{ "id": "uloric", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "ULORIC", "generic": "非布司他", "aliases": [ "ULORIC", "febuxostat", "非布司他" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国 ULORIC 非布司他当前公开标签（DailyMed SPL v17；页面 2025-12-24 更新；本档案只建立 NDC 64764-918-30 与 NDC 64764-677-30 两个 30 片瓶装面板）", "dosageFormClass": "口服片：40 mg、80 mg（当前美国公开标签所列；本档案分别展示两个 30 片瓶装面板）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2009（当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Takeda Pharmaceuticals America, Inc. / DailyMed（NLM）当前公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-uloric-febuxostat-tablet-40mg-30-count-bottle-ndc-64764-918-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v17；页面 2025-12-24 更新）", "en": "Current U.S. DailyMed public label (SPL v17; page updated 24 Dec 2025)" }, "dosageForm": { "zh": "ULORIC 非布司他口服片", "en": "ULORIC febuxostat oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-918-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 40 mg；30 片瓶装", "en": "40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=uloric-02.jpg&setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "非布司他", "en": "febuxostat" }, "value": 40, "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, initiation, adjustment or switching rule" } } ], "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": "2026-08-25", "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": "浅绿色至绿色", "en": "light green to green" }, "shape": { "zh": "圆片", "en": "round tablet" }, "imprint": "TAP / 40", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17，页面 2025-12-24 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-uloric-febuxostat-tablet-80mg-30-count-bottle-ndc-64764-677-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v17；页面 2025-12-24 更新）", "en": "Current U.S. DailyMed public label (SPL v17; page updated 24 Dec 2025)" }, "dosageForm": { "zh": "ULORIC 非布司他口服片", "en": "ULORIC febuxostat oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-677-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 80 mg；30 片瓶装", "en": "80 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=uloric-03.jpg&setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "非布司他", "en": "febuxostat" }, "value": 80, "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, initiation, adjustment or switching rule" } } ], "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": "2026-08-25", "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": "浅绿色至绿色", "en": "light green to green" }, "shape": { "zh": "泪滴形片", "en": "teardrop-shaped tablet" }, "imprint": "TAP / 80", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17，页面 2025-12-24 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-uloric-febuxostat-tablet-40mg-30-count-bottle-ndc-64764-918-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=uloric-02.jpg&setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&type=img", "alt": "ULORIC 非布司他在美国 DailyMed 当前公开标签中的 40 mg、NDC 64764-918-30、30 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（SPL v17；页面 2025-12-24 更新）", "presentation": "ULORIC 非布司他：每片 40 mg，NDC 64764-918-30，30 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 ULORIC、非布司他 40 mg、NDC 64764-918-30 与 30 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 80 mg、其他包装、其他市场、实际可得性、原研身份或可替代性。毫克数和包装数字不是网页给个人的片数、开始、停用、联用或换药指令。", "source": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17，页面 2025-12-24 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ULORIC 说明书放大阅读：40 mg、80 mg、NDC 与瓶装先用来核对准确片剂身份", "en": "ULORIC label reading: 40 mg, 80 mg, NDC and bottle first identify the exact tablet" }, "summary": { "zh": "本模块只阅读美国 DailyMed 当前公开标签中的 ULORIC、非布司他、40 mg 或 80 mg 每片标签量、准确 NDC、30 片瓶装和外形文字线索。它不提供个人片数、起始、递增、漏用补救、停用、联用、换药或购买方案。", "en": "This module reads only ULORIC, febuxostat, the 40 mg or 80 mg labelled amount per tablet, exact NDC, 30-tablet bottle and appearance text in the current U.S. DailyMed public label. It provides no individual tablet count, initiation, increase, missed-use remedy, stopping, co-use, switching or purchase plan." }, "checks": [ { "zh": "先把 ULORIC、非布司他、40 mg 或 80 mg、实际 NDC、30 片瓶装、口服片和目标市场一起核对。只看到“非布司他”或一个 mg 数字，不能证明另一强度、另一包装、另一品牌或另一市场产品相同。", "en": "Check ULORIC, febuxostat, 40 mg or 80 mg, the actual NDC, 30-tablet bottle, oral-tablet form and target market together. Seeing only “febuxostat” or one mg number does not prove that another strength, package, brand or market product is the same." }, { "zh": "40 mg、80 mg 和“30 片瓶装”是两个准确标签面板的身份文字，不是每天该吃几片、何时加减、是否漏用补回或是否可自行换到另一盒的说明。任何实际使用问题应带现行药盒、处方和完整药单请药师或开方团队核对。", "en": "The 40 mg, 80 mg and “30-tablet bottle” wording identifies two exact label panels; it does not say how many tablets to use, when to adjust, whether to make up a missed use or whether another pack can be self-switched. Take the current pack, prescription and full medicine list to a pharmacist or prescribing team for any real-use question." }, { "zh": "当前标签含有关于心血管死亡的加框警告，并把既往心血管情况和全部药单置于专业核对范围。该警告是阅读和求助线索，不让网页判断某个人能否继续、应否开始、停止或改用任何降尿酸产品。", "en": "The current label contains a boxed warning about cardiovascular death and places cardiovascular history and the complete medicine list within professional review. This warning is a reading and help-seeking cue; it does not let a webpage decide whether an individual should continue, start, stop or change any urate-lowering product." }, { "zh": "标签列出与硫唑嘌呤或巯嘌呤的禁忌；还应由药师或医生核对所有处方药、非处方药、补充剂、既往反应和准确产品。不要因看到相互作用或警告文字自行加、停、换、错开或补用任何药物。", "en": "The label lists contraindications with azathioprine or mercaptopurine; a pharmacist or clinician should also review every prescription medicine, OTC product, supplement, prior reaction and the exact product. Do not self-add, stop, switch, separate or make up any medicine because an interaction or warning appears on a webpage." } ], "source": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Boxed Warning, Contraindications and Patient Counseling；Takeda Pharmaceuticals America；SPL v17）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "非布司他怎样在标签中被描述：黄嘌呤氧化酶抑制路径，不是个人用药规则", "en": "How febuxostat is described in the label: a xanthine-oxidase inhibition pathway, not an individual-use rule" }, "summary": { "zh": "当前美国标签将非布司他描述为黄嘌呤氧化酶抑制剂。这个机制帮助读者理解药物类别和尿酸生成相关的标签用语；它不诊断关节症状、预测个人尿酸变化、决定片数，或说明能否与别嘌醇、秋水仙碱或其他产品自行合并、替换或轮换。", "en": "The current U.S. label describes febuxostat as a xanthine oxidase inhibitor. This mechanism helps readers understand the drug class and label language related to uric-acid production; it does not diagnose joint symptoms, predict an individual's uric-acid change, determine tablet count or establish self-combination, replacement or alternation with allopurinol, colchicine or another product." }, "checks": [ { "zh": "“黄嘌呤氧化酶抑制”解释的是标签中的一个作用路径，不是从网页判断关节痛、红肿、尿酸检查结果或其他不适原因的工具。", "en": "“Xanthine oxidase inhibition” explains one pathway in the label; it is not a website tool for deciding the cause of joint pain, redness, a uric-acid test result or another symptom." }, { "zh": "同样与尿酸、痛风、炎症或黄嘌呤氧化酶相关的产品，不能因名称、类别或机制词相近就自行叠加、轮换、替代或按 mg 换算。", "en": "Products also related to uric acid, gout, inflammation or xanthine oxidase cannot be self-combined, alternated, substituted or milligram-converted because their names, classes or mechanism terms seem similar." }, { "zh": "机制说明不能决定是否需要某种治疗、何时开始、持续多久、是否漏用补回、是否停用或如何处理急性问题。实际问题必须回到准确产品的目标市场现行标签和专业人员。", "en": "A mechanism explanation cannot decide whether a treatment is needed, when to start, how long to continue, whether to make up a missed use, whether to stop or how to handle an acute concern. Real questions must return to the current target-market label for the exact product and a professional." } ], "source": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Clinical Pharmacology；Takeda Pharmaceuticals America；SPL v17）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ULORIC", "generic": "非布司他", "dosageFormClass": "口服片：40 mg、80 mg（当前美国公开标签所列；本档案分别展示两个 30 片瓶装面板）" }, "labelSource": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17，页面 2025-12-24 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17，页面 2025-12-24 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "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": "2026-08-25", "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": "2026-08-25", "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 的当前 ULORIC 公开标签将其列为非布司他口服片，列有 40 mg、80 mg 两种片剂及对应的 30 片瓶装面板。本页帮助核对商品名、通用名、每片标签量、准确 NDC、外形线索、目标市场和原始标签；它不把毫克数、包装数字、警告或相互作用文字转成个人片数、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: 2009。该年份和页面状态只定位所引美国标签；同一通用名的其他品牌、其他强度、其他包装、其他国家/地区版本或其他降尿酸产品，均须按准确产品和目标市场现行资料分别核对。", "sourceDocuments": [ { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17，页面 2025-12-24 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } ], "applicationNumber": "NDA 021856", "approvalTimeline": [ { "date": "2009", "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 ULORIC 标签列示 Initial U.S. Approval: 2009。该年份只定位所引美国标签历史，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 ULORIC label lists Initial U.S. Approval: 2009. This year only locates the cited U.S. label history; 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_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, { "date": "2025-12-24", "title": { "zh": "DailyMed 当前公开标签页面更新", "en": "Current DailyMed public-label page updated" }, "detail": { "zh": "DailyMed 将该 ULORIC 当前公开标签页面的 Updated 日期列为 2025-12-24，版本为 SPL v17。本页只分别展示 40 mg、NDC 64764-918-30 与 80 mg、NDC 64764-677-30 的 30 片瓶装面板；不据此建立实际在售、库存、购买、个人片数、联用、停用、换药或其他市场状态。", "en": "DailyMed lists 24 Dec 2025 as the Updated date for this current ULORIC public-label page, version SPL v17. This page separately displays the 30-tablet bottle panels for 40 mg/NDC 64764-918-30 and 80 mg/NDC 64764-677-30; it does not establish actual availability, stock, purchase, individual tablet count, co-use, stopping, switching or another-market status." }, "source": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17，页面 2025-12-24 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与两组准确 30 片瓶装面板", "en": "Current public label and two exact 30-tablet bottle panels linked" }, "detail": { "zh": "本页分别展示 ULORIC 非布司他 40 mg、NDC 64764-918-30 与 80 mg、NDC 64764-677-30 的 30 片瓶装。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、开始、停用、联用、换药或可替代性。", "en": "This page separately displays the ULORIC febuxostat 40 mg/NDC 64764-918-30 and 80 mg/NDC 64764-677-30 30-tablet bottles. It does not authenticate a product or establish actual availability, stock, purchase, individual tablet count, initiation, stopping, co-use, switching 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、NDA、NDC、英文品牌、包装图或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须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, NDA, NDC, English brand, package image or label entity; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "40 mg、80 mg 与 30 片瓶装能否用来自己决定片数、换到另一种强度或另一种降尿酸产品？", "en": "Can 40 mg, 80 mg and a 30-tablet bottle be used to decide my own tablet count or switch to another strength or urate-lowering product?" }, "answer": { "zh": "不能。这些字段只识别所引美国标签中的准确 ULORIC 片剂和包装。共同通用名、相近毫克数、包装照片或同属降尿酸领域，均不建立自行开始、增加、补用、停用、联用、轮换或替代关系；请带现行药盒、处方和完整药单请药师或开方团队复核。", "en": "No. These fields only identify the exact ULORIC tablets and packages in the cited U.S. label. A shared generic name, a nearby milligram number, a package photo or the same urate-lowering area does not establish self-initiation, increase, make-up use, stopping, co-use, alternation or substitution; take the current pack, prescription and complete medicine list to a pharmacist or prescribing team for review." } }, { "question": { "zh": "为什么页面强调心血管警告和完整药单，却不告诉我是否该改药？", "en": "Why does the page emphasise the cardiovascular warning and complete medicine list without telling me whether to change medicine?" }, "answer": { "zh": "这是当前美国标签中加框警告、禁忌和相互作用段落的阅读入口，不是个体化风险判断或治疗决策。出现急性严重不适或对现行处方有担忧时，请使用当地医疗支持；药师或医生需要结合准确产品、病史、检查和完整药单逐项复核。", "en": "It is a reading entry point for the current U.S. label's boxed warning, contraindications and interaction sections, not an individual risk assessment or treatment decision. For an acute serious concern or worry about the current prescription, use local medical support; a pharmacist or clinician needs the exact product, history, tests and complete medicine list for item-by-item 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/uloric/", "en": "https://origindrug.com/en/drugs/uloric/" }, "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." ] }