{ "id": "microzide", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "MICROZIDE", "generic": "氢氯噻嗪胶囊", "aliases": [ "Microzide", "hydrochlorothiazide", "HCTZ", "氢氯噻嗪", "氢氯噻嗪胶囊", "MICROZIDE 12.5 mg", "NDA 020504", "52544-622-01" ], "marketBrandNames": [ { "name": "MICROZIDE", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "FDA Orange Book 当前数据：NDA 020504，氢氯噻嗪 12.5 mg 口服胶囊，处方药 RLD/RS；当前准确 NDC 与包装未在本次审阅中建立。", "en": "Current FDA Orange Book data: NDA 020504, hydrochlorothiazide 12.5 mg oral capsule, prescription RLD/RS; an exact current NDC and pack were not established in this review." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：MICROZIDE（hydrochlorothiazide）NDA 020504，12.5 mg 口服胶囊；处方药 RLD 与 RS", "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" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：FDA Orange Book 当前数据列示 MICROZIDE、hydrochlorothiazide 12.5 mg、口服胶囊、NDA 020504、处方药 RLD/RS；页面另引用 2020 年 FDA 标签和已结束营销的 2011 年 DailyMed 准确包装，不把旧 NDC 或旧包装写成当前包装", "dosageFormClass": "氢氯噻嗪 12.5 mg 口服胶囊；不是氢氯噻嗪片，也不是已经含氢氯噻嗪的复方片", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1996", "archiveSponsorText": "Teva Branded Pharmaceutical Products R&D LLC（FDA Orange Book 当前数据所列申请人）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "hydrochlorothiazide tablet", "氢氯噻嗪片", "AVALIDE", "irbesartan hydrochlorothiazide", "EXFORGE HCT", "amlodipine valsartan hydrochlorothiazide", "HYZAAR", "losartan hydrochlorothiazide" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-microzide-hydrochlorothiazide-12-5mg-100-capsule-bottle-ndc-5254462201-historical", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史标签（2011-10 修订；该 NDC 营销结束 2020-08-31）", "en": "Historical U.S. DailyMed label (revised Oct 2011; marketing for this NDC ended 31 Aug 2020)" }, "dosageForm": { "zh": "MICROZIDE 氢氯噻嗪硬明胶口服胶囊", "en": "MICROZIDE hydrochlorothiazide hard-gelatin oral capsule" }, "route": { "zh": "口服（历史产品身份字段）", "en": "oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 52544-622-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒氢氯噻嗪 12.5 mg；100 粒瓶装（历史包装）", "en": "Hydrochlorothiazide 12.5 mg per capsule; 100-capsule bottle (historical pack)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=microzide-capsule-2.jpg&archiveid=377471", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒历史标签标示量；不是个人粒数、频次或补服指令", "en": "historical labelled amount per capsule; not an individual's capsule count, frequency or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装（历史）", "en": "bottle (historical)" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_label_marketing_end_2020", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝绿色不透明", "en": "teal opaque" }, "shape": { "zh": "两节式 4 号硬明胶胶囊；无刻痕", "en": "two-piece size 4 hard-gelatin capsule; unscored" }, "imprint": "MICROZIDE / 12.5 mg", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_46382e935f7dacef", "label": "DailyMed（NLM）：MICROZIDE 12.5 mg、NDC 52544-622-01、100 粒瓶装历史标签（2011-10 修订；营销结束 2020-08-31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=afbefaff-97c4-4f84-b989-1595f882a885", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_archive", "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-microzide-hydrochlorothiazide-12-5mg-100-capsule-bottle-ndc-5254462201-historical", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=microzide-capsule-2.jpg&archiveid=377471", "alt": { "zh": "DailyMed 历史 MICROZIDE 12.5 mg、NDC 52544-622-01、100 粒瓶装标签面板", "en": "Historical DailyMed MICROZIDE 12.5 mg, NDC 52544-622-01, 100-capsule bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 美国历史标签（2011-10 修订；营销结束 2020-08-31）", "presentation": "MICROZIDE 氢氯噻嗪胶囊：每粒 12.5 mg，NDC 52544-622-01，100 粒瓶装历史标签面板。", "notice": "此图只对应 DailyMed 2011 年历史标签中的 MICROZIDE、氢氯噻嗪 12.5 mg、NDC 52544-622-01 与 100 粒瓶装；该 NDC 的营销记录已于 2020-08-31 结束。图片不用于鉴定真伪，也不证明当前 NDC、当前包装、库存、其他市场、氢氯噻嗪片、任何复方药、可替代性或个人使用方案。", "source": { "id": "src_46382e935f7dacef", "label": "DailyMed（NLM）：MICROZIDE 12.5 mg、NDC 52544-622-01、100 粒瓶装历史标签（2011-10 修订；营销结束 2020-08-31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=afbefaff-97c4-4f84-b989-1595f882a885", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_archive", "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": "MICROZIDE 说明书放大阅读：先查是否与复方药重复，再看水分与电解质信号", "en": "MICROZIDE label reading: check combination-product duplication first, then fluid and electrolyte signals" }, "summary": { "zh": "MICROZIDE 是每粒 12.5 mg 的氢氯噻嗪胶囊。12.5 mg 是每粒标签量，不是网页建议一次吃几粒；同一成分也可能藏在复方降压药里。", "en": "MICROZIDE is a hydrochlorothiazide capsule labelled 12.5 mg per capsule. The 12.5 mg is a product-identity amount, not this site's recommended capsule count, and the same ingredient may also be present inside a combination blood-pressure medicine." }, "checks": [ { "zh": "逐盒看“有效成分”。AVALIDE 已含厄贝沙坦/氢氯噻嗪，EXFORGE HCT 已含氨氯地平/缬沙坦/氢氯噻嗪；若完整药单还有 MICROZIDE 或另一盒 HCTZ，应交给药师或开方团队核对是否重复，不要自行停掉其中一盒。", "en": "Read the active ingredients on every pack. AVALIDE already contains irbesartan/hydrochlorothiazide, while EXFORGE HCT contains amlodipine/valsartan/hydrochlorothiazide. If MICROZIDE or another HCTZ product is also on the full list, ask a pharmacist or prescriber to check for duplication; do not stop one yourself." }, { "zh": "口干、明显口渴、乏力、嗜睡、烦躁、肌肉疼痛或抽筋、心跳加快、头晕、尿量明显减少、持续恶心或呕吐，可能与水分或电解质变化有关。严重、突然或伴晕厥、意识异常时应立即寻求当地急救。", "en": "Dry mouth, marked thirst, weakness, drowsiness, restlessness, muscle pain or cramps, fast heartbeat, dizziness, clearly reduced urine, persistent nausea or vomiting may accompany fluid or electrolyte changes. Seek local emergency help for severe or sudden symptoms, fainting or altered consciousness." }, { "zh": "老人、肾功能或肝功能异常、痛风或高尿酸、糖尿病，以及同时使用其他降压药、地高辛、激素、锂盐、止痛抗炎药或酒精时，都需要把准确药盒和完整药单一起核对。网页不从年龄、化验或血压数字自动给出加减量。", "en": "Older adults, kidney or liver impairment, gout or high urate, diabetes, and co-use of other blood-pressure medicines, digoxin, corticosteroids, lithium, pain or anti-inflammatory medicines, or alcohol all require review of the exact packs and complete medicine list. The site does not generate an adjustment from age, laboratory or blood-pressure numbers." }, { "zh": "突然眼痛、视力快速下降或明显视物模糊需要及时就医；出现面唇舌喉肿胀、呼吸困难或严重皮肤反应应使用当地急救服务。不要等待网页判断是否与药物有关。", "en": "Sudden eye pain, rapid loss of vision or marked blurred vision needs prompt medical assessment. Swelling of the face, lips, tongue or throat, breathing difficulty or a severe skin reaction requires local emergency services. Do not wait for the website to decide whether the medicine caused it." }, { "zh": "有日期的 FDA 标签提醒长期用药者做好防晒并按临床建议进行皮肤检查。该信息不是说服药者一定会发生皮肤癌，也不是自行停药理由；发现新生、变化、出血或不愈合的皮损应联系专业人员。", "en": "The dated FDA label advises sun protection and regular skin checks as clinically directed during long-term use. This does not mean a user will develop skin cancer and is not a reason to stop treatment independently; seek professional assessment for a new, changing, bleeding or non-healing skin lesion." } ], "source": { "id": "src_112ef053c229398f", "label": "FDA：MICROZIDE（hydrochlorothiazide）12.5 mg 胶囊美国处方信息（2020-08 修订；标签注明可能不是最新版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020504s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "氢氯噻嗪怎样起作用：减少钠和氯的重吸收，让更多水随尿排出", "en": "How hydrochlorothiazide works: reducing sodium and chloride reabsorption so more water leaves in urine" }, "summary": { "zh": "FDA 标签说明氢氯噻嗪阻断一部分钠和氯离子的重吸收，从而增加随尿排出的钠和水；同时可能增加钾、氢和氯的丢失，并影响钙和尿酸的排泄。这解释了为什么不能只盯着血压，还要结合症状、肾功能和电解质监测。", "en": "The FDA label explains that hydrochlorothiazide blocks part of sodium and chloride reabsorption, increasing sodium and water excretion. It may also increase loss of potassium, hydrogen and chloride and affect calcium and uric-acid excretion. This is why blood pressure alone is not enough: symptoms, kidney function and electrolyte monitoring also matter." }, "checks": [ { "zh": "它不是“普通排水胶囊”，也不是看到水肿、体重或血压变化就能自行多吃或补吃的工具。过度利尿可造成脱水、低血压和电解质紊乱。", "en": "It is not an ordinary water-removal capsule or a tool to increase or repeat yourself because swelling, weight or blood pressure changes. Excessive diuresis can cause dehydration, low blood pressure and electrolyte disturbance." }, { "zh": "氢氯噻嗪片、MICROZIDE 胶囊以及含氢氯噻嗪的复方片是不同产品；共同成分不表示可以按毫克数自行叠加、轮换、拆分或替代。", "en": "Hydrochlorothiazide tablets, MICROZIDE capsules and combination tablets containing hydrochlorothiazide are different products. A shared ingredient does not permit self-combination, rotation, splitting or substitution by milligram numbers." }, { "zh": "网页解释药理路径与说明书风险，不替个人决定目标血压、服用时刻、粒数、漏服补服、饮水或盐摄入、化验频率、停药或换药。", "en": "The site explains the pharmacologic pathway and label risks. It does not decide an individual's target blood pressure, timing, capsule count, missed-use action, fluid or salt intake, laboratory frequency, stopping or switching." } ], "source": { "id": "src_112ef053c229398f", "label": "FDA：MICROZIDE（hydrochlorothiazide）12.5 mg 胶囊美国处方信息（2020-08 修订；标签注明可能不是最新版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020504s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "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": "MICROZIDE", "generic": "氢氯噻嗪胶囊", "dosageFormClass": "氢氯噻嗪 12.5 mg 口服胶囊；不是氢氯噻嗪片，也不是已经含氢氯噻嗪的复方片" }, "labelSource": { "id": "src_112ef053c229398f", "label": "FDA：MICROZIDE（hydrochlorothiazide）12.5 mg 胶囊美国处方信息（2020-08 修订；标签注明可能不是最新版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020504s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_112ef053c229398f", "label": "FDA：MICROZIDE（hydrochlorothiazide）12.5 mg 胶囊美国处方信息（2020-08 修订；标签注明可能不是最新版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020504s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "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." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：MICROZIDE（hydrochlorothiazide）NDA 020504，12.5 mg 口服胶囊；处方药 RLD 与 RS", "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." } }, { "source": { "id": "src_46382e935f7dacef", "label": "DailyMed（NLM）：MICROZIDE 12.5 mg、NDC 52544-622-01、100 粒瓶装历史标签（2011-10 修订；营销结束 2020-08-31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=afbefaff-97c4-4f84-b989-1595f882a885", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_archive", "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." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "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": "MICROZIDE 是氢氯噻嗪 12.5 mg 口服胶囊。它帮助肾脏排出更多钠和水，也可能影响钾、钠、镁、尿酸、血糖与血压。很多复方降压药已经含有氢氯噻嗪；只看品牌名再加一盒单方药可能重复成分。网页先帮助核对完整成分和准确药盒，不提供个人粒数、补服、加减量或换药方案。", "history": "FDA Orange Book 当前数据将 MICROZIDE NDA 020504 的 12.5 mg 口服胶囊列为处方 RLD 与 RS，原始批准日期为 1996-12-27。FDA 2020 年标签是本页的有日期说明书阅读来源，并明确提示它可能不是最新版本；DailyMed 2011 年标签中的 NDC 52544-622-01 已记录营销于 2020-08-31 结束，因此其图片只作历史包装核对。", "sourceDocuments": [ { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：MICROZIDE（hydrochlorothiazide）NDA 020504，12.5 mg 口服胶囊；处方药 RLD 与 RS", "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_112ef053c229398f", "label": "FDA：MICROZIDE（hydrochlorothiazide）12.5 mg 胶囊美国处方信息（2020-08 修订；标签注明可能不是最新版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020504s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_46382e935f7dacef", "label": "DailyMed（NLM）：MICROZIDE 12.5 mg、NDC 52544-622-01、100 粒瓶装历史标签（2011-10 修订；营销结束 2020-08-31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=afbefaff-97c4-4f84-b989-1595f882a885", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_archive", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 020504（MICROZIDE / hydrochlorothiazide 12.5 mg oral capsule）", "approvalTimeline": [ { "date": "1996-12-27", "title": { "zh": "FDA 原始批准", "en": "FDA original approval" }, "detail": { "zh": "Orange Book 当前数据将 MICROZIDE 12.5 mg 口服胶囊与 NDA 020504、RLD/RS 身份相连。", "en": "Current Orange Book data link the MICROZIDE 12.5 mg oral capsule to NDA 020504 and RLD/RS identity." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：MICROZIDE（hydrochlorothiazide）NDA 020504，12.5 mg 口服胶囊；处方药 RLD 与 RS", "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": "2020-08", "title": { "zh": "FDA 有日期处方信息修订", "en": "Dated FDA prescribing-information revision" }, "detail": { "zh": "该文件用于本页说明书放大阅读；文件本身提示可能不是最新批准标签，因此不得单独当作当前包装或全部现行信息。", "en": "This document supports enlarged label reading here; it says it may not be the latest approved label and therefore does not alone establish a current pack or every current statement." }, "source": { "id": "src_112ef053c229398f", "label": "FDA：MICROZIDE（hydrochlorothiazide）12.5 mg 胶囊美国处方信息（2020-08 修订；标签注明可能不是最新版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020504s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2020-08-31", "title": { "zh": "历史 DailyMed NDC 营销结束", "en": "Historical DailyMed NDC marketing end" }, "detail": { "zh": "NDC 52544-622-01 的 100 粒瓶装图片自此只作历史包装核对。", "en": "The NDC 52544-622-01 100-capsule bottle image is used only as a historical pack reference after this date." }, "source": { "id": "src_46382e935f7dacef", "label": "DailyMed（NLM）：MICROZIDE 12.5 mg、NDC 52544-622-01、100 粒瓶装历史标签（2011-10 修订；营销结束 2020-08-31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=afbefaff-97c4-4f84-b989-1595f882a885", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_archive", "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": "Orange Book 当前列示处方 RLD/RS；当前准确 NDC/包装未建立", "en": "Currently listed by the Orange Book as prescription RLD/RS; exact current NDC/pack not established" }, "detail": { "zh": "页面保留产品身份，同时把 2020 标签和旧包装标成有日期资料；不证明任何药店库存或购买资格。", "en": "The page retains product identity while marking the 2020 label and old pack as dated material; it does not establish pharmacy stock 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": "不从美国名称、通用名或 12.5 mg 数字推定当地批准、商品名、包装、原研/仿制关系、供应或可替代性。", "en": "No local approval, trade name, pack, originator/generic relationship, supply or interchangeability is inferred from the U.S. name, generic or 12.5 mg number." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "为什么要特别检查复方药？", "en": "Why should combination medicines be checked carefully?" }, "answer": { "zh": "因为氢氯噻嗪可能已经作为第二或第三种成分写在复方药盒上。再加 MICROZIDE 可能重复同一成分，但是否重复、是否有意安排只能由准确处方和完整药单判断，网页不能替你停掉任何一盒。", "en": "Hydrochlorothiazide may already be listed as the second or third ingredient on a combination pack. Adding MICROZIDE may duplicate that ingredient, but only the exact prescriptions and full medicine list can show whether this is duplication or intentional; the website cannot tell you to stop a pack." } }, { "question": { "zh": "12.5 mg 是一次必须吃一粒吗？", "en": "Does 12.5 mg mean one capsule must be taken each time?" }, "answer": { "zh": "不是。12.5 mg 是每粒标签量，用于识别产品。个人粒数、频次、漏服处理和调整必须按自己的处方、病情、肾功能、电解质和其他药物由专业人员判断。", "en": "No. The 12.5 mg is the labelled amount per capsule for product identification. An individual's capsule count, frequency, missed-use action and adjustment require professional review of the prescription, condition, kidney function, electrolytes and other medicines." } }, { "question": { "zh": "网上的蓝绿色胶囊图就是现在买到的外观吗？", "en": "Is the teal capsule image the appearance of a pack available now?" }, "answer": { "zh": "不能这样理解。本站图片对应 2011 年 DailyMed 历史标签中的 NDC 52544-622-01，营销已于 2020 年结束。当前实际药盒应按其完整文字、NDC/批准信息和目标市场官方记录另行核对。", "en": "No. The image corresponds to NDC 52544-622-01 in a 2011 DailyMed historical label whose marketing ended in 2020. A current pack must be checked separately using all visible text, NDC or approval information and the target market's official record." } } ], "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/microzide/", "en": "https://origindrug.com/en/drugs/microzide/" }, "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." ] }