{ "id": "zyloprim", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "ZYLOPRIM", "generic": "别嘌醇", "aliases": [ "ZYLOPRIM", "allopurinol", "别嘌醇" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国当前 ZYLOPRIM 别嘌醇公开标签（处方信息 2025-01 修订；DailyMed SPL v10）", "dosageFormClass": "口服片：100 mg、200 mg、300 mg（当前美国标签所列；本档案分别展示三种 90 片瓶装面板）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1966（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Casper Pharma LLC / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "allopurinol injection", "注射用别嘌醇" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-zyloprim-allopurinol-tablet-100mg-90-count-bottle-ndc-70199-031-90", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-01 修订；DailyMed SPL v10", "en": "Prescribing information revised Jan 2025; DailyMed SPL v10" }, "dosageForm": { "zh": "ZYLOPRIM 别嘌醇口服片", "en": "ZYLOPRIM allopurinol oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 70199-031-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 100 mg；90 片瓶装", "en": "100 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?archiveid=867966&name=allopurinol-100mg-90ct.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "别嘌醇", "en": "allopurinol" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、起始、加减或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, start, adjustment or switching rule" } } ], "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": null, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "带斜边的凸起六角片", "en": "beveled raised hexagonal tablet" }, "imprint": "ZYLOPRIM 100", "scoreStatus": "functionally_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zyloprim-allopurinol-tablet-200mg-90-count-bottle-ndc-70199-032-90", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-01 修订；DailyMed SPL v10", "en": "Prescribing information revised Jan 2025; DailyMed SPL v10" }, "dosageForm": { "zh": "ZYLOPRIM 别嘌醇口服片", "en": "ZYLOPRIM allopurinol oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 70199-032-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 200 mg；90 片瓶装", "en": "200 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?archiveid=867966&name=allopurinol-200mg-90ct.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "别嘌醇", "en": "allopurinol" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、起始、加减或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, start, adjustment or switching rule" } } ], "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": null, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "双凸圆片", "en": "biconvex round tablet" }, "imprint": "ZYLOPRIM / 200", "scoreStatus": "functionally_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zyloprim-allopurinol-tablet-300mg-90-count-bottle-ndc-70199-033-90", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-01 修订；DailyMed SPL v10", "en": "Prescribing information revised Jan 2025; DailyMed SPL v10" }, "dosageForm": { "zh": "ZYLOPRIM 别嘌醇口服片", "en": "ZYLOPRIM allopurinol oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 70199-033-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 300 mg；90 片瓶装", "en": "300 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?archiveid=867966&name=allopurinol-300mg-90ct.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "别嘌醇", "en": "allopurinol" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、起始、加减或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, start, adjustment or switching rule" } } ], "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": null, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "带斜边的凸起六角片", "en": "beveled raised hexagonal tablet" }, "imprint": "ZYLOPRIM 300", "scoreStatus": "functionally_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-zyloprim-allopurinol-tablet-100mg-90-count-bottle-ndc-70199-031-90", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?archiveid=867966&name=allopurinol-100mg-90ct.jpg", "alt": "ZYLOPRIM 别嘌醇在美国 DailyMed 当前公开标签中的 100 mg、NDC 70199-031-90、90 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "处方信息 2025-01 修订；DailyMed SPL v10", "presentation": "ZYLOPRIM 别嘌醇：每片 100 mg，NDC 70199-031-90，90 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 ZYLOPRIM、别嘌醇 100 mg、NDC 70199-031-90 与 90 片瓶装。它只帮助核对品牌、通用名、每片标签量、口服片、包装数量、外形线索与来源；不用于鉴定真伪，也不证明 200 mg、300 mg、其他包装、其他市场、当前可得性、原研身份或可替代性。标签所列功能性刻痕与毫克数均不是网页给个人的掰开、片数、开始、停用、联用或换药指令。", "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZYLOPRIM 说明书放大阅读：100、200、300 mg 与刻痕先是片剂身份，不是“该吃几颗”", "en": "ZYLOPRIM label reading: 100, 200 and 300 mg plus scoring identify a tablet; they do not answer “how many tablets”" }, "summary": { "zh": "本模块以美国 DailyMed 当前公开标签为入口，帮助核对 ZYLOPRIM、别嘌醇、每片标签量、准确 NDC、90 片瓶装、片剂外形和目标市场。它不提供个人片数、起始、递增、漏用补救、掰开、停用、联用或换药方案。", "en": "This module uses the current U.S. DailyMed public label to check ZYLOPRIM, allopurinol, labelled amount per tablet, exact NDC, 90-tablet bottle, tablet appearance and target market. It provides no individual tablet count, initiation, increase, missed-use remedy, splitting, stopping, combination or switching plan." }, "checks": [ { "zh": "先把 ZYLOPRIM、别嘌醇、100/200/300 mg、实际 NDC、口服片和目标市场一起核对。毫克数是这一个准确片剂的标签量，不是任何人每天该吃几片的答案；同一通用名、另一种强度或另一种剂型也不能只按数字自行换算。", "en": "Check ZYLOPRIM, allopurinol, 100/200/300 mg, the actual NDC, oral-tablet form and target market together. Milligrams are the labelled amount in this exact tablet, not an answer to how many tablets anyone should take; a shared generic name, another strength or another dosage form cannot be self-converted from a number." }, { "zh": "当前标签描述三种片剂的外形、刻字和功能性刻痕。这些是产品身份线索，不是照片鉴定真伪的方法，也不是“可以自行掰半、补用或调整”的授权。实际包装、处方或吞咽情况与页面不同，应带着药盒向药师或开方团队核对。", "en": "The current label describes shape, imprint and functional scoring for the three tablet presentations. These are product-identity clues, not a way to authenticate a photograph or permission to self-split, make up or adjust use. If the actual pack, prescription or swallowing situation differs, take the pack to a pharmacist or prescribing team." }, { "zh": "标签将 HLA-B*58:01 与别嘌醇严重超敏反应风险联系起来，并说明检验的意义取决于开始治疗前后的情况与人群背景。网页不建议所有人做筛查，也不把阳性、阴性或既有基因报告变成个人能否开始、继续、停用或换药的结论；请带原始报告、实际药盒和完整药单请专业人员解释。", "en": "The label links HLA-B*58:01 with risk of severe allopurinol hypersensitivity and explains that the meaning of testing depends on timing around treatment and population context. This page neither recommends universal screening nor turns a positive, negative or existing genetic report into a conclusion about starting, continuing, stopping or switching; take the original report, actual pack and complete medicine list to a professional." }, { "zh": "当前标签列出噻嗪类利尿剂、氨苄西林、阿莫西林、硫唑嘌呤、巯嘌呤等需要特别核对的合并药线索。它不是一个可自行逐项停、加、错开或换药的清单；请把处方药、非处方药、补充剂和近期用药变化一并交给药师或医生。出现新的皮疹、水疱、口腔/眼部不适、发热、面唇肿胀、呼吸困难或其他急性严重问题时，优先使用当地紧急医疗与开方团队渠道，不要依赖网页自行处理或自行重新开始用药。", "en": "The current label flags thiazide diuretics, ampicillin, amoxicillin, azathioprine and mercaptopurine among co-medications requiring particular review. It is not a checklist for self-stopping, adding, spacing or switching products; give prescription medicines, OTC products, supplements and recent changes together to a pharmacist or clinician. With a new rash, blisters, mouth/eye discomfort, fever, lip/facial swelling, breathing difficulty or another acute severe concern, prioritise local urgent medical and prescribing-team pathways rather than self-managing from a webpage or self-restarting treatment." } ], "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Warnings, Drug Interactions and Patient Counseling；Casper Pharma；SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "别嘌醇怎样起作用：它影响尿酸生成路径中的黄嘌呤氧化酶", "en": "How allopurinol works: it affects xanthine oxidase in a uric-acid production pathway" }, "summary": { "zh": "当前 ZYLOPRIM 标签将别嘌醇描述为黄嘌呤氧化酶抑制剂，并说明该酶参与次黄嘌呤、黄嘌呤到尿酸的转化；其代谢物奥昔嘌醇也抑制该酶。这个机制帮助读者理解药物作用路径，不诊断痛风、结石、关节痛或其他症状，也不决定个人是否适用、片数、起始、联用或换药。", "en": "The current ZYLOPRIM label describes allopurinol as a xanthine-oxidase inhibitor and explains that the enzyme participates in conversion of hypoxanthine and xanthine to uric acid; its metabolite oxypurinol also inhibits the enzyme. This explains a drug-action pathway, not gout, stones, joint pain or another symptom, and it does not decide individual suitability, tablet count, initiation, combination or switching." }, "checks": [ { "zh": "“影响尿酸生成路径”不等于任何关节痛、红肿、肾结石、化验数字或其他症状都由同一原因造成，也不表示网页可判断是否需要别嘌醇。诊断、检查、肾功能、完整药单和准确产品标签都必须由专业人员放在一起判断。", "en": "“Affects a uric-acid production pathway” does not mean every joint pain, redness, stone, laboratory number or other symptom has the same cause, or that a webpage can decide whether allopurinol is needed. Diagnosis, tests, kidney context, the complete medicine list and the exact product label must be considered together by a professional." }, { "zh": "同样影响尿酸、嘌呤或黄嘌呤氧化酶的产品，或名称中都含“尿酸”“嘌呤”，都不能证明可自行叠加、轮换、以 mg 等量换算或从一盒换到另一盒。不同品牌、强度、剂型、市场和合并药物需要逐项核对。", "en": "A product that also affects uric acid, purines or xanthine oxidase, or whose name includes similar words, does not prove that products can be self-combined, alternated, milligram-converted or replaced from one pack to another. Brand, strength, dosage form, market and co-medications require item-by-item review." }, { "zh": "机制不能决定基因检测、饮食、补液、化验频率、治疗时长、是否停用或如何处理漏用。若已有基因或检验报告，带原始资料、实际药瓶和完整药单与药师或医生讨论其是否与当前处方相关。", "en": "Mechanism cannot decide genetic testing, diet, fluid intake, testing frequency, treatment duration, whether to stop or how to handle missed use. If a genetic or laboratory report already exists, discuss whether it relates to the current prescription with a pharmacist or clinician using the original materials, actual bottle and complete medicine list." } ], "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Clinical Pharmacology；Casper Pharma；SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ZYLOPRIM", "generic": "别嘌醇", "dosageFormClass": "口服片：100 mg、200 mg、300 mg（当前美国标签所列；本档案分别展示三种 90 片瓶装面板）" }, "labelSource": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "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": "2026-08-20", "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": "美国 DailyMed 的 ZYLOPRIM 公开标签将其列为别嘌醇口服片，列有 100 mg、200 mg、300 mg 三种片剂。本页帮助核对商品名、通用名、每片标签量、准确 90 片瓶装面板、片剂外形线索、目标市场和标签版本；它不把任何毫克数字、刻痕、基因结果或相互作用文字转成个人片数、掰开、开始、停用、联用、换药或购买建议。", "history": "当前美国公开标签列示 Initial U.S. Approval: 1966，并在当前版本中列示 NDA 016084。这个档案只定位这份美国公开标签；同一通用名、不同品牌、不同强度、不同国家/地区、口服与注射产品或其他版本均须分别按当地现行资料核对。", "sourceDocuments": [ { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 016084", "approvalTimeline": [ { "date": "1966", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 ZYLOPRIM 标签列示 Initial U.S. Approval: 1966。该年份只定位这一美国公开标签档案，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The current ZYLOPRIM label lists Initial U.S. Approval: 1966. This year locates this U.S. public-label archive only; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-01-09", "title": { "zh": "当前标签的有效日期与 SPL v10", "en": "Current label effective date and SPL v10" }, "detail": { "zh": "当前 ZYLOPRIM 标签页面列示处方信息修订于 2025-01、Effective Time 为 2025-01-09、Version 10。本页分别展示 100 mg、200 mg、300 mg 的 90 片瓶装面板；不据此建立实际在售、库存、个人片数、掰开、开始、停用、联用或换药结论。", "en": "The current ZYLOPRIM label page lists a Jan 2025 revision, effective time 9 Jan 2025 and Version 10. This page separately displays 90-tablet bottle panels for 100 mg, 200 mg and 300 mg; it does not establish actual availability, stock, individual tablet count, splitting, initiation, stopping, co-use or switching." }, "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与三个准确 90 片瓶装面板", "en": "Current public label and three exact 90-tablet bottle panels linked" }, "detail": { "zh": "本页面板分别对应 NDC 70199-031-90（100 mg）、NDC 70199-032-90（200 mg）和 NDC 70199-033-90（300 mg）。它们不用于鉴定真伪，也不建立实际在售、库存、个人片数、掰开、开始、停用、联用或可替代性。", "en": "The panels correspond respectively to NDC 70199-031-90 (100 mg), NDC 70199-032-90 (200 mg) and NDC 70199-033-90 (300 mg). They do not authenticate a product or establish actual availability, stock, individual tablet count, splitting, initiation, stopping, co-use or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、NDC 或品牌名称推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；任何市场版本均需按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDC or brand name; every market version needs separate checking against current local regulatory information." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "ZYLOPRIM 100、200、300 mg 或带刻痕的片剂，是否表示可以自行掰开、增减或从一盒换到另一盒？", "en": "Do ZYLOPRIM 100, 200 or 300 mg tablets, or a scored tablet, mean that they can be self-split, adjusted or exchanged between packs?" }, "answer": { "zh": "不能。毫克数、外形、刻字和功能性刻痕都是准确片剂的标签身份信息，不是个人片数、掰开、补用、开始、停用或换药规则。应带实际药瓶、处方和完整药单让药师或开方团队核对。", "en": "No. Milligrams, shape, imprint and functional scoring are label-identity information for an exact tablet, not rules for individual tablet count, splitting, make-up use, initiation, stopping or switching. Take the actual bottle, prescription and complete medicine list to a pharmacist or prescribing team for review." } }, { "question": { "zh": "HLA-B*58:01 相关提示是否表示每个人都应做基因筛查，或可以凭报告自行开始/停用别嘌醇？", "en": "Does the HLA-B*58:01 information mean that everyone should be screened, or that a report can be used to self-start or stop allopurinol?" }, "answer": { "zh": "不表示。当前标签把该标记与严重超敏反应风险联系起来，但检验是否相关需结合治疗阶段、人群背景、肾功能、既往反应、完整药单和准确处方由专业人员判断。页面不建议普遍筛查，也不将任何报告替代临床复核。", "en": "No. The current label links this marker with severe hypersensitivity risk, but whether testing is relevant requires professional assessment of treatment stage, population context, kidney function, prior reactions, complete medicine list and the exact prescription. This page does not recommend universal screening or use any report in place of clinical review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zyloprim/", "en": "https://origindrug.com/en/drugs/zyloprim/" }, "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." ] }