{ "id": "namenda", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "NAMENDA", "generic": "盐酸美金刚", "aliases": [ "NAMENDA", "memantine", "memantine hydrochloride", "盐酸美金刚", "Lupin memantine", "ANDA 090051", "68180-229-07", "68180-230-07" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国：NAMENDA 历史原品牌标签列示 2025-10-31 营销结束；另展示 Lupin ANDA 090051 当前仿制药标签中的 5 mg、10 mg 两个准确 60 片瓶装。两个层级分开阅读，不由仿制药图反推原品牌外观、当前供应或可替代性。", "dosageFormClass": "口服薄膜衣片：历史 NAMENDA 5 mg／10 mg 两个 60 片瓶装文字身份；当前 Lupin 仿制药 5 mg／10 mg 两个 60 片瓶装与官方标签图，均按产品与 NDC 分开展示", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2003（历史美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Allergan, Inc.（NAMENDA 历史品牌标签）／Lupin Pharmaceuticals, Inc.（当前仿制药比较标签）／DailyMed（NLM）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NAMENDA XR", "memantine extended release", "memantine oral solution", "NAMZARIC" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-namenda-tablet-5mg-ndc-0456-3205-60", "marketCode": "US", "labelVersion": { "zh": "历史公开标签：页面 2018-11-01 更新；SPL v19 于 2024-12-20 发布", "en": "Historical public label: page updated 1 Nov 2018; SPL v19 published 20 Dec 2024" }, "dosageForm": { "zh": "口服薄膜衣片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0456-3205-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸美金刚 5 mg；60 片瓶装", "en": "Memantine hydrochloride 5 mg per tablet; 60-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸美金刚", "en": "memantine hydrochloride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕褐色", "en": "tan" }, "shape": { "zh": "胶囊形片", "en": "capsule-shaped tablet" }, "imprint": "5 / FL", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-namenda-tablet-10mg-ndc-0456-3210-60", "marketCode": "US", "labelVersion": { "zh": "历史公开标签：页面 2018-11-01 更新；SPL v19 于 2024-12-20 发布", "en": "Historical public label: page updated 1 Nov 2018; SPL v19 published 20 Dec 2024" }, "dosageForm": { "zh": "口服薄膜衣片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0456-3210-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸美金刚 10 mg；60 片瓶装", "en": "Memantine hydrochloride 10 mg per tablet; 60-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸美金刚", "en": "memantine hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "灰色", "en": "gray" }, "shape": { "zh": "胶囊形片", "en": "capsule-shaped tablet" }, "imprint": "10 / FL", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lupin-memantine-hydrochloride-5mg-60-tablet-bottle-ndc-6818022907", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 ANDA 仿制药标签（患者信息 2025-08 修订；SPL 2025-12-29）", "en": "Current U.S. DailyMed ANDA generic label (patient information revised Aug 2025; SPL 29 Dec 2025)" }, "dosageForm": { "zh": "盐酸美金刚薄膜衣口服片（仿制药比较项；非 NAMENDA 原品牌包装）", "en": "memantine hydrochloride film-coated oral tablet (generic comparator; not a NAMENDA originator-brand pack)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 68180-229-07", "pouchCode": null, "applicationNumber": "ANDA 090051", "presentationRole": "generic_comparator_not_originator_brand", "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸美金刚 5 mg；60 片瓶装", "en": "Memantine hydrochloride 5 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=392d48fd-7c93-40f3-9ab0-d0f304b7e439-11.jpg&setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸美金刚", "en": "memantine hydrochloride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、递增或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, titration or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "60 片处方药瓶装标签展示面", "en": "60-tablet prescription bottle label panel" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕褐色", "en": "tan" }, "shape": { "zh": "胶囊形、双凸薄膜衣片", "en": "capsule-shaped, biconvex film-coated tablet" }, "imprint": "LU / W01", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b5e03ac68dbf696a", "label": "DailyMed（NLM）：Lupin 盐酸美金刚片当前美国 ANDA 090051 仿制药标签与准确瓶装展示面", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lupin-memantine-hydrochloride-10mg-60-tablet-bottle-ndc-6818023007", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 ANDA 仿制药标签（患者信息 2025-08 修订；SPL 2025-12-29）", "en": "Current U.S. DailyMed ANDA generic label (patient information revised Aug 2025; SPL 29 Dec 2025)" }, "dosageForm": { "zh": "盐酸美金刚薄膜衣口服片（仿制药比较项；非 NAMENDA 原品牌包装）", "en": "memantine hydrochloride film-coated oral tablet (generic comparator; not a NAMENDA originator-brand pack)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 68180-230-07", "pouchCode": null, "applicationNumber": "ANDA 090051", "presentationRole": "generic_comparator_not_originator_brand", "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸美金刚 10 mg；60 片瓶装", "en": "Memantine hydrochloride 10 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=392d48fd-7c93-40f3-9ab0-d0f304b7e439-13.jpg&setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸美金刚", "en": "memantine hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、递增或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, titration or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "60 片处方药瓶装标签展示面", "en": "60-tablet prescription bottle label panel" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "灰色", "en": "gray" }, "shape": { "zh": "胶囊形、双凸薄膜衣片", "en": "capsule-shaped, biconvex film-coated tablet" }, "imprint": "LU / W02", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b5e03ac68dbf696a", "label": "DailyMed（NLM）：Lupin 盐酸美金刚片当前美国 ANDA 090051 仿制药标签与准确瓶装展示面", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "NAMENDA 历史原品牌图仍不展示；当前仿制药包装图另行标识", "en": "Historical NAMENDA originator-brand images remain withheld; current generic images are identified separately" }, "summary": { "zh": "NAMENDA 的历史 DailyMed 标签可追溯商品名、5 mg／10 mg、两个历史 NDC、60 片瓶装与美国营销结束日期，但未保留可用的一一对应原品牌公开图，因此不展示原品牌包装图，只保留文字身份。页面新增的两张图明确属于 Lupin ANDA 090051 当前仿制药 NDC 68180-229-07 与 68180-230-07，不得被理解为 NAMENDA 原品牌外观、真伪证明或换药依据。", "en": "The historical NAMENDA DailyMed label traces the trade name, 5 mg/10 mg, two historical NDCs, 60-tablet bottles and the U.S. marketing-end date, but no usable one-to-one public originator-brand image was retained, so originator-brand package images are not shown and those packs remain text-only. The two newly shown images explicitly belong to current Lupin ANDA 090051 generic NDC 68180-229-07 and 68180-230-07; they must not be read as NAMENDA originator-brand appearance, authentication or a switching basis." }, "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "NAMENDA／盐酸美金刚说明书放大阅读：先分历史原品牌与当前仿制药", "en": "NAMENDA / memantine label reading: separate the historical originator brand from a current generic first" }, "summary": { "zh": "本模块并列但不混合两类来源：NAMENDA 历史品牌标签，以及 Lupin 当前仿制药标签与电子说明书。5 mg、10 mg、NDC、60 片和外形只用于核对准确产品；页面不提供个人片数、递增、漏用补救、开始、停用、联用、换药或购买方案。", "en": "This module places two source layers side by side without merging them: the historical NAMENDA brand label and the current Lupin generic label with its electronic leaflet. The 5 mg, 10 mg, NDC, 60-tablet count and appearance identify an exact product only; the page provides no individual tablet count, titration, missed-use remedy, initiation, stopping, co-use, switching or purchase plan." }, "checks": [ { "zh": "先同时核对 NAMENDA、盐酸美金刚、5 mg 或 10 mg、NDC、口服薄膜衣片和目标市场。共有品牌或通用名，不证明另一强度、NAMENDA XR、口服溶液、复方产品或另一市场的产品可以互换。", "en": "Check NAMENDA, memantine hydrochloride, 5 mg or 10 mg, NDC, film-coated oral-tablet form and target market together. A shared brand or generic name does not prove that another strength, NAMENDA XR, an oral solution, a combination product or another-market product is interchangeable." }, { "zh": "5 mg、10 mg 和“60 片瓶装”是这两个历史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以掰开的说明。任何实际使用问题应带着现行药盒、处方和完整药单请药师或开方团队核对。", "en": "The 5 mg, 10 mg and “60-tablet bottle” wording identifies these two historical label panels; it does not say how many tablets to use, when to change, whether to make up a missed use or whether splitting is appropriate. Take the current pack, prescription and full medicine list to a pharmacist or prescribing team for any actual-use question." }, { "zh": "标签中的不良反应和相互作用段落用于提出问题，不用于网页判断某个不适是否由这款药造成。尤其在高龄、多病共存或多药并用时，不要因头晕、困惑、便秘、尿液酸碱相关提示或包装数字自行停用、叠加、轮换或调整。", "en": "Adverse-reaction and interaction sections of the label help frame questions; they do not let a webpage determine the cause of a symptom. Especially with older age, multiple conditions or multiple medicines, do not self-stop, combine, alternate or adjust because of dizziness, confusion, constipation, urine-pH-related wording or package numbers." }, { "zh": "当前仿制药瓶上的 Lupin、NDC 68180-229-07 或 68180-230-07、LU/W01 或 LU/W02 与官方图可帮助核对手中药瓶，但不能当作 NAMENDA 原品牌包装图。照护者应把药瓶、处方、全部其他药物与补充剂一起核对，尤其不要把普通片、缓释胶囊、口服液或 NAMZARIC 复方按毫克数自行拼接或替换。", "en": "Lupin, NDC 68180-229-07 or 68180-230-07, LU/W01 or LU/W02 and the official current generic label images can help check a bottle in hand, but they are not NAMENDA originator-brand pack images. A caregiver should review the bottle, prescription, all other medicines and supplements together, and must not assemble or substitute an immediate-release tablet, extended-release capsule, oral solution or NAMZARIC combination by comparing milligram numbers." } ], "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "盐酸美金刚怎样起作用：历史标签把它描述为 NMDA 受体拮抗剂", "en": "How memantine hydrochloride works: the historical label describes an NMDA-receptor antagonist" }, "summary": { "zh": "这份历史标签在临床药理部分将盐酸美金刚描述为 NMDA 受体拮抗剂。它解释的是标签用语中的一个药物作用路径，不预测任何个人的认知变化、适用性、疗程、片数或联用方案。", "en": "In Clinical Pharmacology, this historical label describes memantine hydrochloride as an NMDA-receptor antagonist. It explains one drug-action pathway in the label; it does not predict an individual's cognitive change, suitability, course, tablet count or co-use plan." }, "checks": [ { "zh": "NMDA 是一种受体名称；“拮抗剂”描述药物与该受体相关作用的方向。这个机制词不能单独说明某个人是否适合、何时见效、应持续多久或是否应更换产品。", "en": "NMDA is the name of a receptor, and “antagonist” describes the direction of a drug's related action. This mechanism term alone cannot tell whether a person is suitable, when an effect will occur, how long use should continue or whether a product should be changed." }, { "zh": "同为“认知”相关药物、标签中出现相近术语，或共同出现于一张药单，都不建立可以自行合并、轮换或替代的关系。应让专业人员按准确产品、目标市场现行标签、既往反应和完整药单复核。", "en": "Being described as cognition-related, having similar label terms or appearing on the same medicine list does not establish that products can be self-combined, alternated or substituted. A professional should review the exact products, current target-market labels, prior reactions and full medicine list." }, { "zh": "若照护者发现明显的急性变化、跌倒风险、意识改变或不确定怎样处理，应使用当地紧急与专业渠道；不要把机制说明或历史标签当作自行加减、停用或补用的规则。", "en": "If a caregiver notices a marked acute change, fall risk, altered consciousness or uncertainty about what to do, use local urgent and professional care pathways; do not use a mechanism explanation or historical label as a rule for self-adjusting, stopping or making up use." } ], "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Clinical Pharmacology；Allergan）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "NAMENDA", "generic": "盐酸美金刚", "dosageFormClass": "口服薄膜衣片：历史 NAMENDA 5 mg／10 mg 两个 60 片瓶装文字身份；当前 Lupin 仿制药 5 mg／10 mg 两个 60 片瓶装与官方标签图，均按产品与 NDC 分开展示" }, "labelSource": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_b5e03ac68dbf696a", "label": "DailyMed（NLM）：Lupin 盐酸美金刚片当前美国 ANDA 090051 仿制药标签与准确瓶装展示面", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "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": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "NAMENDA 是盐酸美金刚的历史美国品牌档案：5 mg、10 mg 和两个 60 片瓶装只用于追溯已结束营销的原品牌记录。页面同时把当前 Lupin 仿制药的 5 mg 与 10 mg、准确 NDC、60 片瓶装及官方包装图单独列为比较项，帮助照护者核对手中现行药瓶。品牌史、当前仿制药与个人用法是三个不同问题；网页不根据毫克数、颜色或同成分关系决定片数、递增、停用、联用、轮换或替换。", "history": "美国历史标签列示 NAMENDA Initial U.S. Approval: 2003、NDA 021487、2003-10-16 营销起始与 2025-10-31 营销结束。当前 Lupin ANDA 090051 标签列示 5 mg、10 mg 两个 60 片瓶装并提供患者信息和包装图。页面保留这条从历史原品牌到当前仿制药比较项的时间线，但不把监管等效关系直接转成个体换药决定。", "sourceDocuments": [ { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_b5e03ac68dbf696a", "label": "DailyMed（NLM）：Lupin 盐酸美金刚片当前美国 ANDA 090051 仿制药标签与准确瓶装展示面", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_e9d038c315c72fe7", "label": "DailyMed（NLM）：Lupin 盐酸美金刚片当前美国电子说明书 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae&type=pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "electronic_label_pdf", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NDA 021487", "approvalTimeline": [ { "date": "2003", "title": { "zh": "历史标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the historical label" }, "detail": { "zh": "这份 NAMENDA 历史公开标签列示 Initial U.S. Approval: 2003；它只定位该美国历史档案，不建立其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "This historical NAMENDA public label lists Initial U.S. Approval: 2003. It locates this U.S. historical archive only; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in another market." }, "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2003-10-16", "title": { "zh": "历史标签产品数据所列美国营销起始日期", "en": "U.S. marketing-start date listed in historical-label product data" }, "detail": { "zh": "历史标签产品数据列示 NAMENDA 片剂的美国营销起始日期为 2003-10-16。该日期是历史产品记录，不是现行可得性、库存、个人用药或其他市场状态的证明。", "en": "Historical-label product data list 16 Oct 2003 as the U.S. marketing-start date for NAMENDA tablets. This is a historical product record, not evidence of current availability, stock, individual use or another-market status." }, "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-10-31", "title": { "zh": "历史标签产品数据所列美国营销结束日期", "en": "U.S. marketing-end date listed in historical-label product data" }, "detail": { "zh": "该历史标签的产品数据列示美国营销结束日期为 2025-10-31；因此本页不将 NAMENDA 表述为当前可购、在售、可替代或仍在美国供应。任何现行产品问题须回到目标市场的现行监管资料和专业人员。", "en": "Product data in this historical label list 31 Oct 2025 as the U.S. marketing-end date. This page therefore does not describe NAMENDA as currently purchasable, marketed, interchangeable or still supplied in the United States. Questions about a current product require the current target-market regulatory record and a professional." }, "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-12-29", "title": { "zh": "Lupin 当前仿制药 SPL 列示两个准确 60 片瓶装", "en": "Current Lupin generic SPL lists two exact 60-tablet bottles" }, "detail": { "zh": "ANDA 090051 当前公开标签分别列示 5 mg／NDC 68180-229-07／LU-W01 与 10 mg／NDC 68180-230-07／LU-W02，并提供准确包装图和患者信息。它是现行仿制药比较项，不是 NAMENDA 原品牌包装或个体换药许可。", "en": "The current ANDA 090051 public label separately lists 5 mg / NDC 68180-229-07 / LU-W01 and 10 mg / NDC 68180-230-07 / LU-W02 with exact package images and patient information. It is a current generic comparator, not a NAMENDA originator-brand pack or permission for an individual switch." }, "source": { "id": "src_b5e03ac68dbf696a", "label": "DailyMed（NLM）：Lupin 盐酸美金刚片当前美国 ANDA 090051 仿制药标签与准确瓶装展示面", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "NAMENDA 原品牌标签列示 2025-10-31 营销结束；Lupin 仿制药标签为当前比较项", "en": "The NAMENDA originator-brand label lists a marketing end of 31 Oct 2025; the Lupin generic label is a current comparator" }, "detail": { "zh": "NAMENDA 5 mg、10 mg 两个历史 60 片瓶装只保留文字身份，其历史标签产品数据列示美国营销结束日期为 2025-10-31；Lupin ANDA 090051 的两个当前 60 片瓶装另以准确 NDC、刻字和官方图展示。页面不把仿制药图冒充原品牌外观，也不据此建立库存、购买、换用或供应结论。", "en": "Two historical NAMENDA 60-tablet bottles at 5 mg and 10 mg retain text identity only, and product data in that historical label list a U.S. marketing end date of 31 Oct 2025. Two current Lupin ANDA 090051 60-tablet bottles are shown separately with exact NDCs, imprints and official images. The generic images are not presented as originator-brand appearance and do not establish stock, purchase, switching or supply." } }, { "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": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从这份美国历史标签推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场都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 this U.S. historical label; each market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "NAMENDA 5 mg、10 mg 或 60 片瓶装，是否意味着可以自行调整片数、换到 NAMENDA XR 或和其他认知相关药轮换？", "en": "Do NAMENDA 5 mg, 10 mg or a 60-tablet bottle mean that tablet count can be self-adjusted, or that a person can switch to NAMENDA XR or alternate with another cognition-related medicine?" }, "answer": { "zh": "不能。这些文字只识别历史标签中的准确片剂和瓶装。共同品牌、通用名、领域或相近毫克数均不建立自行调整、掰开、补用、合并、轮换或替换关系；请带现行药盒、处方与完整药单请药师或开方团队复核。", "en": "No. These words only identify exact tablets and bottles in a historical label. A shared brand, generic name, therapeutic area or similar milligram number does not establish self-adjustment, splitting, make-up use, combining, alternating or substitution; take the current pack, prescription and complete medicine list to a pharmacist or prescribing team." } }, { "question": { "zh": "页面上的 Lupin 药瓶图是不是 NAMENDA 原研药包装？", "en": "Are the Lupin bottle images on this page NAMENDA originator-brand packages?" }, "answer": { "zh": "不是。它们是一份当前美国仿制药标签中与 NDC 68180-229-07、68180-230-07 一一对应的准确展示面，仅用于帮助核对现行仿制药瓶；NAMENDA 原品牌历史包装因没有保留可用的一一对应公开图，仍只展示文字身份。", "en": "No. They are exact panels tied to NDC 68180-229-07 and 68180-230-07 in a current U.S. generic label and only help check those generic bottles. The historical NAMENDA originator-brand packages remain text-only because no usable one-to-one public image was retained." } } ], "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/namenda/", "en": "https://origindrug.com/en/drugs/namenda/" }, "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." ] }