{ "id": "zestoretic", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "ZESTORETIC", "generic": "赖诺普利/氢氯噻嗪片", "aliases": [ "Zestoretic", "lisinopril hydrochlorothiazide", "lisinopril and hydrochlorothiazide", "lisinopril/HCTZ", "赖诺普利氢氯噻嗪", "赖诺普利氢氯噻嗪片", "NDA 019888", "52427-435-90", "52427-436-90", "52427-437-90", "DIN 02045729", "DIN 02045737", "DIN 02103729" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 ZESTORETIC 标签列示赖诺普利/氢氯噻嗪无包衣口服片、三个规格与三个 90 片瓶装面板；FDA Orange Book 当前数据将 NDA 019888 三个规格列为处方 RLD。加拿大：Health Canada DPD 当前索引列出三个在售 DIN，现行产品说明书列示 10/12.5、20/12.5 与 20/25 mg。两个市场记录分别阅读，不把美国 NDC、加拿大 DIN、包装、供应或可替代性互相推定。", "dosageFormClass": "赖诺普利/氢氯噻嗪固定两成分无包衣口服片：10/12.5 mg、20/12.5 mg、20/25 mg；每组两个数字属于同一片内两种成分", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1989", "archiveSponsorText": "Almatica Pharma LLC（美国当前 DailyMed 标签与 FDA Orange Book 数据）；Searchlight Pharma Inc.（加拿大当前 DPD 与产品说明书）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ZESTRIL", "lisinopril tablet", "MICROZIDE", "hydrochlorothiazide capsule", "ENTRESTO", "HYZAAR", "DIOVAN HCT", "AVALIDE", "EXFORGE HCT" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-zestoretic-lisinopril-hctz-tablet-10-12-5mg-90-bottle-ndc-5242743590", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (revised Mar 2025; verified 29 Aug 2026)" }, "dosageForm": { "zh": "ZESTORETIC 赖诺普利/氢氯噻嗪无包衣口服片", "en": "ZESTORETIC lisinopril/hydrochlorothiazide uncoated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 52427-435-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片赖诺普利 10 mg＋氢氯噻嗪 12.5 mg；90 片瓶装", "en": "Lisinopril 10 mg plus hydrochlorothiazide 12.5 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lbl-10mg-12pt5mg.jpg&setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖诺普利", "en": "lisinopril" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用利尿药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色至粉红色", "en": "peach to pink" }, "shape": { "zh": "圆形、双凸、无包衣片，约 6 mm；无刻痕", "en": "round, biconvex, uncoated tablet, about 6 mm; unscored" }, "imprint": "ZESTORETIC / 141", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 10/12.5 mg、NDC 52427-435-90、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zestoretic-lisinopril-hctz-tablet-20-12-5mg-90-bottle-ndc-5242743690", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (revised Mar 2025; verified 29 Aug 2026)" }, "dosageForm": { "zh": "ZESTORETIC 赖诺普利/氢氯噻嗪无包衣口服片", "en": "ZESTORETIC lisinopril/hydrochlorothiazide uncoated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 52427-436-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片赖诺普利 20 mg＋氢氯噻嗪 12.5 mg；90 片瓶装", "en": "Lisinopril 20 mg plus hydrochlorothiazide 12.5 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lbl-20mg-12pt5mg.jpg&setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖诺普利", "en": "lisinopril" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用利尿药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、双凸、无包衣片，约 8 mm；无刻痕", "en": "round, biconvex, uncoated tablet, about 8 mm; unscored" }, "imprint": "ZESTORETIC / 142", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 20/12.5 mg、NDC 52427-436-90、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zestoretic-lisinopril-hctz-tablet-20-25mg-90-bottle-ndc-5242743790", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (revised Mar 2025; verified 29 Aug 2026)" }, "dosageForm": { "zh": "ZESTORETIC 赖诺普利/氢氯噻嗪无包衣口服片", "en": "ZESTORETIC lisinopril/hydrochlorothiazide uncoated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 52427-437-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片赖诺普利 20 mg＋氢氯噻嗪 25 mg；90 片瓶装", "en": "Lisinopril 20 mg plus hydrochlorothiazide 25 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lbl-20mg-25mg.jpg&setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖诺普利", "en": "lisinopril" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用利尿药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色至粉红色", "en": "peach to pink" }, "shape": { "zh": "圆形、双凸、无包衣片，约 8 mm；无刻痕", "en": "round, biconvex, uncoated tablet, about 8 mm; unscored" }, "imprint": "ZESTORETIC / 145", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 20/25 mg、NDC 52427-437-90、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-zestoretic-lisinopril-hctz-tablet-10-12-5mg-90-bottle-ndc-5242743590", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lbl-10mg-12pt5mg.jpg&setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "alt": { "zh": "DailyMed 当前 ZESTORETIC 10/12.5 mg、NDC 52427-435-90、90 片瓶装标签面板", "en": "Current DailyMed ZESTORETIC 10/12.5 mg, NDC 52427-435-90, 90-tablet bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（2025-03 修订）", "presentation": "ZESTORETIC 赖诺普利 10 mg/氢氯噻嗪 12.5 mg 每片，NDC 52427-435-90，90 片瓶装。", "notice": "此图只对应当前 DailyMed 标签中的 ZESTORETIC 10/12.5 mg、NDC 52427-435-90、90 片瓶装面板；不能代表另两个规格、加拿大 DIN/包装、其他市场、仿制药或同类复方产品，也不用于鉴定真伪或决定个人片数。", "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 10/12.5 mg、NDC 52427-435-90、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZESTORETIC 说明书放大阅读：一片已有两种成分，先排查赖诺普利与利尿药重复", "en": "ZESTORETIC label reading: one tablet already has two ingredients; check duplicate lisinopril and diuretics first" }, "summary": { "zh": "ZESTORETIC 每片固定含赖诺普利和氢氯噻嗪。例如 20/12.5 mg 表示同一片内分别含 20 mg 与 12.5 mg；不能把它理解成半片、两片或可与其他产品直接相加换算。", "en": "Each ZESTORETIC tablet contains fixed amounts of lisinopril and hydrochlorothiazide. For example, 20/12.5 mg means 20 mg and 12.5 mg of the two ingredients in one tablet; it is not a half-tablet cue, a two-tablet cue or a sum that can be directly converted across products." }, "checks": [ { "zh": "逐盒核对有效成分。ZESTRIL 是单方赖诺普利，MICROZIDE 是单方氢氯噻嗪；HYZAAR、DIOVAN HCT、AVALIDE 和 EXFORGE HCT 也含氢氯噻嗪。若同时出现在药单，不要自行删掉或加上任何一盒，应让药师或开方团队依据完整处方判断。", "en": "Check the active ingredients on every pack. ZESTRIL is lisinopril alone and MICROZIDE is hydrochlorothiazide alone; HYZAAR, DIOVAN HCT, AVALIDE and EXFORGE HCT also contain hydrochlorothiazide. If they appear together, do not remove or add a pack yourself; a pharmacist or prescriber must review the complete prescriptions." }, { "zh": "ENTRESTO 含沙库巴曲/缬沙坦。当前 ZESTORETIC 标签把含奈普利酶抑制剂的产品列为特殊禁忌边界，并明确 ACE 抑制剂切换前后 36 小时限制；网页不据此给个人安排停药或换药，应立即联系开方团队或药师核对。", "en": "ENTRESTO contains sacubitril/valsartan. The current ZESTORETIC label identifies products containing a neprilysin inhibitor as a special contraindication boundary and states a 36-hour restriction around switching an ACE inhibitor. The site does not use that statement to arrange an individual's stopping or switching; contact the prescriber or pharmacist promptly for review." }, { "zh": "面、唇、舌或咽喉肿胀，吞咽或呼吸困难，可能是血管性水肿；应立即使用当地急救服务。不要等待网页判断。", "en": "Swelling of the face, lips, tongue or throat, or difficulty swallowing or breathing, may be angioedema and requires local emergency services immediately. Do not wait for a website assessment." }, { "zh": "头晕、晕厥、明显乏力、口渴、尿量显著减少、持续呕吐或腹泻、肌肉无力或抽筋、心跳异常，可能与血压、水分、肾功能或电解质变化有关。严重、突然或伴意识异常时应使用当地急救服务。", "en": "Dizziness, fainting, marked weakness, thirst, clearly reduced urine, persistent vomiting or diarrhoea, muscle weakness or cramps, or an abnormal heartbeat may accompany changes in blood pressure, fluid balance, kidney function or electrolytes. Use local emergency services for severe or sudden symptoms or altered consciousness." }, { "zh": "不要自行使用含钾补充剂或含钾代盐。锂盐、布洛芬或萘普生等 NSAID、其他影响肾素-血管紧张素系统的药，以及其他利尿或降压药，都需要结合完整药单核对；老人、水分不足或肾功能异常者尤其需要复核。", "en": "Do not use potassium supplements or potassium-containing salt substitutes without professional review. Lithium, NSAIDs such as ibuprofen or naproxen, other medicines affecting the renin-angiotensin system and other diuretic or blood-pressure medicines require review against the full medicine list, especially in older adults, volume depletion or kidney impairment." }, { "zh": "突然眼痛、视力快速下降或明显视物模糊需要及时就医。标签还提醒使用氢氯噻嗪者做好防晒并按临床建议进行皮肤检查；这不是自行停药理由。", "en": "Sudden eye pain, rapidly reduced vision or marked blurred vision requires prompt medical assessment. The label also advises sun protection and skin screening as clinically directed for hydrochlorothiazide users; this is not a reason to stop treatment independently." }, { "zh": "标签有胎儿毒性黑框警示。已经怀孕、可能怀孕或计划怀孕者应立即联系开方团队核对，不要等待网页判断，也不要用网页自行安排停换药。", "en": "The label carries a boxed warning for fetal toxicity. Anyone who is pregnant, may be pregnant or plans pregnancy should contact the prescribing team promptly; do not wait for a website decision or use the site to arrange stopping or switching." } ], "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 赖诺普利/氢氯噻嗪当前美国公开标签（Almatica；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样协同：一项减少血管紧张素 II 形成，一项帮助排出钠和水", "en": "How the two ingredients work together: one reduces angiotensin II formation and one increases sodium and water excretion" }, "summary": { "zh": "当前标签说明：赖诺普利抑制血管紧张素转换酶，使血管紧张素 II 形成减少并降低醛固酮分泌；氢氯噻嗪减少一部分钠和氯的重吸收，使更多钠和水随尿排出。两条路径放在同一片中，不表示网页能按血压数字拆分或重组个人方案。", "en": "The current label explains that lisinopril inhibits angiotensin-converting enzyme, reducing angiotensin II formation and aldosterone secretion, while hydrochlorothiazide reduces sodium and chloride reabsorption so more sodium and water leave in urine. Combining both paths in one tablet does not let the site split or rebuild an individual's regimen from a blood-pressure number." }, "checks": [ { "zh": "赖诺普利成分可能影响钾和肾功能，氢氯噻嗪成分可能造成低钾、低钠、低镁，也会影响尿酸、血糖、血脂和钙；不能只看“降压”两个字忽略化验、症状和完整药单。", "en": "Lisinopril can affect potassium and kidney function; hydrochlorothiazide can cause low potassium, sodium or magnesium and affect urate, glucose, lipids and calcium. The words 'blood pressure' must not replace symptoms, laboratory review and the complete medicine list." }, { "zh": "三组双数字是三种完整产品身份。不同 mg 组合、颜色、印字、NDC 与加拿大 DIN 不能由网页转换成个人加量、减量、掰片、补服或交替使用。", "en": "The three paired strengths are three complete product identities. Different milligram pairs, colours, imprints, NDCs and Canadian DINs cannot be converted by the site into an individual increase, decrease, split, make-up use or alternation plan." }, { "zh": "老人或存在肾功能、肝功能、糖尿病、痛风、水分不足等情况时，更需要专业人员结合实际药盒和监测结果复核；网页不根据年龄或化验自动生成方案。", "en": "Older adults and people with kidney or liver impairment, diabetes, gout or volume depletion particularly need professional review using the actual packs and monitoring results; the site does not generate a regimen from age or laboratory values." } ], "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 赖诺普利/氢氯噻嗪当前美国公开标签（Almatica；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ZESTORETIC", "generic": "赖诺普利/氢氯噻嗪片", "dosageFormClass": "赖诺普利/氢氯噻嗪固定两成分无包衣口服片：10/12.5 mg、20/12.5 mg、20/25 mg；每组两个数字属于同一片内两种成分" }, "labelSource": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 赖诺普利/氢氯噻嗪当前美国公开标签（Almatica；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 赖诺普利/氢氯噻嗪当前美国公开标签（Almatica；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：ZESTORETIC，NDA 019888，三个口服片规格均列为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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": "2026-08-29", "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": "ZESTORETIC 一片同时含赖诺普利和氢氯噻嗪。药盒上的 10/12.5、20/12.5 或 20/25 不是分片算式，而是每片两种成分各有多少毫克。若药单还有单方 ZESTRIL、MICROZIDE，或 HYZAAR、DIOVAN HCT、AVALIDE、EXFORGE HCT 等其他含氢氯噻嗪产品，应先让药师或开方团队核对是否重复；若出现 ENTRESTO，还要按官方说明书核对 ACE 抑制剂的特殊间隔边界。不要自行加药、停药或轮换。", "history": "FDA Orange Book 当前数据记录 ZESTORETIC NDA 019888：20/25 mg 于 1989-07-20 获批，20/12.5 mg 于 1990-09-20 获批，10/12.5 mg 于 1993-11-18 获批；三个规格均列为处方 RLD。当前美国 DailyMed 标签于 2025-03 修订。加拿大产品说明书记录初次授权日为 1992-10-07、修订日为 2023-11-10；DPD 当前索引于 2025-03-22 更新，列出三个在售 DIN。", "sourceDocuments": [ { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 赖诺普利/氢氯噻嗪当前美国公开标签（Almatica；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：ZESTORETIC，NDA 019888，三个口服片规格均列为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 ZESTORETIC／DIN 的官方入口", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_1400461f2de8298b", "label": "Health Canada：ZESTORETIC 加拿大产品说明书（10/12.5、20/12.5、20/25 mg；2023-11-10 修订）", "url": "https://pdf.hres.ca/dpd_pm/00073386.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_monograph", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 019888（ZESTORETIC / lisinopril and hydrochlorothiazide oral tablets）", "approvalTimeline": [ { "date": "1989-07-20", "title": { "zh": "20/25 mg 原始批准", "en": "Original approval of 20/25 mg" }, "detail": { "zh": "Orange Book 当前数据将该规格列为 NDA 019888 产品 002 和处方 RLD。", "en": "Current Orange Book data list this strength as NDA 019888 product 002 and a prescription RLD." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：ZESTORETIC，NDA 019888，三个口服片规格均列为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1990-09-20", "title": { "zh": "20/12.5 mg 获批", "en": "Approval of 20/12.5 mg" }, "detail": { "zh": "Orange Book 当前数据将该规格列为产品 001、处方 RLD。", "en": "Current Orange Book data list this strength as product 001 and a prescription RLD." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：ZESTORETIC，NDA 019888，三个口服片规格均列为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1992-10-07", "title": { "zh": "加拿大初次授权节点", "en": "Canadian initial authorisation milestone" }, "detail": { "zh": "加拿大现行产品说明书记录该初次授权日期；加拿大监管记录与美国 NDA 分开阅读。", "en": "The current Canadian product monograph records this initial authorisation date; the Canadian regulatory record is read separately from the U.S. NDA." }, "source": { "id": "src_1400461f2de8298b", "label": "Health Canada：ZESTORETIC 加拿大产品说明书（10/12.5、20/12.5、20/25 mg；2023-11-10 修订）", "url": "https://pdf.hres.ca/dpd_pm/00073386.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_monograph", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1993-11-18", "title": { "zh": "10/12.5 mg 获批", "en": "Approval of 10/12.5 mg" }, "detail": { "zh": "Orange Book 当前数据将该规格列为产品 003、处方 RLD。", "en": "Current Orange Book data list this strength as product 003 and a prescription RLD." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：ZESTORETIC，NDA 019888，三个口服片规格均列为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2023-11-10", "title": { "zh": "加拿大现行产品说明书修订", "en": "Current Canadian product monograph revised" }, "detail": { "zh": "现行说明书列示三个双成分规格及加拿大产品安全信息；不用于推定美国包装。", "en": "The current monograph lists the three two-ingredient strengths and Canadian product safety information; it does not establish a U.S. pack." }, "source": { "id": "src_1400461f2de8298b", "label": "Health Canada：ZESTORETIC 加拿大产品说明书（10/12.5、20/12.5、20/25 mg；2023-11-10 修订）", "url": "https://pdf.hres.ca/dpd_pm/00073386.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_monograph", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-03-31", "title": { "zh": "当前美国 DailyMed 页面更新", "en": "Current U.S. DailyMed page updated" }, "detail": { "zh": "DailyMed 当前页面保留三个准确包装面板、黑框警示、禁忌、相互作用和其他说明书入口。", "en": "The current DailyMed page retains three exact pack panels, the boxed warning, contraindications, interactions and other label-reading routes." }, "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 赖诺普利/氢氯噻嗪当前美国公开标签（Almatica；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 DailyMed 品牌标签；Orange Book 三规格均列为处方 RLD", "en": "Current DailyMed brand label; all three strengths are listed as prescription RLD products in the Orange Book" }, "detail": { "zh": "本页展示三个 90 片瓶装面板；不由标签推断特定药店库存或购买资格。", "en": "This page displays three 90-tablet bottle panels; the label does not establish stock at a particular pharmacy or purchasing eligibility." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "DPD 三个 DIN 当前列为在售；现行产品说明书已链接", "en": "Three DINs are currently listed as marketed in the DPD; current product monograph linked" }, "detail": { "zh": "DIN 02045729、02045737、02103729 属加拿大市场记录；不与美国 NDC 或包装混写，也不证明特定药房实时库存。", "en": "DIN 02045729, 02045737 and 02103729 are Canadian market records; they are not merged with U.S. NDCs or packs and do not establish live stock at a particular pharmacy." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国或加拿大品牌、共同成分或 mg 数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the U.S. or Canadian brand, shared ingredients or milligram numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "20/12.5 mg 是不是把药片掰一半？", "en": "Does 20/12.5 mg mean splitting the tablet in half?" }, "answer": { "zh": "不是。它表示同一片内有赖诺普利 20 mg 和氢氯噻嗪 12.5 mg。美国标签列示片剂无刻痕；网页不会把双数字转换为掰片或个人片数。", "en": "No. It means one tablet contains lisinopril 20 mg and hydrochlorothiazide 12.5 mg. The U.S. label lists the tablets as unscored, and the site does not convert the paired numbers into splitting or an individual tablet count." } }, { "question": { "zh": "已经吃 ZESTORETIC，还能再吃 ZESTRIL 或 MICROZIDE 吗？", "en": "Can ZESTRIL or MICROZIDE be taken in addition to ZESTORETIC?" }, "answer": { "zh": "网页不能替个人决定。ZESTORETIC 已含赖诺普利和氢氯噻嗪，再出现单方同成分可能是重复，也可能是专业人员有意安排；只有准确处方、实际药盒和完整药单才能判断。不要自行加上或停掉任何一盒。", "en": "The website cannot decide for an individual. ZESTORETIC already contains lisinopril and hydrochlorothiazide, so an additional single-ingredient product may be duplicative or intentionally prescribed; only exact prescriptions, packs and the complete medicine list can establish that. Do not add or stop a pack yourself." } }, { "question": { "zh": "美国 NDC 和加拿大 DIN 能直接对照换药吗？", "en": "Can a U.S. NDC and a Canadian DIN be used to switch products directly?" }, "answer": { "zh": "不能。它们是不同监管市场的产品标识。即使双成分和 mg 数字相近，也必须分别核对当地说明书、剂型、包装、处方和专业人员判断。", "en": "No. They are product identifiers from different regulatory markets. Even when the two ingredients and milligram numbers look similar, the local monograph, dosage form, pack, prescription and professional review must be checked separately." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zestoretic/", "en": "https://origindrug.com/en/drugs/zestoretic/" }, "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." ] }