Anuria is contraindicated; severe kidney or liver disease requires treating-professional assessment, and the site does not generate a plan from laboratory values." }, { "zh": "地高辛、锂、NSAID 止痛药、糖皮质激素、促皮质激素、其他利尿剂或降压药同处药单时，应优先核对电解质、肾功能、血压和药物浓度风险；不要自行错开或删除其中一盒。", "en": "Digoxin, lithium, an NSAID pain medicine, a corticosteroid, ACTH, another diuretic or blood-pressure medicine on the same list requires priority review of electrolytes, kidney function, blood pressure and concentration-related risk. Do not self-space or remove a pack." } ], "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "氯噻酮怎样利尿降压：减少远端肾小管钠氯重吸收，不等于所有利尿药可以按 mg 换", "en": "How chlorthalidone causes diuresis and lowers pressure: reduced distal tubular sodium-chloride reabsorption does not make diuretics milligram-interchangeable" }, "summary": { "zh": "FDA 药理审评将氯噻酮描述为噻嗪样、磺酰胺衍生利尿药，其作用与拮抗远端肾小管钠氯同向转运有关。机制可解释水分、电解质与血压变化，但不能决定个人适用性、片数、时间、补钾或与其他药联用。", "en": "FDA pharmacology review describes chlorthalidone as a thiazide-like, sulfonamide-derived diuretic acting through antagonism of the distal tubular sodium-chloride cotransporter. The mechanism helps explain fluid, electrolyte and blood-pressure effects but cannot determine individual suitability, tablet count, timing, potassium use or combination therapy." }, "checks": [ { "zh": "氯噻酮、氢氯噻嗪、吲达帕胺、呋塞米、螺内酯和依普利酮不是同一种药；共同“利尿”用途不建立 mg 换算、轮换或叠加规则。", "en": "Chlorthalidone, hydrochlorothiazide, indapamide, furosemide, spironolactone and eplerenone are not one medicine. A shared diuretic purpose does not establish milligram conversion, alternation or combination." }, { "zh": "低钾不表示人人都应自行补钾；补钾、含钾代盐、ACEI/ARB/ARNI 或保钾利尿药可能改变另一方向的风险，必须结合化验和完整药单核对。", "en": "A low-potassium risk does not mean everyone should self-supplement. Potassium, potassium-containing salt substitutes, an ACE inhibitor/ARB/ARNI or a potassium-sparing diuretic can change risk in the opposite direction and requires laboratory and full-list review." }, { "zh": "排尿增多、体重或水肿变化不是个人服药方案。老人若出现明显乏力、意识变化、跌倒、心悸或无法进食饮水，应及时联系治疗团队，严重时使用急救。", "en": "More urination, weight change or oedema change is not an individual regimen. Marked weakness, altered awareness, a fall, palpitations or inability to eat or drink in an older adult needs prompt treating-team review and emergency care when severe." } ], "source": { "id": "src_b747da6d9fec0a51", "label": "FDA：氯噻酮药理、HYGROTON NDA 012283 与 Mylan ANDA 086831 桥接审评（NDA 218647）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/218647Orig1s000PharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "HYGROTON / chlorthalidone", "generic": "氯噻酮普通片", "dosageFormClass": "氯噻酮普通口服片。HYGROTON 历史原研、Mylan 当前通用药、HEMICLOR 12.5 mg 及含氯噻酮复方是不同监管产品；共同成分不建立包装、强度、片数或替换结论。" }, "labelSource": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "HYGROTON 是氯噻酮的历史原研/RLD；本页可见的粉红/绿色标签面板是当前 Mylan/Viatris 通用药，不是原品牌包装。25/50 mg 是每片含量，100 或 1000 Tablets 是整瓶片数。老人和多药使用者应优先核对脱水、站立性头晕/跌倒、钠钾镁、肾功能、尿酸/痛风、血糖，以及地高辛、锂、NSAID、其他利尿剂与降压药；网页不生成个人片数或换药比例。", "history": "氯噻酮于 1960 年以 HYGROTON 在美国获批。FDA 2026 年 NDA 218647 审评回顾 HYGROTON NDA 012283，说明其后来停市并非出于安全性或有效性原因，并将 Mylan ANDA 086831 的 50 mg 产品列为参考标准。当前 DailyMed 通用药标签于 2026-04 修订，不能被描述为原品牌包装。", "sourceDocuments": [ { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_c1df715dc8b77961", "label": "FDA：HYGROTON（chlorthalidone）NDA 012283 原研/RLD 历史与停市原因边界（NDA 218647 临床药理审评）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/218647Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_b747da6d9fec0a51", "label": "FDA：氯噻酮药理、HYGROTON NDA 012283 与 Mylan ANDA 086831 桥接审评（NDA 218647）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/218647Orig1s000PharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "HYGROTON NDA 012283（历史原研/RLD）；Mylan chlorthalidone ANDA 086831（当前通用药标签）", "approvalTimeline": [ { "date": "1960", "title": { "zh": "HYGROTON 在美国初始批准", "en": "Initial U.S. approval of HYGROTON" }, "detail": { "zh": "FDA 审评文件记载氯噻酮于 1960 年初始获批，并把 HYGROTON NDA 012283 列为历史原研/RLD。", "en": "FDA review records chlorthalidone's initial approval in 1960 and identifies HYGROTON NDA 012283 as the historical originator/RLD." }, "source": { "id": "src_c1df715dc8b77961", "label": "FDA：HYGROTON（chlorthalidone）NDA 012283 原研/RLD 历史与停市原因边界（NDA 218647 临床药理审评）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/218647Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2024-05-03", "title": { "zh": "FDA 审评明确历史原研停市与参考标准边界", "en": "FDA review clarified the discontinued originator and reference-standard boundary" }, "detail": { "zh": "审评说明 HYGROTON 已停市且并非安全性或有效性原因，并把 Mylan ANDA 086831 的 50 mg 氯噻酮列为参考标准。", "en": "The review states that HYGROTON was discontinued for reasons other than safety or efficacy and identifies Mylan chlorthalidone 50 mg under ANDA 086831 as the reference standard." }, "source": { "id": "src_c1df715dc8b77961", "label": "FDA：HYGROTON（chlorthalidone）NDA 012283 原研/RLD 历史与停市原因边界（NDA 218647 临床药理审评）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/218647Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2026-04-02", "title": { "zh": "当前 Mylan 通用药标签修订", "en": "Current Mylan generic label revision" }, "detail": { "zh": "当前 25/50 mg、100/1000 片瓶装文字及两个 100 片包装面板可公开阅读。", "en": "Current 25/50 mg, 100/1000-tablet bottle text and two 100-tablet package panels are publicly readable." }, "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国 HYGROTON", "en": "United States — HYGROTON" }, "status": { "zh": "历史原研/RLD，已停市", "en": "Historical originator/RLD; discontinued" }, "detail": { "zh": "NDA 012283；FDA 审评说明停市并非安全性或有效性原因。", "en": "NDA 012283; FDA review states that discontinuation was not for safety or efficacy reasons." } }, { "market": { "zh": "美国 Mylan 通用药", "en": "United States — Mylan generic" }, "status": { "zh": "当前公开通用药标签", "en": "Current public generic label" }, "detail": { "zh": "ANDA 086831；25/50 mg，100/1000 片瓶装。", "en": "ANDA 086831; 25/50 mg in 100- and 1000-tablet bottles." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地品牌、规格、包装或供应", "en": "Local brand, strength, pack and supply are not established" }, "detail": { "zh": "必须按当地药监记录、现行说明书和手中药盒逐项核对。", "en": "Check the local regulator, current label and pack in hand item by item." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "照片里的是 HYGROTON 原研药盒吗？", "en": "Is the pictured pack the original HYGROTON pack?" }, "answer": { "zh": "不是。照片是 Mylan/Viatris 当前通用药 25 mg 或 50 mg 的包装标签；HYGROTON 只作为历史原研/RLD 身份展示，本页没有把通用药图片冒充原品牌外观。", "en": "No. The images are current Mylan/Viatris generic 25 mg or 50 mg package labels. HYGROTON is shown only as the historical originator/RLD identity; the page does not present a generic image as original-brand appearance." } }, { "question": { "zh": "50 mg 有刻痕，是不是能掰半当 25 mg？", "en": "The 50 mg tablet is scored. Can it be halved to make 25 mg?" }, "answer": { "zh": "不能由刻痕或算术自行决定。25 mg 与 50 mg 是不同准确产品；分片还涉及处方、产品标签、均一性、个人情况和药师确认。网页只记录刻痕，不生成掰片许可。", "en": "Not from a score or arithmetic alone. The 25 mg and 50 mg are distinct exact products, and splitting depends on the prescription, product label, uniformity, individual context and pharmacist review. The site records the score but does not issue splitting permission." } }, { "question": { "zh": "氯噻酮和氢氯噻嗪、呋塞米可以换着吃或一起吃吗？", "en": "Can chlorthalidone, hydrochlorothiazide or furosemide be alternated or combined?" }, "answer": { "zh": "网页不能这样决定。它们不是同一种药，作用强度、时程、适应证和电解质/肾功能风险不同；可能存在专业人员安排的联用，也可能造成重复或伤害，必须用准确药盒、化验、血压和完整药单核对。", "en": "The site cannot make that decision. They are different medicines with different potency, duration, indications and electrolyte/kidney risks. Professional combination may exist, but duplication or harm is also possible; exact packs, laboratory results, blood pressure and the complete list require review." } } ], "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/hygroton-chlorthalidone/", "en": "https://origindrug.com/en/drugs/hygroton-chlorthalidone/" }, "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." ] }