{ "id": "vasotec", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "VASOTEC", "generic": "依那普利", "aliases": [ "VASOTEC", "enalapril", "enalapril maleate", "依那普利", "马来酸依那普利", "NDA 018998", "VASO 2.5", "VASO 5", "VASO 10", "VASO 20", "018998" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 VASOTEC（enalapril maleate）NDA 018998 原品牌监管历史与 DailyMed 2026-01-23 当前公开标签", "dosageFormClass": "VASOTEC 马来酸依那普利口服刻痕片：2.5、5、10、20 mg；所引当前美国标签另含药师配制 1 mg/mL 混悬液的专业说明，但本档案不把该段转换成家庭配制或个人用量指令", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1985-12-24（FDA NDA 018998 原始批准）", "archiveSponsorText": "Merck Sharp & Dohme 原始申请历史；DailyMed 当前标签列示 Bausch Health US LLC；持有人、供应和其他市场状态须按现行监管记录另行核验" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "enalaprilat injection", "VASOTEC I.V.", "VASERETIC", "enalapril and hydrochlorothiazide", "依那普利氢氯噻嗪", "复方依那普利" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-vasotec-enalapril-maleate-2-5mg-30-tablet-bottle-ndc-0187014030", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v15（2026-01-23 生效）", "en": "DailyMed SPL v15 (effective 23 Jan 2026)" }, "dosageForm": { "zh": "VASOTEC 马来酸依那普利刻痕口服片", "en": "VASOTEC enalapril maleate scored oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0140-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片马来酸依那普利 2.5 mg；NDC 0187-0140-30；30 片瓶装", "en": "Enalapril maleate 2.5 mg per tablet; NDC 0187-0140-30; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-01.jpg&setid=39631f1f-5d19-43c1-b504-bf56d991ed97&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "马来酸依那普利", "en": "enalapril maleate" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形；有刻痕（外观线索不是个人掰片许可）", "en": "oval; scored (an appearance clue, not personal permission to split)" }, "imprint": "VASO 2.5", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利 2.5 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vasotec-enalapril-maleate-5mg-30-tablet-bottle-ndc-0187014130", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v15（2026-01-23 生效）", "en": "DailyMed SPL v15 (effective 23 Jan 2026)" }, "dosageForm": { "zh": "VASOTEC 马来酸依那普利刻痕口服片", "en": "VASOTEC enalapril maleate scored oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0141-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片马来酸依那普利 5 mg；NDC 0187-0141-30；30 片瓶装", "en": "Enalapril maleate 5 mg per tablet; NDC 0187-0141-30; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&setid=39631f1f-5d19-43c1-b504-bf56d991ed97&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "马来酸依那普利", "en": "enalapril maleate" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆角三角形；有刻痕（外观线索不是个人掰片许可）", "en": "rounded triangular; scored (an appearance clue, not personal permission to split)" }, "imprint": "VASO 5", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利 5 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vasotec-enalapril-maleate-10mg-30-tablet-bottle-ndc-0187014230", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v15（2026-01-23 生效）", "en": "DailyMed SPL v15 (effective 23 Jan 2026)" }, "dosageForm": { "zh": "VASOTEC 马来酸依那普利刻痕口服片", "en": "VASOTEC enalapril maleate scored oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0142-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片马来酸依那普利 10 mg；NDC 0187-0142-30；30 片瓶装", "en": "Enalapril maleate 10 mg per tablet; NDC 0187-0142-30; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=39631f1f-5d19-43c1-b504-bf56d991ed97&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "马来酸依那普利", "en": "enalapril maleate" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "铁锈红色", "en": "rust red" }, "shape": { "zh": "圆角三角形；有刻痕（外观线索不是个人掰片许可）", "en": "rounded triangular; scored (an appearance clue, not personal permission to split)" }, "imprint": "VASO 10", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利 10 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vasotec-enalapril-maleate-20mg-30-tablet-bottle-ndc-0187014330", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v15（2026-01-23 生效）", "en": "DailyMed SPL v15 (effective 23 Jan 2026)" }, "dosageForm": { "zh": "VASOTEC 马来酸依那普利刻痕口服片", "en": "VASOTEC enalapril maleate scored oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0143-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片马来酸依那普利 20 mg；NDC 0187-0143-30；30 片瓶装", "en": "Enalapril maleate 20 mg per tablet; NDC 0187-0143-30; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=39631f1f-5d19-43c1-b504-bf56d991ed97&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "马来酸依那普利", "en": "enalapril maleate" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "圆角三角形；有刻痕（外观线索不是个人掰片许可）", "en": "rounded triangular; scored (an appearance clue, not personal permission to split)" }, "imprint": "VASO 20", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利 20 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-vasotec-enalapril-maleate-10mg-30-tablet-bottle-ndc-0187014230", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=39631f1f-5d19-43c1-b504-bf56d991ed97&type=img", "alt": "VASOTEC 马来酸依那普利在美国 DailyMed 当前标签中的 10 mg、NDC 0187-0142-30、30 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v15（2026-01-23 生效）", "presentation": "VASOTEC 马来酸依那普利：每片 10 mg，NDC 0187-0142-30，30 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 VASOTEC、马来酸依那普利 10 mg、NDC 0187-0142-30 与 30 片瓶装。它只帮助核对商品名、通用名、每片标示量、片剂、包装数量、VASO 10 刻印与来源；不用于鉴定真伪，也不证明 2.5/5/20 mg、90/1,000 片包装、配制混悬液、其他市场、实时库存、原研身份、可替代性，或任何个人的片数、频率、掰片、停药、联用或换药方案。", "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利 10 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VASOTEC／依那普利说明书放大阅读：先看每片毫克数，再核对整张药单", "en": "VASOTEC/enalapril label reading: check milligrams per tablet, then review the whole medicine list" }, "summary": { "zh": "当前美国标签把 VASOTEC 列为马来酸依那普利 2.5、5、10、20 mg 刻痕片。mg 是每片标示量，不是网页给出的个人片数；刻痕、同属降压药或相近毫克数也不能建立自行掰片、叠加、隔日轮换或换药。", "en": "The current U.S. label lists VASOTEC as scored enalapril maleate tablets in 2.5, 5, 10 and 20 mg strengths. mg is the labelled amount per tablet, not a personal tablet count generated by the site; a score, shared blood-pressure purpose or nearby milligram number does not establish self-splitting, combining, alternate-day use or switching." }, "checks": [ { "zh": "先同时核对 VASOTEC、马来酸依那普利、口服片、2.5/5/10/20 mg、NDC、刻印和目标市场。不要把依那普利注射剂、依那普利/氢氯噻嗪复方、赖诺普利、卡托普利或沙坦类当成同一盒药。", "en": "Check VASOTEC, enalapril maleate, oral tablet, 2.5/5/10/20 mg, NDC, imprint and target market together. Do not treat enalaprilat injection, an enalapril/hydrochlorothiazide combination, lisinopril, captopril or an ARB as the same product." }, { "zh": "2.5、5、10、20 mg 都表示每片标示量；个人用量还要结合处方、血压、肾功能、钾、年龄、脱水情况和其他药物，网页不能把一个规格换算成几片或一日总量。", "en": "2.5, 5, 10 and 20 mg each state a labelled amount per tablet. Individual use also depends on the prescription, blood pressure, kidney function, potassium, age, volume status and other medicines; the site cannot convert a strength into a tablet count or daily total." }, { "zh": "标签写有刻痕并不等于任何人都应掰开，也不表示另一厂家依那普利片的刻痕用途相同。先核对手中准确产品、处方和现行说明书，再请药师或开方团队确认。", "en": "A score in the label does not mean everyone should split the tablet or that another manufacturer's enalapril score has the same purpose. Check the exact product, prescription and current label in hand, then confirm with a pharmacist or prescriber." }, { "zh": "把利尿药、补钾、含钾盐替代品、布洛芬/萘普生等 NSAIDs、锂、其他 ACE 抑制剂、沙坦类和沙库巴曲/缬沙坦放在同一张药单里复核。不要自行叠加、错开、隔日轮换、停用或替换。", "en": "Place diuretics, potassium supplements, potassium-containing salt substitutes, NSAIDs such as ibuprofen/naproxen, lithium, other ACE inhibitors, ARBs and sacubitril/valsartan on one list for review. Do not self-combine, separate, alternate by day, stop or substitute." }, { "zh": "面部、嘴唇、舌头或喉部肿胀，呼吸或吞咽困难，昏厥或其他严重急性问题需要立即使用当地急救服务；不要等待网页判断。怀孕或可能怀孕也应尽快联系开方团队，因为美国标签含胎儿毒性加框警示。", "en": "Swelling of the face, lips, tongue or throat, breathing or swallowing difficulty, fainting or another severe acute problem requires immediate local emergency help; do not wait for a website decision. Pregnancy or possible pregnancy also requires prompt contact with the prescribing team because the U.S. label carries a boxed warning for fetal toxicity." } ], "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利当前美国公开标签（Bausch Health；SPL v15）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "依那普利怎样起作用：前体药转化为依那普利拉，再抑制 ACE", "en": "How enalapril works: a prodrug converted to enalaprilat, then ACE inhibition" }, "summary": { "zh": "当前标签说明依那普利是前体药，口服后水解为活性 ACE 抑制剂依那普利拉。抑制 ACE 会减少血管紧张素 II 的形成和醛固酮分泌，帮助理解血压、肾功能、钾与相互作用为何要一起监测；它不能预测个人反应或决定用量。", "en": "The current label explains that enalapril is a prodrug hydrolysed after oral use to the active ACE inhibitor enalaprilat. ACE inhibition reduces formation of angiotensin II and aldosterone secretion, helping explain why blood pressure, kidney function, potassium and interactions are reviewed together; it cannot predict individual response or determine an amount." }, "checks": [ { "zh": "同属 ACE 抑制剂不表示依那普利可与卡托普利或赖诺普利自行合用、按毫克换算或隔日轮换；与沙坦类或沙库巴曲/缬沙坦也必须按准确药物和现行标签逐项核对。", "en": "Sharing the ACE-inhibitor class does not make enalapril self-combinable, milligram-convertible or alternate-day interchangeable with captopril or lisinopril; ARBs and sacubitril/valsartan also require exact medicine- and current-label review." }, { "zh": "干咳、头晕、乏力、排尿变化或检查异常不能仅凭机制归因，也不能成为自行停药、补服或改用另一种降压药的理由；请带实际药盒和完整药单联系专业人员。", "en": "Dry cough, dizziness, weakness, urine change or an abnormal test cannot be attributed from mechanism alone and is not a reason to self-stop, redose or change to another blood-pressure medicine; take the actual pack and complete medicine list to a professional." }, { "zh": "机制词不能替代血压、肾功能、电解质、妊娠状态和完整药单的临床判断；若有面舌喉肿胀、呼吸困难、昏厥或其他严重急性问题，应立即使用当地急救支持。", "en": "Mechanism terms do not replace clinical review of blood pressure, kidney function, electrolytes, pregnancy status and the complete medicine list. Face/tongue/throat swelling, breathing difficulty, fainting or another severe acute problem requires immediate local emergency support." } ], "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 当前美国公开标签（临床药理与作用机制）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "VASOTEC", "generic": "依那普利", "dosageFormClass": "VASOTEC 马来酸依那普利口服刻痕片：2.5、5、10、20 mg；所引当前美国标签另含药师配制 1 mg/mL 混悬液的专业说明，但本档案不把该段转换成家庭配制或个人用量指令" }, "labelSource": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利当前美国公开标签（Bausch Health；SPL v15，2026-01-23 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利当前美国公开标签（Bausch Health；SPL v15，2026-01-23 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "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_17772ae97ea9f6ad", "label": "FDA Drugs@FDA：VASOTEC（enalapril maleate）NDA 018998 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018998", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "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": "VASOTEC 是马来酸依那普利的美国原品牌档案。当前美国公开标签列出 2.5、5、10、20 mg 四种口服刻痕片，并附准确 NDC、片剂颜色/形状/刻印和瓶装展示面。页面优先帮助老人分清品牌、通用名、每片毫克数、ACE 抑制剂与复方药，理解咳嗽、高钾、肾功能、低血压和血管性水肿等标签警示；不生成个人片数、频率、掰片、停药、联用或换药方案。", "history": "FDA 资料将 VASOTEC 的片剂原始批准日期记录为 1985-12-24，申请号为 NDA 018998。DailyMed 当前 SPL v15 于 2026-01-23 生效，列示 Bausch Health US LLC、2.5/5/10/20 mg 片、四类 30/90 片瓶装和部分 1,000 片瓶装。网页把原始批准历史、当前美国标签与其他市场未核验边界分开，不用美国商品名或包装推断全球供应。", "sourceDocuments": [ { "id": "src_17772ae97ea9f6ad", "label": "FDA Drugs@FDA：VASOTEC（enalapril maleate）NDA 018998 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018998", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利当前美国公开标签（Bausch Health；SPL v15，2026-01-23 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "FDA NDA 018998（VASOTEC / enalapril maleate；美国原品牌监管档案）", "approvalTimeline": [ { "date": "1985-12-24", "title": { "zh": "VASOTEC 片剂美国原始批准", "en": "Original U.S. approval of VASOTEC tablets" }, "detail": { "zh": "FDA 审评资料将 VASOTEC NDA 018998 列为依那普利马来酸盐片的 reference listed drug，并记录片剂于 1985-12-24 最初获批。该历史节点只建立美国产品史，不自动建立其他市场的品牌、批准、供应或可替代性。", "en": "FDA review material identifies VASOTEC NDA 018998 as the reference listed drug for enalapril maleate tablets and records initial tablet approval on 24 Dec 1985. This historical node establishes U.S. product history only and does not automatically establish another market's brand, approval, supply or interchangeability." }, "source": { "id": "src_17772ae97ea9f6ad", "label": "FDA Drugs@FDA：VASOTEC（enalapril maleate）NDA 018998 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018998", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-01-23", "title": { "zh": "当前美国 VASOTEC SPL v15 生效", "en": "Current U.S. VASOTEC SPL v15 effective" }, "detail": { "zh": "DailyMed 当前标签列示 VASOTEC、NDA018998、Bausch Health US LLC、2.5/5/10/20 mg 刻痕片、准确 NDC、片剂外观和瓶装展示面。页面把标签版本与实时库存、购买和个人适用性分开。", "en": "The current DailyMed label lists VASOTEC, NDA018998, Bausch Health US LLC, scored 2.5/5/10/20 mg tablets, exact NDCs, tablet appearance and bottle display panels. The page keeps label version separate from live stock, purchase and individual suitability." }, "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利当前美国公开标签（SPL v15）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 NDA 品牌标签和四种 30 片瓶装展示面已链接", "en": "Current NDA brand label and four 30-tablet bottle panels linked" }, "detail": { "zh": "分别记录 2.5、5、10、20 mg 的 NDC、颜色、形状、VASO 刻印、刻痕与来源；不用于鉴定真伪，也不建立实时库存、购买、个人片数、频率、掰片、停用、联用或换药方案。", "en": "Separately records NDC, colour, shape, VASO imprint, score and source for 2.5, 5, 10 and 20 mg. It does not authenticate a product or establish live stock, purchase, individual tablet count, frequency, splitting, stopping, co-use or switching." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, the EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行监管产品记录", "en": "Current regulatory product record not established" }, "detail": { "zh": "不从美国 VASOTEC 名称、NDA、共同通用名、NDC、毫克数、刻印或包装图推定当地商品名、批准、包装、供应、原研/参比关系或可替代性；每个市场须按当地现行监管资料逐产品核对。", "en": "No local trade name, approval, packaging, supply, originator/reference relationship or interchangeability is inferred from the U.S. VASOTEC name, NDA, shared generic name, NDC, milligram value, imprint or package image; each product requires current local regulatory review." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "VASOTEC、依那普利、卡托普利和赖诺普利是一回事吗？", "en": "Are VASOTEC, enalapril, captopril and lisinopril the same thing?" }, "answer": { "zh": "VASOTEC 是所引美国依那普利产品的商品名，依那普利是通用名；卡托普利和赖诺普利是不同成分。即使都属于 ACE 抑制剂，也不能据此自行叠加、轮换、按毫克换算或替代。请用实际药盒、处方和完整药单由药师或开方团队核对。", "en": "VASOTEC is the trade name of the cited U.S. enalapril product, while enalapril is the generic name; captopril and lisinopril are different ingredients. Even though all are ACE inhibitors, that does not support self-combining, alternating, milligram conversion or substitution. Have a pharmacist or prescriber review the actual packs, prescription and complete medicine list." } }, { "question": { "zh": "VASOTEC 片上有刻痕，能否掰半就等于减半？", "en": "VASOTEC tablets are scored; can splitting simply make half an amount?" }, "answer": { "zh": "网页不能据刻痕给个人结论。所引美国标签描述的是四个准确 VASOTEC 展示面；刻痕不等于人人都应分片，也不证明另一厂家产品有相同用途。请先核对手中准确产品、处方和现行说明书，再由药师或医生确认。", "en": "The site cannot make an individual decision from a score. The cited U.S. label describes four exact VASOTEC presentations; a score does not mean everyone should split a tablet or prove that another manufacturer's product has the same purpose. Check the exact product, prescription and current label in hand, then confirm with a pharmacist or clinician." } }, { "question": { "zh": "药单里已有缬沙坦、氯沙坦、沙库巴曲/缬沙坦、利尿药、布洛芬或补钾，能一起用吗？", "en": "Can VASOTEC be used with valsartan, losartan, sacubitril/valsartan, a diuretic, ibuprofen or potassium?" }, "answer": { "zh": "网页不能判断个人能否同用。这些名称提示需要把全部处方药、非处方止痛药、补充剂、盐替代品、血压、肾功能和电解质一起交给药师或开方团队逐项核对；不要自行叠加、错开、隔日轮换、停用或替换。", "en": "The site cannot decide individual co-use. These names signal that all prescriptions, OTC pain medicines, supplements, salt substitutes, blood pressure, kidney function and electrolytes need item-by-item review by a pharmacist or prescriber; do not self-combine, separate, alternate by day, stop or substitute." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/vasotec/", "en": "https://origindrug.com/en/drugs/vasotec/" }, "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." ] }