{ "id": "trexall", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-27", "status": "published_traceable_archive" }, "names": { "brand": "TREXALL", "generic": "甲氨蝶呤", "aliases": [ "Trexall", "methotrexate", "methotrexate sodium", "甲氨蝶呤", "甲氨蝶呤片", "51285-366-01", "51285-367-01", "51285-368-01", "51285-369-01", "927/5", "928/7½", "929/10", "945/15" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国：DailyMed 当前 TREXALL 甲氨蝶呤薄膜衣口服片标签（SPL v14，2026-06-17 生效；ANDA 040385）。本页不从该美国文件推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格、包装或可替代性。", "dosageFormClass": "TREXALL 甲氨蝶呤薄膜衣口服片：5 mg、7.5 mg、10 mg、15 mg 每片；美国公开标签所列均为 30 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服（高风险准确产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "1999-10-29（FDA ANDA 040385 批准资料所列；不是 NDA 原研认定）", "archiveSponsorText": "Teva Women's Health LLC（DailyMed 当前美国公开标签所列包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "methotrexate injection", "甲氨蝶呤注射剂", "OTREXUP", "RASUVO", "REDI TREX", "another methotrexate tablet", "其他甲氨蝶呤片", "another market package", "其他市场包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-trexall-methotrexate-tablet-5mg-30-bottle-ndc-51285-366-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-17 生效；2026-06-29 发布）", "en": "Current U.S. DailyMed public label (effective 17 Jun 2026; published 29 Jun 2026)" }, "dosageForm": { "zh": "TREXALL 甲氨蝶呤薄膜衣口服片", "en": "TREXALL methotrexate film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 51285-366-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲氨蝶呤 5 mg；30 片瓶装", "en": "Methotrexate 5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c&name=image-2.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲氨蝶呤", "en": "methotrexate" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or missed-use instruction" } } ], "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": "2026-08-27", "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": "绿色", "en": "green" }, "shape": { "zh": "椭圆形、双凸、带刻痕薄膜衣片", "en": "oval, biconvex, scored film-coated tablet" }, "imprint": "stylized b / 927/5", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤 5 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trexall-methotrexate-tablet-7-5mg-30-bottle-ndc-51285-367-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-17 生效；2026-06-29 发布）", "en": "Current U.S. DailyMed public label (effective 17 Jun 2026; published 29 Jun 2026)" }, "dosageForm": { "zh": "TREXALL 甲氨蝶呤薄膜衣口服片", "en": "TREXALL methotrexate film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 51285-367-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲氨蝶呤 7.5 mg；30 片瓶装", "en": "Methotrexate 7.5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c&name=image-3.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲氨蝶呤", "en": "methotrexate" }, "value": 7.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or missed-use instruction" } } ], "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": "2026-08-27", "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": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆形、双凸、带刻痕薄膜衣片", "en": "oval, biconvex, scored film-coated tablet" }, "imprint": "stylized b / 928/7½", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤 7.5 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trexall-methotrexate-tablet-10mg-30-bottle-ndc-51285-368-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-17 生效；2026-06-29 发布）", "en": "Current U.S. DailyMed public label (effective 17 Jun 2026; published 29 Jun 2026)" }, "dosageForm": { "zh": "TREXALL 甲氨蝶呤薄膜衣口服片", "en": "TREXALL methotrexate film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 51285-368-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲氨蝶呤 10 mg；30 片瓶装", "en": "Methotrexate 10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c&name=image-4.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲氨蝶呤", "en": "methotrexate" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or missed-use instruction" } } ], "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": "2026-08-27", "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": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形、双凸、带刻痕薄膜衣片", "en": "oval, biconvex, scored film-coated tablet" }, "imprint": "stylized b / 929/10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤 10 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trexall-methotrexate-tablet-15mg-30-bottle-ndc-51285-369-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-17 生效；2026-06-29 发布）", "en": "Current U.S. DailyMed public label (effective 17 Jun 2026; published 29 Jun 2026)" }, "dosageForm": { "zh": "TREXALL 甲氨蝶呤薄膜衣口服片", "en": "TREXALL methotrexate film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 51285-369-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲氨蝶呤 15 mg；30 片瓶装", "en": "Methotrexate 15 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c&name=image-5.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲氨蝶呤", "en": "methotrexate" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or missed-use instruction" } } ], "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": "2026-08-27", "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": "紫色", "en": "purple" }, "shape": { "zh": "椭圆形、双凸、带刻痕薄膜衣片", "en": "oval, biconvex, scored film-coated tablet" }, "imprint": "stylized b / 945/15", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤 15 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-trexall-methotrexate-tablet-5mg-30-bottle-ndc-51285-366-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c&name=image-2.jpg", "alt": "TREXALL 甲氨蝶呤 5 mg、NDC 51285-366-01、30 片瓶装的美国 DailyMed 当前标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v14（2026-06-17 生效；2026-06-29 发布）", "presentation": "TREXALL 甲氨蝶呤 5 mg、NDC 51285-366-01、30 片瓶装标签展示面。", "notice": "此图只对应所引美国 DailyMed 标签中的 TREXALL 5 mg、NDC 51285-366-01、30 片瓶装。它只帮助核对准确标签身份与来源；不用于鉴定真伪，不代表 7.5 mg、10 mg、15 mg、其他甲氨蝶呤产品、其他市场包装、当前可得性、原研身份、可替代性或任何人的用药方案。", "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤 5 mg、NDC 51285-366-01、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TREXALL 说明书放大阅读：先核对准确强度，再核对处方上的具体星期", "en": "TREXALL label reading: check the exact strength, then the specific day written on the prescription" }, "summary": { "zh": "这是一页高风险安全阅读。美国当前标签将 TREXALL 列为甲氨蝶呤口服片，并突出“用药错误风险”：对按每周一次开具的方案，误按每天服用已导致死亡。网页不计算个人频率；它只提醒把药盒、强度、处方和具体星期交给药师或开方团队逐项核对。", "en": "This is a higher-risk safety reading. The current U.S. label identifies TREXALL as an oral methotrexate tablet and highlights medication-error risk: where a once-weekly regimen was prescribed, mistaken daily use has led to fatal adverse reactions. The site does not calculate an individual's frequency; it prompts an item-by-item check of the pack, strength, prescription and named day with a pharmacist or prescriber." }, "checks": [ { "zh": "先同时核对 TREXALL、甲氨蝶呤、薄膜衣口服片、每片强度、NDC、30 片瓶装和目标市场。5、7.5、10、15 mg 是不同片剂的每片标示量；不是网页可以相加、换算、拆分或推导个人片数的数字。", "en": "Check TREXALL, methotrexate, film-coated oral-tablet form, strength per tablet, NDC, 30-tablet bottle and target market together. 5, 7.5, 10 and 15 mg identify different strengths per tablet; they are not numbers the site can add, convert, split or use to derive an individual's tablet count." }, { "zh": "标签警示必须与实际处方上的频率一起读。若处方写每周一次，应把具体星期写清并由专业人员确认；不要把“每周一次”误读成“每天一次”。若已经多服、连续多天服用或不确定，不要等待网页答复，应立即联系当地急救、毒物咨询或负责治疗团队。", "en": "The label warning must be read with the frequency on the actual prescription. If the prescription says once weekly, the specific day should be made explicit and confirmed by a professional; do not read once weekly as once daily. If extra doses were taken, use occurred on consecutive days, or there is uncertainty, do not wait for a web response—contact local emergency, poison-information or treating services immediately." }, { "zh": "标签列出的肿瘤、类风湿关节炎、幼年特发性关节炎和严重银屑病是美国标签用途范围，不表示看到相同疾病名称就适合使用，也不能据此决定频率、疗程或停用。", "en": "Cancer, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and severe psoriasis are indications in the U.S. label. Seeing a matching condition name does not establish suitability and cannot determine frequency, duration or stopping." }, { "zh": "甲氨蝶呤标签还涉及妊娠、严重过敏、骨髓、胃肠道、肝、肺、皮肤、肾脏及药物相互作用等重要风险。请让药师或开方团队结合实际处方、检验资料和完整药单核对；网页不会据此给出继续、暂停、补服或替代指令。", "en": "The methotrexate label also addresses pregnancy, severe hypersensitivity, bone-marrow, gastrointestinal, liver, lung, skin and kidney toxicity and drug interactions. Have a pharmacist or prescriber review the actual prescription, relevant tests and complete medicine list; the site does not turn these points into continuation, pausing, make-up use or substitution instructions." } ], "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤当前美国公开标签（盒装警示、5.9 用药错误风险与患者信息）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "甲氨蝶呤怎样起作用：抑制二氢叶酸还原酶（机制说明，不是个人频率）", "en": "How methotrexate works: inhibition of dihydrofolate reductase (a mechanism, not an individual schedule)" }, "summary": { "zh": "美国当前标签说明，甲氨蝶呤抑制二氢叶酸还原酶，进而干扰嘌呤核苷酸和胸苷酸相关过程以及 DNA 合成、修复和细胞复制；同一标签也明确写明其在类风湿关节炎和银屑病中的作用机制尚不清楚。机制不能用来推导任何人的片数、星期、疗程、监测、联用或替代。", "en": "The current U.S. label says methotrexate inhibits dihydrofolate reductase, thereby interfering with pathways involving purine nucleotides and thymidylate and with DNA synthesis, repair and cellular replication; the same label states that its mechanism in rheumatoid arthritis and psoriasis is unknown. A mechanism cannot determine anyone's tablet count, day, duration, monitoring, co-use or substitution." }, "checks": [ { "zh": "“抑制二氢叶酸还原酶”解释的是作用路径，不表示可以从叶酸、症状、疾病名称或一次检验结果自行决定加减、漏服处理、停用或恢复。", "en": "“Inhibits dihydrofolate reductase” describes a pathway; it does not allow folate use, symptoms, a condition name or one test result to determine an increase, decrease, missed-use action, stop or restart." }, { "zh": "标签指出增殖活跃的组织可能更敏感，这有助于理解为什么需要严密监测；它不能由网页转化成个人风险预测，也不能解释某个具体症状的原因。", "en": "The label notes that actively proliferating tissues may be more sensitive. This helps explain why close monitoring matters, but it cannot be converted by a website into an individual risk prediction or an explanation for a specific symptom." }, { "zh": "不同甲氨蝶呤产品可能有不同剂型、浓度、装置、市场标签和频率。共同成分或相同毫克数不建立自动互换；应把准确药盒、处方和完整药单交给专业人员核对。", "en": "Methotrexate products can differ in dosage form, concentration, device, market label and schedule. A shared ingredient or matching milligram number does not establish automatic interchangeability; have a professional review the exact pack, prescription and complete medicine list." } ], "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 当前美国公开标签（12.1 Mechanism of Action）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "TREXALL", "generic": "甲氨蝶呤", "dosageFormClass": "TREXALL 甲氨蝶呤薄膜衣口服片：5 mg、7.5 mg、10 mg、15 mg 每片；美国公开标签所列均为 30 片瓶装" }, "labelSource": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤当前美国公开标签（Teva Women's Health；SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "productRoutes": [ { "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤当前美国公开标签（Teva Women's Health；SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "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": "2026-08-27", "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_dacb1405745102d9", "label": "FDA：Methotrexate Sodium Tablets / TREXALL ANDA 040385 批准资料（1999-10-29）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040385_S000_TREXALL%20TABLETS%20_ORIGINAL.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "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": "2026-08-27", "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": "2026-08-27", "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": "TREXALL 是美国当前公开标签中的甲氨蝶呤薄膜衣口服片，列有 5 mg、7.5 mg、10 mg、15 mg 四种每片强度和四个 30 片瓶装 NDC。它是高风险用药档案：标签警示，对按每周一次开具的方案，误把每周用量按每天服用已导致致命不良反应。网页不提供任何人的片数、日期、漏服、加减、停用或替代方案；若已经多服、误按每天服用或不确定，应立即联系当地急救、毒物咨询或负责治疗团队，并带上药盒与处方。", "history": "FDA 批准资料记录 Methotrexate Sodium Tablets / TREXALL 对应 ANDA 040385，批准日期为 1999-10-29；DailyMed 当前标签另列活性成分的 Initial U.S. Approval 为 1953。两者不是同一含义：前者定位该申请与品牌记录，后者是标签中的活性成分历史字段。页面不会把 1953、品牌名或包装图转换成 TREXALL 的原研认定。", "sourceDocuments": [ { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤当前美国公开标签（Teva Women's Health；SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, { "id": "src_dacb1405745102d9", "label": "FDA：Methotrexate Sodium Tablets / TREXALL ANDA 040385 批准资料（1999-10-29）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040385_S000_TREXALL%20TABLETS%20_ORIGINAL.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" } ], "applicationNumber": "ANDA 040385（DailyMed 当前标签与 FDA 批准资料所列；不作为原研认定）", "approvalTimeline": [ { "date": "1999-10-29", "title": { "zh": "FDA ANDA 040385 批准资料", "en": "FDA ANDA 040385 approval record" }, "detail": { "zh": "FDA 公开批准资料将 Methotrexate Sodium Tablets / TREXALL 与 ANDA 040385、1999-10-29 批准日期相连。ANDA 是简略新药申请；本页因此不把该记录写成 NDA 原研批准，也不由品牌名推定原研身份。", "en": "The public FDA approval record links Methotrexate Sodium Tablets / TREXALL to ANDA 040385 and the approval date 29 Oct 1999. ANDA is an Abbreviated New Drug Application; this page therefore does not describe the record as an NDA originator approval or infer originator status from the brand name." }, "source": { "id": "src_dacb1405745102d9", "label": "FDA：Methotrexate Sodium Tablets / TREXALL ANDA 040385 批准资料（1999-10-29）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040385_S000_TREXALL%20TABLETS%20_ORIGINAL.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" } }, { "date": "2026-06-17", "title": { "zh": "DailyMed SPL v14 生效：用药错误风险警示更新", "en": "DailyMed SPL v14 effective: medication-error warning updated" }, "detail": { "zh": "当前公开标签列出四种强度、四个 30 片瓶装 NDC，并在盒装警示及 5.9 节强调：对按每周一次开具的方案，误按每天服用甲氨蝶呤片已导致死亡。该日期定位文件版本，不是任何人的用药频率。", "en": "The current public label lists four strengths and four 30-tablet bottle NDCs and emphasises in the boxed warning and section 5.9 that, where once-weekly use was prescribed, mistaken daily administration of methotrexate tablets has resulted in death. This date identifies a document version, not anyone's schedule." }, "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤当前美国公开标签（SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前 ANDA 品牌标签、四种准确强度与四个包装面板", "en": "Current ANDA brand label, four exact strengths and four package panels linked" }, "detail": { "zh": "本页分别记录 TREXALL 5 mg、7.5 mg、10 mg、15 mg 薄膜衣口服片的 NDC 与 30 片瓶装面板，并明示 ANDA 040385。它用于产品身份和安全阅读，不用于鉴定真伪，也不建立当前供应、库存、购买、个人片数、频率、停用、换药或原研身份。", "en": "This page separately records the NDC and 30-tablet bottle panel for TREXALL 5 mg, 7.5 mg, 10 mg and 15 mg film-coated oral tablets and explicitly identifies ANDA 040385. It supports product identity and safety reading; it does not authenticate a product or establish current supply, stock, purchase, individual tablet count, frequency, stopping, switching or originator status." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, the EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国 ANDA、DailyMed 名称、NDC、标签警示、每片强度或包装图推定当地商品名、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. ANDA, DailyMed name, NDC, label warning, strength per tablet or package image; each market requires separate review against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "看到 TREXALL 包装上的 5、7.5、10 或 15 mg，能否算出我该吃几片、哪一天吃？", "en": "Can the 5, 7.5, 10 or 15 mg on a TREXALL pack tell me how many tablets to take or on which day?" }, "answer": { "zh": "不能。这些数字只识别每片标示强度。频率、具体星期和片数必须来自实际处方并由开方团队或药师确认。若已经多服、把每周一次误作每天一次、连续多天服用或不确定，应立即联系当地急救、毒物咨询或负责治疗团队，不要等待网页答复。", "en": "No. These numbers identify labelled strength per tablet only. Frequency, named day and tablet count must come from the actual prescription and be confirmed by the prescriber or pharmacist. If extra doses were taken, once-weekly use was mistaken for daily use, use occurred on consecutive days, or there is uncertainty, contact local emergency, poison-information or treating services immediately rather than waiting for a web response." } }, { "question": { "zh": "TREXALL 是原研药吗？", "en": "Is TREXALL an originator medicine?" }, "answer": { "zh": "本页不把它标为美国原研药。当前 DailyMed 标签明确列出 ANDA040385，FDA 批准资料也对应 ANDA 040385；这是该美国品牌甲氨蝶呤片的可追溯申请与标签身份。原研/仿制关系必须按目标市场、准确产品和监管申请逐项核对，不能只看品牌名。", "en": "This page does not label it as a U.S. originator medicine. The current DailyMed label explicitly lists ANDA040385, and the FDA approval record also corresponds to ANDA 040385; this is the traceable application and label identity for the U.S. branded methotrexate tablet. Originator/generic relationships require exact product-, market- and application-level review and cannot be inferred from a brand name alone." } } ], "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/trexall/", "en": "https://origindrug.com/en/drugs/trexall/" }, "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." ] }