{ "id": "hyzaar", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "HYZAAR", "generic": "氯沙坦钾/氢氯噻嗪片", "aliases": [ "Hyzaar", "losartan hydrochlorothiazide", "losartan/HCTZ", "氯沙坦氢氯噻嗪", "氯沙坦钾氢氯噻嗪片", "losartan potassium and hydrochlorothiazide", "氯沙坦钾/氢氯噻嗪", "氯沙坦氢氯噻嗪片", "NDA 020387", "78206-139-01", "78206-140-01", "78206-141-01" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 HYZAAR 标签列示氯沙坦钾/氢氯噻嗪薄膜衣口服片、三个规格及 30 片和 90 片瓶装；本档案精确展示三个 30 片瓶装面板。FDA Orange Book 当前数据将 NDA 020387 的三个规格列为处方 RLD。页面不由此推定其他市场的名称、包装、供应、可售资格或可替代性。", "dosageFormClass": "氯沙坦钾/氢氯噻嗪固定两成分薄膜衣口服片：50/12.5 mg、100/12.5 mg、100/25 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": "1995", "archiveSponsorText": "Organon LLC（当前 DailyMed 标签与 FDA Orange Book 数据所列主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "COZAAR", "losartan potassium tablet", "MICROZIDE", "hydrochlorothiazide capsule", "AVALIDE", "EXFORGE HCT" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-hyzaar-losartan-hctz-tablet-50-12-5mg-30-bottle-ndc-7820613901", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（处方信息 2025-06 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (prescribing information revised Jun 2025; verified 29 Aug 2026)" }, "dosageForm": { "zh": "HYZAAR 氯沙坦钾/氢氯噻嗪薄膜衣口服片", "en": "HYZAAR losartan potassium/hydrochlorothiazide film-coated 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 78206-139-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯沙坦钾 50 mg＋氢氯噻嗪 12.5 mg；30 片瓶装", "en": "Losartan potassium 50 mg plus hydrochlorothiazide 12.5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=hyzaar-03.jpg&setid=4116ccde-2e23-45f4-b12f-6337df877744&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯沙坦钾", "en": "losartan potassium" }, "value": 50, "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": 30, "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": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形薄膜衣片，约 11 mm；无刻痕", "en": "oval film-coated tablet, about 11 mm; unscored" }, "imprint": "717", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 50/12.5 mg、NDC 78206-139-01、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "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-hyzaar-losartan-hctz-tablet-100-12-5mg-30-bottle-ndc-7820614001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（处方信息 2025-06 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (prescribing information revised Jun 2025; verified 29 Aug 2026)" }, "dosageForm": { "zh": "HYZAAR 氯沙坦钾/氢氯噻嗪薄膜衣口服片", "en": "HYZAAR losartan potassium/hydrochlorothiazide film-coated 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 78206-140-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯沙坦钾 100 mg＋氢氯噻嗪 12.5 mg；30 片瓶装", "en": "Losartan potassium 100 mg plus hydrochlorothiazide 12.5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=hyzaar-04.jpg&setid=4116ccde-2e23-45f4-b12f-6337df877744&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯沙坦钾", "en": "losartan potassium" }, "value": 100, "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": 30, "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": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片，约 13 mm；无刻痕", "en": "oval film-coated tablet, about 13 mm; unscored" }, "imprint": "745", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 100/12.5 mg、NDC 78206-140-01、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "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-hyzaar-losartan-hctz-tablet-100-25mg-30-bottle-ndc-7820614101", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（处方信息 2025-06 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (prescribing information revised Jun 2025; verified 29 Aug 2026)" }, "dosageForm": { "zh": "HYZAAR 氯沙坦钾/氢氯噻嗪薄膜衣口服片", "en": "HYZAAR losartan potassium/hydrochlorothiazide film-coated 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 78206-141-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯沙坦钾 100 mg＋氢氯噻嗪 25 mg；30 片瓶装", "en": "Losartan potassium 100 mg plus hydrochlorothiazide 25 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=hyzaar-05.jpg&setid=4116ccde-2e23-45f4-b12f-6337df877744&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯沙坦钾", "en": "losartan potassium" }, "value": 100, "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": 30, "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": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light yellow" }, "shape": { "zh": "椭圆形薄膜衣片，约 16 mm；无刻痕", "en": "oval film-coated tablet, about 16 mm; unscored" }, "imprint": "747", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 100/25 mg、NDC 78206-141-01、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "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-hyzaar-losartan-hctz-tablet-50-12-5mg-30-bottle-ndc-7820613901", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=hyzaar-03.jpg&setid=4116ccde-2e23-45f4-b12f-6337df877744&type=img", "alt": { "zh": "DailyMed 当前 HYZAAR 50/12.5 mg、NDC 78206-139-01、30 片瓶装标签面板", "en": "Current DailyMed HYZAAR 50/12.5 mg, NDC 78206-139-01, 30-tablet bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（处方信息 2025-06 修订）", "presentation": "HYZAAR 氯沙坦钾 50 mg/氢氯噻嗪 12.5 mg 每片，NDC 78206-139-01，30 片瓶装。", "notice": "此图只对应当前 DailyMed 标签中的 HYZAAR 50/12.5 mg、NDC 78206-139-01、30 片瓶装面板；不能代表 100/12.5 mg、100/25 mg、90 片瓶装、其他市场、仿制药或复方同类产品，也不用于鉴定真伪或决定个人片数。", "source": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 50/12.5 mg、NDC 78206-139-01、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "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": "HYZAAR 说明书放大阅读：斜线两边是两种成分，不是分片或加量公式", "en": "HYZAAR label reading: the two numbers are two ingredients, not a splitting or dose formula" }, "summary": { "zh": "HYZAAR 每片固定含氯沙坦钾和氢氯噻嗪。比如 50/12.5 mg 表示同一片内分别含 50 mg 与 12.5 mg；不能把它理解成半片、两片、总量 62.5 mg 后与另一种药直接换算。", "en": "Each HYZAAR tablet contains fixed amounts of losartan potassium and hydrochlorothiazide. For example, 50/12.5 mg means 50 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 62.5 mg total that can be directly converted to another product." }, "checks": [ { "zh": "逐盒核对有效成分。COZAAR 是单方氯沙坦，MICROZIDE 是单方氢氯噻嗪；AVALIDE 与 EXFORGE HCT 也含氢氯噻嗪。若它们与 HYZAAR 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是否有意联用或重复。", "en": "Check the active ingredients on every pack. COZAAR is losartan alone, MICROZIDE is hydrochlorothiazide alone, and AVALIDE and EXFORGE HCT also contain hydrochlorothiazide. If any appear together with HYZAAR, do not remove or add a pack yourself; a pharmacist or prescriber must use the complete prescriptions to determine whether use is intentional or duplicative." }, { "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、非甾体抗炎止痛药、其他影响肾素-血管紧张素系统的药物，以及其他利尿或降压药，都需要结合完整药单核对。", "en": "Do not use potassium supplements or potassium-containing salt substitutes without professional review. Lithium, NSAID pain medicines, other medicines affecting the renin-angiotensin system and other diuretic or blood-pressure medicines all require review against the complete medicine list." }, { "zh": "突然眼痛、视力快速下降或明显视物模糊需要及时就医；面唇舌喉肿胀、呼吸困难或晕厥应使用当地急救服务。", "en": "Sudden eye pain, rapidly reduced vision or marked blurred vision requires prompt medical assessment. Swelling of the face, lips, tongue or throat, breathing difficulty or fainting requires local emergency services." }, { "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." }, { "zh": "标签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；这不是说一定会发生皮肤癌，也不是自行停药理由。", "en": "The label advises sun protection and skin screening as clinically directed for hydrochlorothiazide users. This does not mean skin cancer will occur and is not a reason to stop treatment independently." } ], "source": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 氯沙坦钾/氢氯噻嗪当前美国公开标签（Organon；处方信息 2025-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "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：一项阻断血管紧张素 II 信号，一项帮助排出钠和水", "en": "How the two ingredients work together: one blocks angiotensin II signalling and one increases sodium and water excretion" }, "summary": { "zh": "当前标签说明：氯沙坦及其活性代谢物阻断血管紧张素 II 与 AT1 受体结合，从而减少血管收缩和醛固酮相关作用；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，不代表网页能按血压数字拆分或重组个人方案。", "en": "The current label explains that losartan and its active metabolite block angiotensin II binding at the AT1 receptor, reducing vasoconstrictor and aldosterone-related effects, 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": "氯沙坦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": "The losartan component can affect potassium and kidney function; the hydrochlorothiazide component can cause low potassium, sodium or magnesium and affect urate, glucose, lipids and calcium. The word 'blood pressure' alone must not replace symptoms, laboratory review and the complete medicine list." }, { "zh": "50/12.5、100/12.5 和 100/25 是三种完整产品身份。不同 mg 组合、颜色、印字和 NDC 不能由网页转换成个人加量、减量、掰片、补服或交替使用。", "en": "50/12.5, 100/12.5 and 100/25 are three complete product identities. Different milligram pairs, colours, imprints and NDCs 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_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 氯沙坦钾/氢氯噻嗪当前美国公开标签（Organon；处方信息 2025-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "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": "HYZAAR", "generic": "氯沙坦钾/氢氯噻嗪片", "dosageFormClass": "氯沙坦钾/氢氯噻嗪固定两成分薄膜衣口服片：50/12.5 mg、100/12.5 mg、100/25 mg；每组两个数字属于同一片内两种成分" }, "labelSource": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 氯沙坦钾/氢氯噻嗪当前美国公开标签（Organon；处方信息 2025-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "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_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 氯沙坦钾/氢氯噻嗪当前美国公开标签（Organon；处方信息 2025-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "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：HYZAAR，NDA 020387，三个口服片规格均为处方 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": "HYZAAR 一片同时含氯沙坦钾和氢氯噻嗪。药盒上的 50/12.5、100/12.5 或 100/25 不是“吃半片”的算式，而是每片两种成分各有多少毫克。若药单还有 COZAAR、MICROZIDE，或 AVALIDE、EXFORGE HCT 等其他含氢氯噻嗪产品，要先让药师或开方团队核对是否重复；不要自行加药、停药或轮换。", "history": "FDA Orange Book 当前数据记录 HYZAAR NDA 020387：50/12.5 mg 于 1995-04-28 获批，100/25 mg 于 1998-11-10 获批，100/12.5 mg 于 2005-10-20 获批；三个规格均列为处方 RLD。当前 DailyMed 标签的三个 30 片瓶装面板分别对应 NDC 78206-139-01、78206-140-01 和 78206-141-01。", "sourceDocuments": [ { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 氯沙坦钾/氢氯噻嗪当前美国公开标签（Organon；处方信息 2025-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "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：HYZAAR，NDA 020387，三个口服片规格均为处方 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" } ], "applicationNumber": "FDA NDA 020387（HYZAAR / losartan potassium and hydrochlorothiazide oral tablets）", "approvalTimeline": [ { "date": "1995-04-28", "title": { "zh": "50/12.5 mg 原始批准", "en": "Original approval of 50/12.5 mg" }, "detail": { "zh": "Orange Book 当前数据将该规格列为 NDA 020387 产品 001、处方 RLD。", "en": "Current Orange Book data list this strength as NDA 020387 product 001 and a prescription RLD." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：HYZAAR，NDA 020387，三个口服片规格均为处方 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": "1998-11-10", "title": { "zh": "100/25 mg 获批", "en": "Approval of 100/25 mg" }, "detail": { "zh": "Orange Book 当前数据将该规格列为产品 002、处方 RLD。", "en": "Current Orange Book data list this strength as product 002 and a prescription RLD." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：HYZAAR，NDA 020387，三个口服片规格均为处方 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": "2005-10-20", "title": { "zh": "100/12.5 mg 获批", "en": "Approval of 100/12.5 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：HYZAAR，NDA 020387，三个口服片规格均为处方 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": "2025-06", "title": { "zh": "当前公开处方信息修订", "en": "Current public prescribing-information revision" }, "detail": { "zh": "DailyMed 当前页面保留三个规格、外观、包装、黑框警示及药物相互作用等说明书入口。", "en": "The current DailyMed page retains the three strengths, appearances, packs, boxed warning, interactions and other label-reading routes." }, "source": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 氯沙坦钾/氢氯噻嗪当前美国公开标签（Organon；处方信息 2025-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "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 三个规格均列为处方 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 30 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 30-tablet bottle panels; the label does not establish stock at a particular pharmacy or purchasing eligibility." } }, { "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. brand, shared ingredients or milligram numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "50/12.5 mg 是不是把药片掰一半？", "en": "Does 50/12.5 mg mean splitting the tablet in half?" }, "answer": { "zh": "不是。它表示同一片内有氯沙坦钾 50 mg 和氢氯噻嗪 12.5 mg。标签列示这些片剂无刻痕；网页也不会把 mg 组合转换为掰片或个人片数。", "en": "No. It means one tablet contains losartan potassium 50 mg and hydrochlorothiazide 12.5 mg. The label lists these tablets as unscored, and the site does not convert the milligram pair into splitting or an individual tablet count." } }, { "question": { "zh": "已经吃 HYZAAR，还能再吃 COZAAR 或 MICROZIDE 吗？", "en": "Can COZAAR or MICROZIDE be taken in addition to HYZAAR?" }, "answer": { "zh": "网页不能替个人决定。HYZAAR 已含氯沙坦和氢氯噻嗪，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. HYZAAR already contains losartan and hydrochlorothiazide, so an additional single-ingredient product may be duplicative or may be intentionally prescribed; only the exact prescriptions, packs and complete medicine list can establish that. Do not add or stop a pack yourself." } }, { "question": { "zh": "三种 HYZAAR 颜色不同，能按颜色互相替换吗？", "en": "Can the three HYZAAR products be substituted by colour?" }, "answer": { "zh": "不能。黄色 717、白色 745、浅黄色 747 分别对应不同的两成分强度与 NDC；颜色只作辅助外观线索，不能证明真伪、适用性或可替代性。", "en": "No. Yellow 717, white 745 and light-yellow 747 correspond to different two-ingredient strengths and NDCs. Colour is only an appearance clue and does not establish authenticity, suitability or interchangeability." } } ], "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/hyzaar/", "en": "https://origindrug.com/en/drugs/hyzaar/" }, "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." ] }