{ "id": "xanax", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Xanax", "generic": "阿普唑仑", "aliases": [ "alprazolam" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国有日期公开标签（页面 2023-01 更新；本页分别保留四种 100 片瓶装身份；不代表当前供应或可得性）", "dosageFormClass": "口服片剂（C-IV；0.25 mg、0.5 mg、1 mg、2 mg；有日期公开标签所列；四种准确 100 片瓶装分别建立；不与 XANAX XR 混同）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1981（FDA 与 DailyMed 标签所列美国初始批准）", "archiveSponsorText": "Pharmacia & Upjohn / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-xanax-alprazolam-tablet-0-25mg-100-bottle-ndc-0009002901", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2023-01 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated Jan 2023); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "XANAX 阿普唑仑口服片（C-IV；非 XANAX XR）", "en": "XANAX alprazolam oral tablet (C-IV; not XANAX XR)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0029-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿普唑仑 0.25 mg；100 片瓶装", "en": "Alprazolam 0.25 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&setid=388e249d-b9b6-44c3-9f8f-880eced0239f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿普唑仑", "en": "alprazolam" }, "value": 0.25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形片；标签列示 2 等分刻痕", "en": "oval tablet; label lists 2-piece score" }, "imprint": "XANAX / 0 / 25", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-xanax-alprazolam-tablet-0-5mg-100-bottle-ndc-0009005501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2023-01 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated Jan 2023); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "XANAX 阿普唑仑口服片（C-IV；非 XANAX XR）", "en": "XANAX alprazolam oral tablet (C-IV; not XANAX XR)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0055-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿普唑仑 0.5 mg；100 片瓶装", "en": "Alprazolam 0.5 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=388e249d-b9b6-44c3-9f8f-880eced0239f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿普唑仑", "en": "alprazolam" }, "value": 0.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色（桃色）", "en": "orange (peach)" }, "shape": { "zh": "椭圆形片；标签列示 2 等分刻痕", "en": "oval tablet; label lists 2-piece score" }, "imprint": "XANAX / 0 / 5", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-xanax-alprazolam-tablet-1mg-100-bottle-ndc-0009009001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2023-01 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated Jan 2023); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "XANAX 阿普唑仑口服片（C-IV；非 XANAX XR）", "en": "XANAX alprazolam oral tablet (C-IV; not XANAX XR)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0090-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿普唑仑 1 mg；100 片瓶装", "en": "Alprazolam 1 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=388e249d-b9b6-44c3-9f8f-880eced0239f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿普唑仑", "en": "alprazolam" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆形片；标签列示 2 等分刻痕", "en": "oval tablet; label lists 2-piece score" }, "imprint": "XANAX / 1 / 0", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-xanax-alprazolam-tablet-2mg-100-bottle-ndc-0009009401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2023-01 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated Jan 2023); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "XANAX 阿普唑仑口服片（C-IV；非 XANAX XR）", "en": "XANAX alprazolam oral tablet (C-IV; not XANAX XR)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0094-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿普唑仑 2 mg；100 片瓶装", "en": "Alprazolam 2 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-05.jpg&setid=388e249d-b9b6-44c3-9f8f-880eced0239f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿普唑仑", "en": "alprazolam" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形（长圆形）片；标签列示 4 等分刻痕", "en": "oval (oblong) tablet; label lists 4-piece score" }, "imprint": "XANAX / 2", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-xanax-alprazolam-tablet-0-5mg-100-bottle-ndc-0009005501", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=388e249d-b9b6-44c3-9f8f-880eced0239f&type=img", "alt": "XANAX 0.5 mg 阿普唑仑口服片在美国 DailyMed 公开标签中的 Pfizer 100 片包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Pharmacia & Upjohn，2023-01 更新）", "presentation": "XANAX 阿普唑仑 0.5 mg、NDC 0009-0055-01、100 片瓶装面板（有日期公开标签所列）。", "notice": "此图只对应美国 DailyMed 有日期公开标签中的 XANAX、阿普唑仑 0.5 mg、NDC 0009-0055-01 与 100 片瓶装。页面另将 0.25 mg、1 mg、2 mg 的准确 100 片瓶装分开列出；刻痕只描述标签外观，绝不表示可以自行掰开、减量、停用、联用或换药。它不用于鉴定真伪；标签产品数据存在营销结束日期，因此本页不证明当前供应、在售、原研身份、目标市场批准或可售资格。", "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "XANAX 说明书放大阅读：镇静药不能按感觉自行加减或突然停用", "en": "XANAX label reading: a sedating medicine is not adjusted by feeling or stopped suddenly" }, "summary": { "zh": "本模块以 FDA 2023 美国标签为阅读入口，帮助阅读 XANAX 的产品身份、镇静风险、联用边界和停用警示；它不判断个人是否适合使用、应服几片、如何减量或能否替换另一种精神科药物。", "en": "This module uses the 2023 U.S. FDA label as a reading entry point. It helps read XANAX product identity, sedation risk, combination boundaries and discontinuation warnings; it does not decide individual suitability, tablet count, tapering or replacement with another psychiatric medicine." }, "checks": [ { "zh": "先核对 XANAX、阿普唑仑、准确剂型、每片标示强度和目标市场。相同的“助眠/镇静/抗焦虑”用途描述，不能证明另一种药、另一种强度或另一种缓释制剂可以自行替换。", "en": "Check XANAX, alprazolam, the exact dosage form, labelled strength per tablet and target market first. A shared “sleep/sedation/anxiety” description does not prove another medicine, strength or extended-release form can be self-substituted." }, { "zh": "FDA 标签对与阿片类、酒精或其他中枢神经系统抑制性药物同用提出重要警示。家中同时有止痛、止咳、助眠、抗过敏、饮酒或多种精神科药物时，应把全部药单和实际使用情况交由药师或医生核对。", "en": "The FDA label carries important warnings about use with opioids, alcohol or other central-nervous-system depressants. With pain, cough, sleep, allergy, alcohol or multiple psychiatric products at home, have a pharmacist or clinician review the complete list and actual use." }, { "zh": "标签提示有依赖、滥用、误用及突然减少或停止后的风险。不要因为感觉好一些、困倦，或担心副作用就自行加量、借给他人、隔天乱换或突然停用；减量和停用需要由开方团队制定。", "en": "The label warns about dependence, abuse, misuse and risks after abrupt reduction or discontinuation. Do not self-increase, share, irregularly alternate or suddenly stop because of feeling better, drowsiness or concern about adverse effects; tapering and discontinuation need a plan from the prescribing team." }, { "zh": "高龄、跌倒、呼吸问题、意识改变或与多种药物并用时风险评估更不能只靠网页。出现严重嗜睡、呼吸变慢、意识异常或其他急性情况时，应按当地急救和医疗指引及时处理。", "en": "With older age, falls, breathing problems, altered awareness or multiple medicines, risk assessment cannot come from a webpage alone. For severe drowsiness, slowed breathing, altered consciousness or another acute concern, use local emergency and medical guidance promptly." } ], "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新；Warnings and Precautions）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿普唑仑怎样起作用：它增强 GABA 介导的抑制性信号", "en": "How alprazolam works: it enhances GABA-mediated inhibitory signalling" }, "summary": { "zh": "FDA 标签将阿普唑仑描述为苯二氮䓬类药物，并说明其通过苯二氮䓬受体部位增强 GABA 介导的抑制作用。这个机制用于理解为何镇静、联用和停用问题需要谨慎；它不说明谁应使用、服几片或如何减量。", "en": "The FDA label describes alprazolam as a benzodiazepine and says it enhances GABA-mediated inhibition at benzodiazepine receptor sites. This helps explain why sedation, combination and discontinuation need care; it does not say who should use it, how many tablets to take or how to taper." }, "checks": [ { "zh": "“增强抑制性信号”不使任何人可以按感觉自行加量，或把镇静当成疗效指标。困倦、跌倒、呼吸问题与全部联用药都需专业人员按实际情况评估。", "en": "“Enhancing inhibitory signalling” does not let anyone self-increase use by feeling or treat sedation as an efficacy marker. Drowsiness, falls, breathing concerns and all co-medications need professional assessment in the actual context." }, { "zh": "机制解释不了不同苯二氮䓬类或其他精神科药物之间的个人换算或替代。药名相近、用途相似或同样会困，都不足以建立可自行换药的依据。", "en": "Mechanism does not provide individual conversion or substitution between benzodiazepines or other psychiatric medicines. Similar names, uses or drowsiness do not establish a basis for self-switching." }, { "zh": "长期使用、减量、突然停用和与酒精、阿片类或其他镇静药联用的问题，都需要回到准确产品的现行标签、完整药单和开方团队，而不是从药理名词推断。", "en": "Long-term use, tapering, abrupt discontinuation and combinations with alcohol, opioids or other sedatives must return to the current label for the exact product, the complete medicine list and the prescribing team, not be inferred from pharmacology terms." } ], "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Xanax", "generic": "阿普唑仑", "dosageFormClass": "口服片剂（C-IV；0.25 mg、0.5 mg、1 mg、2 mg；有日期公开标签所列；四种准确 100 片瓶装分别建立；不与 XANAX XR 混同）" }, "labelSource": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "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": "2026-08-23", "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_ca630b8f06f82f9b", "label": "FDA：XANAX 2023 美国标签档案（NDA 018276）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018276s059lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "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": "2026-08-23", "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": [ { "id": "fda-2020-benzodiazepine-boxed-warning-alprazolam-xanax-safety-communication", "issuedAt": "2020-09-23", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：包括阿普唑仑／Xanax 的苯二氮䓬类黑框警告更新", "en": "FDA Drug Safety Communication: Boxed Warning update for benzodiazepines including alprazolam/Xanax" }, "summary": { "zh": "FDA 于 2020-09-23 发布苯二氮䓬类药物安全通讯，产品表明确列出 alprazolam／Xanax 与 Xanax XR。公告要求更新美国黑框警告，以一致说明滥用、误用、成瘾、躯体依赖和戒断反应等风险，并提示与阿片类、酒精或其他中枢神经系统抑制物同用时可能增加严重风险。这是美国、特定日期的类别监管通讯；它不能用来判断某个人是否依赖、是否发生相互作用，或支持自行骤停、加减、轮换、与其他镇静产品同服或替换。请把所有处方药、非处方药、酒精及其他物质列入同一张清单，由开方团队或药师核对；出现呼吸困难、癫痫发作或其他严重不适时应立即使用当地紧急医疗支持。", "en": "On 2020-09-23, FDA issued a benzodiazepine Drug Safety Communication whose product table explicitly lists alprazolam/Xanax and Xanax XR. It required updated U.S. Boxed Warnings to describe risks of abuse, misuse, addiction, physical dependence and withdrawal reactions consistently, and notes that use with opioids, alcohol or other central-nervous-system depressants can increase serious risks. This is a dated U.S. class regulatory communication; it cannot determine whether a person has dependence or an interaction, or support self-directed abrupt stopping, dose changes, alternating, combining with another sedating product or substitution. Put all prescriptions, non-prescription medicines, alcohol and other substances on one list for the prescribing team or pharmacist to review; trouble breathing, seizures or other severe symptoms require immediate local emergency support." }, "source": { "id": "src_7b1f9cb057bf46dc", "label": "FDA：2020-09-23 苯二氮䓬类黑框警告更新药物安全通讯（明确列出 alprazolam／Xanax）", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-class", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "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": "DailyMed 的有日期 XANAX（alprazolam）美国公开标签列有 0.25 mg、0.5 mg、1 mg、2 mg 口服片。本页分别建立四种 100 片瓶装的品牌、通用名、每片标示量、NDC、标签所列外观线索与一手来源核对卡；受管制药品的包装数字、颜色或刻痕不生成个人片数、分割、减量、停用、联用、替代、购买或可售资格结论。", "history": "本页仅对应有日期美国公开标签中的 XANAX 0.25 mg（NDC 0009-0029-01）、0.5 mg（0009-0055-01）、1 mg（0009-0090-01）和 2 mg（0009-0094-01）四种 100 片瓶装面板。标签产品数据存在不同营销结束日期；因此页面不描述任何一项为当前供应、在售或可获得。XANAX XR、其他包装、其他市场或其他阿普唑仑产品不能按名称、颜色、mg 或刻痕并入本档案。", "sourceDocuments": [ { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_ca630b8f06f82f9b", "label": "FDA：XANAX 2023 美国标签档案（NDA 018276）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018276s059lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 018276", "approvalTimeline": [ { "date": "1981", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1981。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1981. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_ca630b8f06f82f9b", "label": "FDA: XANAX label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018276s059lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2023", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2023 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2023 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_ca630b8f06f82f9b", "label": "FDA: XANAX label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018276s059lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/xanax/", "en": "https://origindrug.com/en/drugs/xanax/" }, "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." ] }