{ "id": "monopril-fosinopril", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-13", "status": "published_traceable_archive" }, "names": { "brand": "MONOPRIL", "generic": "福辛普利钠普通口服片", "aliases": [ "Monopril", "fosinopril", "fosinopril sodium", "fosinopril sodium tablets", "福辛普利", "福辛普利钠", "福辛普利钠片", "蒙诺", "MONOPRIL", "NDA 019915", "MONOPRIL 10 mg", "MONOPRIL 20 mg", "MONOPRIL 40 mg" ], "marketBrandNames": [ { "name": "MONOPRIL", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 019915：10/20/40 mg 历史单方口服片均为 RLD，当前均为 DISCN；监管历史不等于实时供应。", "en": "NDA 019915: historical 10/20/40 mg single-ingredient oral tablets are RLD entries and currently DISCN; regulatory history is not live supply." }, "source": { "id": "src_bab1d3663a3c9c1a", "label": "FDA Orange Book：MONOPRIL（福辛普利钠）NDA 019915 的 10/20/40 mg 历史口服片 RLD 条目；当前均为 DISCN，且非因安全性或有效性撤市", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "name": "FOSINOPRIL SODIUM", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "dated_regulatory_record", "note": { "zh": "当前可公开阅读的是 Chartwell RX 仿制药标签；不把它改写成 MONOPRIL 原品牌包装。", "en": "The publicly readable current source is a Chartwell RX generic label; it is not rewritten as an original MONOPRIL pack." }, "source": { "id": "src_71530546861c70f2", "label": "DailyMed（NLM）：福辛普利钠普通口服片当前美国公开仿制药说明书（Chartwell RX；2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff1323cc-7ad8-488d-94a7-a11555db78a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "FDA Orange Book 的 MONOPRIL NDA 019915 历史单方普通口服片为 10、20、40 mg，均列为 DISCN；数据同时说明并非因安全性或有效性撤市。当前公开阅读来源是 Chartwell RX 的仿制药福辛普利钠片标签，不是 MONOPRIL 原品牌包装、实时库存或其他市场状态。", "dosageFormClass": "福辛普利钠普通口服片。MONOPRIL-HCT 另含氢氯噻嗪；单方与复方、福辛普利与其他 ACE 抑制剂不能仅按共同用途或 mg 自行换算、拼接、叠加或替换。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1991（美国 MONOPRIL 初始批准年份）", "archiveSponsorText": "Bristol-Myers Squibb（FDA 历史 NDA/RLD 条目申请主体）；Chartwell RX, LLC（当前公开仿制药标签主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "MONOPRIL", "Monopril", "fosinopril sodium tablets", "福辛普利钠片" ], "excludedProductCues": [ "MONOPRIL-HCT", "fosinopril sodium hydrochlorothiazide", "福辛普利钠氢氯噻嗪", "other ACE inhibitors" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "未展示 MONOPRIL 外观图：历史原研与当前仿制药标签不能混作同一包装", "en": "MONOPRIL image withheld: a historical originator and a current generic label are not one package" }, "summary": { "zh": "本次核验保留了历史 MONOPRIL 的 FDA 产品身份及当前福辛普利钠仿制药公开说明书，但未取得能与 MONOPRIL、特定规格、特定包装和公开一手来源逐一对应的准确外观图。为避免把仿制药、其他市场、历史版本或来源不明图片误作原品牌外观，本页不展示包装图。", "en": "This review retains the historical FDA identity for MONOPRIL and a current public generic fosinopril label, but no exact public image was retained that matches MONOPRIL, one strength, one pack and a primary source one-to-one. To avoid presenting generic, other-market, historical-version or source-uncertain imagery as the originator appearance, this page shows no package image." }, "source": { "id": "src_bab1d3663a3c9c1a", "label": "FDA Orange Book：MONOPRIL（福辛普利钠）NDA 019915 的 10/20/40 mg 历史口服片 RLD 条目；当前均为 DISCN，且非因安全性或有效性撤市", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "福辛普利说明书放大阅读：先分清历史品牌、每片 mg、复方与同类药", "en": "Fosinopril enlarged-label reading: first separate historical brand, per-tablet mg, combinations and class medicines" }, "summary": { "zh": "MONOPRIL 历史 10/20/40 mg 是每片福辛普利钠规格；它不是个人片数，也不能与 MONOPRIL-HCT、其他 ACE 抑制剂或 ARB 按数字自行互换。当前公开说明书属于仿制药，需要与手中药盒的成分、剂型、规格、市场和文件版本逐项核对。", "en": "Historical MONOPRIL 10/20/40 mg figures are fosinopril sodium strengths per tablet. They are not an individual's tablet count and cannot be self-interchanged from numbers with MONOPRIL-HCT, another ACE inhibitor or an ARB. The current public leaflet is generic and must be checked item by item against the pack in hand for ingredient, form, strength, market and document version." }, "checks": [ { "zh": "ACE 抑制剂标签有胎儿毒性警示。已怀孕、可能怀孕或计划怀孕时，应立即联系开方团队；网页不生成继续、暂停或替代方案。", "en": "ACE-inhibitor labels carry a fetal-toxicity warning. Contact the prescriber promptly for pregnancy, possible pregnancy or pregnancy planning; this site creates no continuation, stopping or replacement plan." }, { "zh": "面、唇、舌或喉咙肿胀，尤其伴呼吸或吞咽困难，属于需要紧急处理的血管性水肿信号；不要等待网页判断。", "en": "Swelling of the face, lips, tongue or throat—especially with breathing or swallowing difficulty—is an emergency angioedema signal. Do not wait for a website assessment." }, { "zh": "补钾、含钾代盐、保钾利尿药、另一种 ACEI/ARB、NSAID、锂或利尿剂同处药单时，应优先核对血钾、肾功能、低血压与跌倒风险；发现疑似重复时不要自行增减、错开或停药。", "en": "Potassium supplements or salt substitutes, a potassium-sparing diuretic, another ACE inhibitor/ARB, NSAID, lithium or a diuretic on the same list requires priority review of potassium, kidney function, hypotension and fall risk. Do not self-add, reduce, separate or stop when duplication is suspected." } ], "source": { "id": "src_71530546861c70f2", "label": "DailyMed（NLM）：福辛普利钠普通口服片当前美国公开仿制药说明书（Chartwell RX；2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff1323cc-7ad8-488d-94a7-a11555db78a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "福辛普利怎样起作用：ACE 抑制与血管紧张素 II／缓激肽通路", "en": "How fosinopril works: ACE inhibition and the angiotensin II/bradykinin pathways" }, "summary": { "zh": "福辛普利在体内转化为有活性的福辛普利拉；ACE 抑制会减少血管紧张素 II 形成并影响醛固酮相关通路。ACE 也参与缓激肽分解，这有助于理解咳嗽和血管性水肿为何需要认真识别；机制不能替个人选择药物或剂量。", "en": "Fosinopril is converted in the body to active fosinoprilat. ACE inhibition reduces angiotensin II formation and affects aldosterone-related pathways. ACE also participates in bradykinin breakdown, which helps explain why cough and angioedema require attention; mechanism cannot choose a medicine or dose for an individual." }, "checks": [ { "zh": "MONOPRIL、LOTENSIN、ZESTRIL、VASOTEC、ALTACE、CAPOTEN 与 COVERSYL 不是同一种药；共同 ACE 抑制机制不建立 mg 换算、轮换或叠加规则。", "en": "MONOPRIL, LOTENSIN, ZESTRIL, VASOTEC, ALTACE, CAPOTEN and COVERSYL are not one medicine. A shared ACE-inhibitor mechanism does not establish milligram conversion, alternation or combination." }, { "zh": "另一种肾素-血管紧张素系统药物同处药单时，可能增加低血压、高钾和肾功能受损风险；共同机制不是更强或更适合的证明。", "en": "Another renin-angiotensin-system medicine on the same list can increase risks of hypotension, hyperkalaemia and kidney impairment. A shared mechanism is not proof of greater benefit or suitability." }, { "zh": "干咳可以与 ACE 抑制剂有关，但呼吸困难、喉头紧、面唇舌肿胀不能简单当作普通咳嗽，应按紧急信号处理。", "en": "A dry cough can be associated with ACE inhibitors, but breathing difficulty, throat tightness or face/lip/tongue swelling must not be dismissed as an ordinary cough and needs emergency action." } ], "source": { "id": "src_71530546861c70f2", "label": "DailyMed（NLM）：福辛普利钠普通口服片当前美国公开仿制药说明书（Chartwell RX；2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff1323cc-7ad8-488d-94a7-a11555db78a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MONOPRIL", "generic": "福辛普利钠普通口服片", "dosageFormClass": "福辛普利钠普通口服片。MONOPRIL-HCT 另含氢氯噻嗪；单方与复方、福辛普利与其他 ACE 抑制剂不能仅按共同用途或 mg 自行换算、拼接、叠加或替换。" }, "labelSource": { "id": "src_71530546861c70f2", "label": "DailyMed（NLM）：福辛普利钠普通口服片当前美国公开仿制药说明书（Chartwell RX；2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff1323cc-7ad8-488d-94a7-a11555db78a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "productRoutes": [ { "source": { "id": "src_71530546861c70f2", "label": "DailyMed（NLM）：福辛普利钠普通口服片当前美国公开仿制药说明书（Chartwell RX；2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff1323cc-7ad8-488d-94a7-a11555db78a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "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": "2026-09-13", "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": "2026-09-13", "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": "MONOPRIL 是福辛普利钠单方普通口服片的历史美国原研档案。10、20、40 mg 是每片历史标签规格，不是个人片数、减量表或与其他降压药的换算比例。老人和多药使用者应优先让药师或开方团队核对完整药单、血压相关症状、肾功能、血钾、利尿剂、补钾或含钾代盐、NSAID 止痛药、锂、其他 ACEI/ARB 及含沙库巴曲的产品；网页不决定个人剂量、频次、停药或换药。", "history": "FDA Orange Book 记录 MONOPRIL NDA 019915 的 10 mg 与 20 mg 片于 1991 年获批、40 mg 片于 1995 年获批。三个历史 RLD 条目当前均为 DISCN，且记录为非因安全性或有效性撤市。本站仅用当前公开仿制药标签帮助阅读福辛普利钠的药物类别与警戒边界，不把它当作历史 MONOPRIL 品牌的准确包装或供应证明。", "sourceDocuments": [ { "id": "src_bab1d3663a3c9c1a", "label": "FDA Orange Book：MONOPRIL（福辛普利钠）NDA 019915 的 10/20/40 mg 历史口服片 RLD 条目；当前均为 DISCN，且非因安全性或有效性撤市", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_71530546861c70f2", "label": "DailyMed（NLM）：福辛普利钠普通口服片当前美国公开仿制药说明书（Chartwell RX；2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff1323cc-7ad8-488d-94a7-a11555db78a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } ], "applicationNumber": "NDA 019915（MONOPRIL 历史美国单方产品）；当前公开仿制药标签：DailyMed SETID ff1323cc-7ad8-488d-94a7-a11555db78a7", "approvalTimeline": [ { "date": "1991-05-16", "title": { "zh": "MONOPRIL 10 mg 与 20 mg 美国批准", "en": "U.S. approval of MONOPRIL 10 mg and 20 mg" }, "detail": { "zh": "FDA Orange Book 中 NDA 019915 的两个历史单方口服片 RLD 条目。", "en": "Two historical single-ingredient oral-tablet RLD entries under FDA NDA 019915." }, "source": { "id": "src_bab1d3663a3c9c1a", "label": "FDA Orange Book：MONOPRIL（福辛普利钠）NDA 019915 的 10/20/40 mg 历史口服片 RLD 条目；当前均为 DISCN，且非因安全性或有效性撤市", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "1995-03-28", "title": { "zh": "MONOPRIL 40 mg 美国批准", "en": "U.S. approval of MONOPRIL 40 mg" }, "detail": { "zh": "FDA Orange Book 中 NDA 019915 的第三个历史单方口服片 RLD 条目。", "en": "The third historical single-ingredient oral-tablet RLD entry under FDA NDA 019915." }, "source": { "id": "src_bab1d3663a3c9c1a", "label": "FDA Orange Book：MONOPRIL（福辛普利钠）NDA 019915 的 10/20/40 mg 历史口服片 RLD 条目；当前均为 DISCN，且非因安全性或有效性撤市", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "2025-11-17", "title": { "zh": "现行公开仿制药说明书发布", "en": "Current public generic label published" }, "detail": { "zh": "Chartwell RX 福辛普利钠片说明书用于阅读现行安全与类别信息，不替代历史 MONOPRIL 包装资料。", "en": "The Chartwell RX fosinopril sodium label supports reading current safety and class information; it does not replace historical MONOPRIL pack evidence." }, "source": { "id": "src_71530546861c70f2", "label": "DailyMed（NLM）：福辛普利钠普通口服片当前美国公开仿制药说明书（Chartwell RX；2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff1323cc-7ad8-488d-94a7-a11555db78a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史 RLD；当前 DISCN", "en": "Historical RLD; currently DISCN" }, "detail": { "zh": "MONOPRIL 10/20/40 mg 的 FDA 历史 RLD 条目均列为 DISCN，且不是因安全性或有效性撤市；不代表实时供应。", "en": "FDA historical RLD entries for MONOPRIL 10/20/40 mg are all DISCN and not withdrawn for safety or effectiveness; this is not live-supply evidence." } }, { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开仿制药标签", "en": "Current public generic label" }, "detail": { "zh": "公开说明书为 Chartwell RX 福辛普利钠片；必须按实际包装、NDC 与标签版本确认。", "en": "The public leaflet is for Chartwell RX fosinopril sodium tablets and must be checked against the actual pack, NDC and label version." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "当地商品名、批准、包装和供应未由本档案确认", "en": "Local brand, approval, pack and supply are not established by this dossier" }, "detail": { "zh": "不从美国历史 RLD 或仿制药标签外推其他市场状态。", "en": "No other-market status is inferred from the U.S. historical RLD or generic label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "MONOPRIL 与 MONOPRIL-HCT 是一回事吗？", "en": "Are MONOPRIL and MONOPRIL-HCT the same product?" }, "answer": { "zh": "不是。MONOPRIL 是福辛普利钠单方；MONOPRIL-HCT 另含氢氯噻嗪。共同名称不能作为自行叠加、替换或换算依据。", "en": "No. MONOPRIL is fosinopril sodium alone, whereas MONOPRIL-HCT also contains hydrochlorothiazide. A shared name is not a basis for self-combination, substitution or conversion." } }, { "question": { "zh": "历史 10/20/40 mg 是否等于我该吃几片？", "en": "Do historical 10/20/40 mg strengths tell me how many tablets to take?" }, "answer": { "zh": "不等于。它们只是历史产品的每片规格。个人片数、频次、肾功能、合并用药和是否需要调整必须由开方团队依据实际药盒、处方、检查结果和完整药单决定。", "en": "No. They are only per-tablet strengths for historical products. Individual tablet counts, frequency, kidney function, co-medications and any adjustment must be decided by the prescribing team using the actual pack, prescription, test results and complete medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/monopril-fosinopril/", "en": "https://origindrug.com/en/drugs/monopril-fosinopril/" }, "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." ] }