{ "id": "capoten", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "CAPOTEN", "generic": "卡托普利", "aliases": [ "CAPOTEN", "captopril", "卡托普利", "开博通", "NDA 018343", "018343" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "开博通", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_27ece1a130f52a0d", "label": "深圳市市场监督管理局：外包装易混淆药物示例中的卡托普利片（开博通）12.5 mg×20 片（DB4403/T 140—2021，历史药盒线索）", "url": "https://amr.sz.gov.cn/attachment/0/745/745335/9772236.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_guidance", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 CAPOTEN（captopril）NDA 018343 历史原品牌记录与 2015 历史标签；美国当前卡托普利通用名标签；中国大陆 2021 年官方标准中的开博通 12.5 mg×20 片历史药盒线索", "dosageFormClass": "CAPOTEN 历史口服刻痕片：12.5、25、50、100 mg；美国当前卡托普利通用名标签同样列出 12.5、25、50、100 mg；中国历史药盒线索为 12.5 mg×20 片", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1981-04-06（FDA NDA 018343 原始批准）", "archiveSponsorText": "E. R. Squibb and Sons / Squibb 研发历史；FDA 当前 NDA 记录与 2015 CAPOTEN 历史标签；当前持有人、供应和各市场状态须另行核验" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "captopril and hydrochlorothiazide", "卡托普利氢氯噻嗪", "复方卡托普利", "CAPOZIDE" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-capoten-captopril-12-5mg-scored-tablet-historical-2015", "marketCode": "US", "labelVersion": { "zh": "FDA CAPOTEN 美国历史标签（2015；非当前供应或包装结论）", "en": "FDA U.S. historical CAPOTEN label (2015; not a current supply or package finding)" }, "dosageForm": { "zh": "CAPOTEN 卡托普利刻痕口服片", "en": "CAPOTEN captopril scored oral tablet" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 018343 historical label text identity; exact NDC/package panel not established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡托普利 12.5 mg；刻痕片（美国 2015 历史标签；未建立准确包装量）", "en": "Captopril 12.5 mg per tablet; scored tablet (2015 U.S. historical label; exact pack count not established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡托普利", "en": "captopril" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、频率或掰片指令", "en": "historical labelled amount per tablet; not an individual's tablet count, frequency or splitting instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": null, "shape": { "zh": "标签称为刻痕片；未保留可准确对应的官方原品牌包装图", "en": "labelled as scored; no exact official original-brand package image retained" }, "imprint": null, "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN 卡托普利 12.5 mg 刻痕口服片（2015 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-capoten-captopril-25mg-scored-tablet-historical-2015", "marketCode": "US", "labelVersion": { "zh": "FDA CAPOTEN 美国历史标签（2015；非当前供应或包装结论）", "en": "FDA U.S. historical CAPOTEN label (2015; not a current supply or package finding)" }, "dosageForm": { "zh": "CAPOTEN 卡托普利刻痕口服片", "en": "CAPOTEN captopril scored oral tablet" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 018343 historical label text identity; exact NDC/package panel not established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡托普利 25 mg；刻痕片（美国 2015 历史标签；未建立准确包装量）", "en": "Captopril 25 mg per tablet; scored tablet (2015 U.S. historical label; exact pack count not established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡托普利", "en": "captopril" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、频率或掰片指令", "en": "historical labelled amount per tablet; not an individual's tablet count, frequency or splitting instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": null, "shape": { "zh": "标签称为刻痕片；未保留可准确对应的官方原品牌包装图", "en": "labelled as scored; no exact official original-brand package image retained" }, "imprint": null, "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN 卡托普利 25 mg 刻痕口服片（2015 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-capoten-captopril-50mg-scored-tablet-historical-2015", "marketCode": "US", "labelVersion": { "zh": "FDA CAPOTEN 美国历史标签（2015；非当前供应或包装结论）", "en": "FDA U.S. historical CAPOTEN label (2015; not a current supply or package finding)" }, "dosageForm": { "zh": "CAPOTEN 卡托普利刻痕口服片", "en": "CAPOTEN captopril scored oral tablet" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 018343 historical label text identity; exact NDC/package panel not established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡托普利 50 mg；刻痕片（美国 2015 历史标签；未建立准确包装量）", "en": "Captopril 50 mg per tablet; scored tablet (2015 U.S. historical label; exact pack count not established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡托普利", "en": "captopril" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、频率或掰片指令", "en": "historical labelled amount per tablet; not an individual's tablet count, frequency or splitting instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": null, "shape": { "zh": "标签称为刻痕片；未保留可准确对应的官方原品牌包装图", "en": "labelled as scored; no exact official original-brand package image retained" }, "imprint": null, "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN 卡托普利 50 mg 刻痕口服片（2015 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-capoten-captopril-100mg-scored-tablet-historical-2015", "marketCode": "US", "labelVersion": { "zh": "FDA CAPOTEN 美国历史标签（2015；非当前供应或包装结论）", "en": "FDA U.S. historical CAPOTEN label (2015; not a current supply or package finding)" }, "dosageForm": { "zh": "CAPOTEN 卡托普利刻痕口服片", "en": "CAPOTEN captopril scored oral tablet" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 018343 historical label text identity; exact NDC/package panel not established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡托普利 100 mg；刻痕片（美国 2015 历史标签；未建立准确包装量）", "en": "Captopril 100 mg per tablet; scored tablet (2015 U.S. historical label; exact pack count not established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡托普利", "en": "captopril" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、频率或掰片指令", "en": "historical labelled amount per tablet; not an individual's tablet count, frequency or splitting instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": null, "shape": { "zh": "标签称为刻痕片；未保留可准确对应的官方原品牌包装图", "en": "labelled as scored; no exact official original-brand package image retained" }, "imprint": null, "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN 卡托普利 100 mg 刻痕口服片（2015 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-kai-bo-tong-captopril-12-5mg-20tablets-historical-pack-cue-2021", "marketCode": "CN", "labelVersion": { "zh": "深圳市市场监督管理局 DB4403/T 140—2021 历史药盒示例；非当前批准或供应结论", "en": "Historical pack example in Shenzhen market-regulator standard DB4403/T 140—2021; not a current approval or supply finding" }, "dosageForm": { "zh": "开博通 卡托普利片（历史药盒线索）", "en": "Kaibotong captopril tablet (historical pack cue)" }, "route": { "zh": "口服（历史药盒文字线索）", "en": "oral (historical pack-text cue)" }, "routeCodes": [ "oral" ], "productCode": "Current approval number not established from the cited official standard", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "开博通 卡托普利片：每片 12.5 mg，20 片包装（2021 官方标准历史示例）", "en": "Kaibotong captopril tablets: 12.5 mg per tablet, 20-tablet pack (historical 2021 official-standard example)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡托普利", "en": "captopril" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "历史药盒所列每片含量；不是个人片数或当前产品结论", "en": "amount per tablet shown on a historical pack; not an individual tablet count or current-product finding" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 20, "unit": { "zh": "片/盒（历史示例）", "en": "tablets per pack (historical example)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_27ece1a130f52a0d", "label": "深圳市市场监督管理局：卡托普利片（开博通）12.5 mg×20 片历史药盒示例（DB4403/T 140—2021）", "url": "https://amr.sz.gov.cn/attachment/0/745/745335/9772236.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_guidance", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验 CAPOTEN 历史标签与中国历史药盒线索，但未保留可对应当前原品牌的官方包装图，故不展示包装图片", "en": "Historical CAPOTEN label and Chinese pack cues were reviewed, but no official image matching a current original-brand pack was retained, so no package visual is shown" }, "summary": { "zh": "FDA 当前申请记录将 CAPOTEN 品牌规格标为停产；2015 历史标签提供四种刻痕片文字身份，深圳市场监管局 2021 年标准提供“开博通”12.5 mg×20 片历史药盒示例。为避免把历史示意图、零售图、当前通用名包装或其他厂家图片误作现行 CAPOTEN 原品牌外观，页面不展示包装图片，只保留来源、文字身份和历史边界。", "en": "The current FDA application record marks CAPOTEN brand strengths discontinued; the 2015 historical label provides text identities for four scored tablets, and a 2021 Shenzhen market-regulator standard provides a historical Kaibotong 12.5 mg × 20-tablet pack example. To avoid presenting a historical illustration, retail image, current generic pack or another manufacturer's image as current CAPOTEN original-brand appearance, the dossier withholds package imagery and retains source, text identity and historical boundaries." }, "source": { "id": "src_65a94ca75de5d133", "label": "FDA Drugs@FDA：CAPOTEN（captopril）NDA 018343 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018343", "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" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CAPOTEN／开博通／卡托普利说明书放大阅读：先分清历史品牌、通用名和每片毫克数", "en": "CAPOTEN/captopril label reading: separate the historical brand, generic name and milligrams per tablet" }, "summary": { "zh": "本模块把 FDA 的 CAPOTEN 历史原品牌标签、当前卡托普利通用名标签和中国“开博通”历史药盒线索分开呈现。12.5、25、50、100 mg 都是每片标示强度，不是网页给出的个人片数；品牌停产也不等于所有卡托普利产品停产。", "en": "This module separates the FDA historical original-brand CAPOTEN label, a current generic captopril label and the historical Chinese Kaibotong pack cue. 12.5, 25, 50 and 100 mg are strengths per tablet, not personal tablet counts generated by the site; brand discontinuation does not mean every captopril product is discontinued." }, "checks": [ { "zh": "先读完整药盒：CAPOTEN／开博通是历史品牌线索，卡托普利是通用名；同时核对市场、每片强度、是否复方、现行说明书和处方。不要把复方卡托普利或另一种 ACE 抑制剂当作同一盒药。", "en": "Read the whole pack first: CAPOTEN/Kaibotong are historical brand cues and captopril is the generic name. Also check market, strength per tablet, whether it is a combination, the current label and prescription. Do not treat a captopril combination or another ACE inhibitor as the same product." }, { "zh": "标签中的 12.5、25、50、100 mg 表示每片卡托普利含量；它们不能脱离处方、肾功能、血压、电解质、其他药物和用药时间自行换算成片数。", "en": "The 12.5, 25, 50 and 100 mg figures state captopril per tablet; they cannot be converted into a tablet count without the prescription, kidney function, blood pressure, electrolytes, other medicines and timing." }, { "zh": "历史标签写有刻痕，不代表每一种现售卡托普利片都可自行掰开，也不代表半片就适合个人。必须核对手中准确厂家和说明书，并由药师或医生确认。", "en": "A score in the historical label does not mean every currently marketed captopril tablet may be self-split, or that half a tablet suits an individual. Check the exact manufacturer and label in hand and confirm with a pharmacist or clinician." }, { "zh": "把止痛药（尤其 NSAIDs）、利尿药、补钾或含钾盐替代品、其他降压药和全部非处方药放进同一张药单。老人、脱水或肾功能受损者同时使用 NSAID 与 ACE 抑制剂时，FDA 历史标签提示肾功能恶化风险；网页不能替代逐项相互作用复核。", "en": "Put pain medicines (especially NSAIDs), diuretics, potassium supplements or potassium-containing salt substitutes, other blood-pressure medicines and all OTC products on one list. The FDA historical label warns that older, volume-depleted or renally impaired people using an NSAID with an ACE inhibitor may have worsened kidney function; the site cannot replace item-by-item interaction review." }, { "zh": "面部、嘴唇、舌头或喉部肿胀、呼吸或吞咽困难可能是严重血管性水肿，应立即使用当地急救服务；不要等待网页判断，也不要自行补服或换药。", "en": "Swelling of the face, lips, tongue or throat, or breathing/swallowing difficulty may be serious angioedema. Use local emergency services immediately; do not wait for a webpage decision or self-redose/switch." } ], "source": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN（captopril）2015 美国历史处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "卡托普利怎样起作用：抑制 ACE，减少血管紧张素 II 的形成", "en": "How captopril works: ACE inhibition reduces formation of angiotensin II" }, "summary": { "zh": "FDA 标签将卡托普利描述为血管紧张素转换酶（ACE）抑制剂。ACE 参与把血管紧张素 I 转换为血管紧张素 II；后者会收缩血管并促进醛固酮分泌。抑制这条路径可解释血压、血管阻力和钾相关监测为何重要，但不能预测个人反应或决定用量。", "en": "The FDA label describes captopril as an angiotensin-converting-enzyme (ACE) inhibitor. ACE helps convert angiotensin I to angiotensin II, which constricts blood vessels and stimulates aldosterone secretion. Inhibiting this pathway helps explain why blood pressure, vascular resistance and potassium-related monitoring matter, but does not predict individual response or determine an amount." }, "checks": [ { "zh": "“同为降压药”不表示卡托普利能与赖诺普利、缬沙坦、氯沙坦、沙库巴曲/缬沙坦或含利尿剂复方自行叠加、隔日轮换或按毫克换算。", "en": "Being blood-pressure medicines does not make captopril self-combinable, alternate-day interchangeable or milligram-convertible with lisinopril, valsartan, losartan, sacubitril/valsartan or a diuretic combination." }, { "zh": "ACE、肾素、醛固酮等机制词不能替代血压、肾功能、电解质和完整药单的专业判断，也不能成为自行停药或加量的理由。", "en": "Mechanism terms such as ACE, renin and aldosterone do not replace professional review of blood pressure, kidney function, electrolytes and the complete medicine list, and are not a reason for self-stopping or increasing." }, { "zh": "持续干咳、头晕、乏力、排尿变化或其他新症状需要结合实际产品和个体情况评估；若出现面舌喉肿胀、呼吸困难、晕厥或其他严重急性问题，应立即使用当地急救支持。", "en": "Persistent cough, dizziness, weakness, urine change or another new symptom needs review in the context of the exact product and individual. Face/tongue/throat swelling, breathing trouble, fainting or another severe acute problem requires immediate local emergency support." } ], "source": { "id": "src_664e7f95450c5009", "label": "DailyMed（NLM）：卡托普利当前美国通用名公开标签（2024-12-27 更新；临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=607687f4-63cf-411c-a20b-21d238a6b7a7", "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": "CAPOTEN", "generic": "卡托普利", "dosageFormClass": "CAPOTEN 历史口服刻痕片：12.5、25、50、100 mg；美国当前卡托普利通用名标签同样列出 12.5、25、50、100 mg；中国历史药盒线索为 12.5 mg×20 片" }, "labelSource": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN（captopril）2015 美国历史处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN（captopril）2015 美国历史处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "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." } }, { "source": { "id": "src_65a94ca75de5d133", "label": "FDA Drugs@FDA：CAPOTEN（captopril）NDA 018343 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018343", "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." } }, { "source": { "id": "src_664e7f95450c5009", "label": "DailyMed（NLM）：卡托普利当前美国通用名公开标签（Hikma；2024-12-27 更新；ANDA）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=607687f4-63cf-411c-a20b-21d238a6b7a7", "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." } } ], "recordRoute": { "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." } }, "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": "CAPOTEN 是卡托普利的美国历史原品牌档案。FDA NDA 018343 记录可追溯到 1981 年原始批准，2015 年历史标签列出 12.5、25、50、100 mg 刻痕口服片；当前 FDA 申请记录显示品牌规格已停产。页面另链接当前卡托普利通用名标签和中国“开博通”历史药盒线索，帮助老人先分清品牌、通用名、每片毫克数、复方药与市场版本，不生成个人片数、频次或换药方案。", "history": "卡托普利由 Squibb 研究人员开发，是早期口服血管紧张素转换酶（ACE）抑制剂。FDA NDA 018343 于 1981-04-06 获原始批准；2015 年 CAPOTEN 历史标签仍列出四种刻痕片。FDA 当前申请记录将这些品牌规格标为 discontinued，并保留“并非因安全性或有效性原因撤市”的说明。中国深圳市场监管局 2021 年官方标准以 12.5 mg×20 片的“开博通”作为历史药盒易混淆示例；该图文只用于名称和包装历史核对，不代表当前批准、供应或真伪认证。", "sourceDocuments": [ { "id": "src_65a94ca75de5d133", "label": "FDA Drugs@FDA：CAPOTEN（captopril）NDA 018343 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018343", "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_3178bcb743e4d743", "label": "FDA：CAPOTEN（captopril）2015 美国历史处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_664e7f95450c5009", "label": "DailyMed（NLM）：卡托普利当前美国通用名公开标签（Hikma；2024-12-27 更新；ANDA）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=607687f4-63cf-411c-a20b-21d238a6b7a7", "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" }, { "id": "src_27ece1a130f52a0d", "label": "深圳市市场监督管理局：卡托普利片（开博通）12.5 mg×20 片历史药盒示例（DB4403/T 140—2021）", "url": "https://amr.sz.gov.cn/attachment/0/745/745335/9772236.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_guidance", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "FDA NDA 018343（CAPOTEN / captopril；美国原品牌历史档案）", "approvalTimeline": [ { "date": "1981-04-06", "title": { "zh": "FDA 批准 CAPOTEN NDA 018343 原始申请", "en": "FDA approved the original CAPOTEN NDA 018343" }, "detail": { "zh": "FDA Drugs@FDA 当前申请数据将 CAPOTEN、captopril、NDA 018343 与 1981-04-06 的 ORIG 1 批准节点连接。该节点建立美国原品牌历史，不自动建立中国大陆或其他市场的批准、品牌、包装、供应或可替代性。", "en": "Current FDA Drugs@FDA application data link CAPOTEN, captopril, NDA 018343 and the ORIG 1 approval node dated 6 Apr 1981. This establishes U.S. original-brand history; it does not automatically establish approval, branding, packaging, supply or interchangeability in Mainland China or another market." }, "source": { "id": "src_65a94ca75de5d133", "label": "FDA Drugs@FDA：CAPOTEN（captopril）NDA 018343 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018343", "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": "2015-05", "title": { "zh": "CAPOTEN 历史标签列出四种刻痕口服片", "en": "Historical CAPOTEN label lists four scored oral-tablet strengths" }, "detail": { "zh": "FDA 2015 历史标签列出 12.5、25、50、100 mg 刻痕口服片，并明确提醒该文件可能不是最新获批标签。本页据此建立有日期的说明书阅读，而不是当前供应或包装结论。", "en": "The FDA 2015 historical label lists 12.5, 25, 50 and 100 mg scored oral tablets and explicitly warns that the document may not be the latest approved label. The dossier uses it as a dated label-reading record, not a current supply or package finding." }, "source": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN（captopril）2015 美国历史处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2024-12-27", "title": { "zh": "当前卡托普利通用名标签更新", "en": "Current generic captopril label updated" }, "detail": { "zh": "DailyMed 当前 Hikma 卡托普利标签于 2024-12-27 更新，营销状态为 ANDA 通用名产品。它用于读取现行成分、强度、警示与相互作用，不把通用名包装误作 CAPOTEN 原品牌包装。", "en": "The current Hikma captopril label on DailyMed was updated 27 Dec 2024 and is marketed under an ANDA. It supports current ingredient, strength, warning and interaction reading without treating a generic pack as CAPOTEN original-brand packaging." }, "source": { "id": "src_664e7f95450c5009", "label": "DailyMed（NLM）：卡托普利当前美国通用名公开标签（Hikma；2024-12-27 更新；ANDA）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=607687f4-63cf-411c-a20b-21d238a6b7a7", "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": "原品牌历史已核验；CAPOTEN 品牌规格在当前 FDA 记录中标为停产", "en": "Original-brand history verified; CAPOTEN strengths are marked discontinued in the current FDA record" }, "detail": { "zh": "FDA 当前申请记录同时保留“并非因安全性或有效性原因撤市”的说明。本页链接 NDA 历史和 2015 历史标签，并另列当前通用名标签；不把历史品牌写成今天仍有库存、可购买或适合个人使用。", "en": "The current FDA application record also retains the statement that discontinuation was not for safety or effectiveness reasons. This dossier links the NDA history and 2015 historical label and separately lists a current generic label; it does not present the historical brand as currently stocked, purchasable or individually suitable." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "仅建立“开博通”12.5 mg×20 片历史药盒线索", "en": "Historical Kaibotong 12.5 mg × 20-tablet pack cue only" }, "detail": { "zh": "深圳市场监管局 2021 年官方标准将其列为外包装易混淆药物示例。该资料支持名称、每片强度、包装量和历史生产企业文字核对，不建立当前批准文号、持有人、供应、原研/仿制关系、真伪或可替代性。", "en": "A 2021 Shenzhen market-regulator standard lists it as a confusing-package example. The material supports checking the name, strength per tablet, pack count and historical manufacturer wording; it does not establish a current approval number, holder, supply, originator/generic relationship, authenticity or interchangeability." } }, { "market": { "zh": "欧盟、日本及其他市场", "en": "European Union, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国 CAPOTEN 历史、卡托普利通用名、共同 ACE 抑制机制或中国历史药盒推定当地品牌、批准、包装、供应、可售资格或可替代性。", "en": "No local brand, approval, package, supply, sale eligibility or interchangeability is inferred from U.S. CAPOTEN history, the captopril generic name, shared ACE-inhibitor mechanism or the historical Chinese pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "CAPOTEN 已停产，是否表示卡托普利不能用了？", "en": "Does CAPOTEN discontinuation mean captopril can no longer be used?" }, "answer": { "zh": "不能这样推断。FDA 当前记录描述的是 CAPOTEN 这一美国品牌规格的营销状态，并注明并非因安全性或有效性原因撤市；DailyMed 仍有当前卡托普利通用名标签。是否存在、获批、供应或适合个人，必须按目标市场和准确产品另行核对。", "en": "No. The current FDA record describes the marketing status of U.S. CAPOTEN brand strengths and says discontinuation was not for safety or effectiveness reasons; DailyMed still provides a current generic captopril label. Existence, approval, supply and individual suitability require separate checking for the target market and exact product." } }, { "question": { "zh": "片上有刻痕，是否可以掰半就等于减半？", "en": "If the tablet is scored, can it simply be split to make half an amount?" }, "answer": { "zh": "网页不能据此给个人结论。历史 CAPOTEN 标签的刻痕只描述该历史产品；手中产品的厂家、剂型、强度、刻痕用途、处方和个人情况都要核对。不要把历史品牌标签或网络图片用于当前另一厂家产品的掰片决定。", "en": "The site cannot make that individual decision. The score in the historical CAPOTEN label describes that historical product; the manufacturer, dosage form, strength, purpose of the score, prescription and individual context for the product in hand all need checking. Do not use a historical brand label or web image to decide splitting for another current manufacturer's product." } }, { "question": { "zh": "药单里还有布洛芬、利尿药、缬沙坦或补钾，可以一起用吗？", "en": "Can captopril be used with ibuprofen, a diuretic, valsartan or potassium on the medicine list?" }, "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、含钾盐替代品、肾功能、电解质和血压一起交给药师或开方团队核对；不要自行叠加、停用、错开或替换。", "en": "The site cannot decide individual co-use. These names signal that all prescriptions, OTC pain medicines, supplements, potassium-containing salt substitutes, kidney function, electrolytes and blood pressure need review together by a pharmacist or prescriber; do not self-combine, stop, separate 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/capoten/", "en": "https://origindrug.com/en/drugs/capoten/" }, "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." ] }