{ "id": "keflex", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "KEFLEX", "generic": "头孢氨苄", "aliases": [ "Keflex", "cephalexin", "cefalexin", "头孢氨苄胶囊", "头孢氨苄", "NDA 050405" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 FDA 当前 KEFLEX 口服胶囊处方信息（NDA 050405；SUPPL-111；2026-08 修订）", "dosageFormClass": "头孢氨苄口服胶囊：每粒 250 mg、500 mg 或 750 mg；本档案分别记录四个当前美国瓶装身份", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1971", "archiveSponsorText": "Pragma Pharmaceuticals, LLC（FDA 2026 当前标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "cephalexin oral suspension", "头孢氨苄干混悬剂", "cephalexin tablet", "头孢氨苄片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-keflex-cephalexin-250mg-100-capsule-bottle-ndc-5846301101", "marketCode": "US", "labelVersion": { "zh": "FDA 当前美国处方信息（2026-08 修订；SUPPL-111）", "en": "Current U.S. FDA prescribing information (revised Aug 2026; SUPPL-111)" }, "dosageForm": { "zh": "KEFLEX 头孢氨苄口服胶囊", "en": "KEFLEX cephalexin oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58463-011-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于头孢氨苄 250 mg；100 粒瓶装", "en": "Equivalent to cephalexin 250 mg per capsule; 100-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢氨苄（以头孢氨苄一水合物提供）", "en": "cephalexin (supplied as cephalexin monohydrate)" }, "value": 250, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色与深绿色", "en": "white and dark green" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "KEFLEX / 250 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-keflex-cephalexin-500mg-100-capsule-bottle-ndc-5846301201", "marketCode": "US", "labelVersion": { "zh": "FDA 当前美国处方信息（2026-08 修订；SUPPL-111）", "en": "Current U.S. FDA prescribing information (revised Aug 2026; SUPPL-111)" }, "dosageForm": { "zh": "KEFLEX 头孢氨苄口服胶囊", "en": "KEFLEX cephalexin oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58463-012-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于头孢氨苄 500 mg；100 粒瓶装", "en": "Equivalent to cephalexin 500 mg per capsule; 100-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢氨苄（以头孢氨苄一水合物提供）", "en": "cephalexin (supplied as cephalexin monohydrate)" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅绿色与深绿色", "en": "light green and dark green" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "KEFLEX / 500 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-keflex-cephalexin-750mg-50-capsule-bottle-ndc-5846301350", "marketCode": "US", "labelVersion": { "zh": "FDA 当前美国处方信息（2026-08 修订；SUPPL-111）", "en": "Current U.S. FDA prescribing information (revised Aug 2026; SUPPL-111)" }, "dosageForm": { "zh": "KEFLEX 头孢氨苄口服胶囊", "en": "KEFLEX cephalexin oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58463-013-50", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于头孢氨苄 750 mg；50 粒瓶装", "en": "Equivalent to cephalexin 750 mg per capsule; 50-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢氨苄（以头孢氨苄一水合物提供）", "en": "cephalexin (supplied as cephalexin monohydrate)" }, "value": 750, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 50, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 50, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "深绿色", "en": "dark green" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "KEFLEX / 750 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-keflex-cephalexin-750mg-20-capsule-bottle-ndc-5846301320", "marketCode": "US", "labelVersion": { "zh": "FDA 当前美国处方信息（2026-08 修订；SUPPL-111）", "en": "Current U.S. FDA prescribing information (revised Aug 2026; SUPPL-111)" }, "dosageForm": { "zh": "KEFLEX 头孢氨苄口服胶囊", "en": "KEFLEX cephalexin oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58463-013-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于头孢氨苄 750 mg；20 粒瓶装", "en": "Equivalent to cephalexin 750 mg per capsule; 20-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢氨苄（以头孢氨苄一水合物提供）", "en": "cephalexin (supplied as cephalexin monohydrate)" }, "value": 750, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 20, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 20, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "深绿色", "en": "dark green" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "KEFLEX / 750 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验当前标签中的颜色、刻字、强度、NDC 与包装数量，但没有把文字规格冒充为官方包装图片", "en": "Current label text verifies colour, imprint, strength, NDC and pack count, but text-only identity is not presented as an official package image" }, "summary": { "zh": "FDA 2026 当前标签提供 250 mg、500 mg、750 mg 胶囊的外观文字和四个瓶装 NDC，但本次没有取得与每个当前包装一一对应、可安全公开展示的官方主展示面。因此页面展示来源可追溯的文字身份和可放大说明书，不使用零售图、再包装图或历史图片代替当前 KEFLEX 包装。", "en": "The 2026 FDA label provides appearance text for 250, 500 and 750 mg capsules and four bottle NDCs, but this review did not obtain an official principal display panel safely matched one-to-one to each current pack. The page therefore shows source-traceable text identity and an enlarged label, without substituting retail, repackaged or historical imagery for a current KEFLEX pack." }, "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "KEFLEX 说明书放大阅读：先分清每粒 mg、胶囊与处方频次", "en": "KEFLEX label reading: separate mg per capsule, the capsule form and the prescribed schedule" }, "summary": { "zh": "FDA 2026 当前说明书分别列出 250、500、750 mg 口服胶囊。本模块帮助普通读者核对准确产品、过敏与严重腹泻警示、肾功能和相互作用问题；它不会给出个人粒数、间隔或疗程。", "en": "The current 2026 FDA label separately lists 250, 500 and 750 mg oral capsules. This module helps ordinary readers check the exact product, allergy and serious-diarrhoea warnings, kidney function and interaction questions; it gives no individual capsule count, interval or course." }, "checks": [ { "zh": "250、500、750 mg 是每粒胶囊所含头孢氨苄的标签标示量，不是一次吃几粒或一天吃几次。不能只看总毫克数自行用多粒小规格替代大规格、打开胶囊分一半、补服或拼接疗程。", "en": "250, 500 and 750 mg are the labelled cephalexin amounts per capsule, not capsules per dose or doses per day. Do not self-substitute several smaller capsules for a larger one, open and halve a capsule, make up a dose or assemble a course from a total milligram number." }, { "zh": "使用前需要把头孢菌素、青霉素或其他药物的既往过敏反应告诉开方团队。呼吸困难、面部或咽喉肿胀、广泛皮疹、晕厥或其他严重过敏表现需要立即使用当地急救服务。", "en": "Tell the prescriber about previous reactions to cephalosporins, penicillins or other medicines. Breathing difficulty, facial or throat swelling, widespread rash, fainting or another severe allergic feature requires immediate local emergency care." }, { "zh": "严重、持续或带血腹泻，明显腹痛、发热、脱水或虚弱可能需要尽快医疗评估；标签说明相关问题可能在抗菌药结束后出现。不要自行用止泻药掩盖严重症状。", "en": "Severe, persistent or bloody diarrhoea, marked abdominal pain, fever, dehydration or weakness may require prompt medical assessment; the label explains that this problem can appear after antibacterial treatment has ended. Do not self-use an antidiarrhoeal medicine to mask severe symptoms." }, { "zh": "老年人或肾功能受损者尤其需要让专业人员核对肾功能与处方；标签还列出与二甲双胍、丙磺舒以及部分尿糖检测有关的注意事项。网页不根据年龄、化验值或药名自动改变个人用法。", "en": "Older adults or people with impaired kidney function especially need professional review of kidney function and the prescription. The label also notes metformin, probenecid and some urine-glucose testing. The site does not change individual use from age, a laboratory value or a medicine name." } ], "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "头孢氨苄怎样起作用：抑制细菌细胞壁合成，不等于对所有感染都有效", "en": "How cephalexin works: inhibiting bacterial cell-wall synthesis does not mean it treats every infection" }, "summary": { "zh": "FDA 当前说明书说明头孢氨苄通过抑制细菌细胞壁合成发挥杀菌作用。机制只能帮助理解药物类别；不能仅凭发热、咳嗽、咽痛、尿路或皮肤症状决定是不是细菌感染、是否敏感、该不该使用或需要多长疗程。", "en": "The current FDA label explains that cephalexin is bactericidal through inhibition of bacterial cell-wall synthesis. The mechanism only helps explain the class; fever, cough, sore throat, urinary or skin symptoms alone cannot establish a bacterial cause, susceptibility, whether it should be used or for how long." }, "checks": [ { "zh": "抗菌药不治疗普通病毒性感冒。不要拿剩药、与家人共用、因症状相似就自行开始，或在感觉好转后自行缩短处方疗程。", "en": "Antibacterials do not treat an ordinary viral cold. Do not use leftovers, share, self-start because symptoms seem similar or shorten a prescribed course because you feel better." }, { "zh": "同属头孢菌素或都用于感染，不表示 KEFLEX 可以与阿莫西林、阿莫西林/克拉维酸、阿奇霉素、克林霉素或左氧氟沙星自行替换、轮换或叠加。", "en": "A cephalosporin class or infection-related use does not make KEFLEX self-switchable, alternatable or combinable with amoxicillin, amoxicillin/clavulanate, azithromycin, clindamycin or levofloxacin." }, { "zh": "准确病原、培养或药敏结果、感染部位、过敏史、肾功能、年龄和完整药单都可能影响专业判断；网页只帮助读懂说明书，不替个人选抗菌药。", "en": "The organism, culture or susceptibility result, infection site, allergy history, kidney function, age and complete medicine list can all affect professional judgement. The site helps read the label and does not select an antibacterial for an individual." } ], "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "KEFLEX", "generic": "头孢氨苄", "dosageFormClass": "头孢氨苄口服胶囊：每粒 250 mg、500 mg 或 750 mg；本档案分别记录四个当前美国瓶装身份" }, "labelSource": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "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": "2026-08-28", "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": "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": "2026-08-28", "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": "KEFLEX 是头孢氨苄口服胶囊品牌档案。FDA 2026 当前标签列有 250 mg、500 mg、750 mg 三种每粒强度和四个瓶装身份。本页把商品名、通用名、每粒 mg、NDC、外观文字、说明书和重要安全问题分开说明；不会从包装数字推算任何人的粒数、频率或疗程。", "history": "FDA 当前处方信息将 KEFLEX 的美国初始批准年份列为 1971，Drugs@FDA 当前申请页记录 NDA 050405 及 2026-08-03 的 SUPPL-111 标签。口服混悬剂、其他头孢氨苄剂型、其他厂牌或市场产品不并入这四个胶囊包装身份。", "sourceDocuments": [ { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_1755c454827a8b20", "label": "FDA Drugs@FDA：KEFLEX（cephalexin）NDA 050405 当前申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050405", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "FDA NDA 050405（KEFLEX / cephalexin oral capsules）", "approvalTimeline": [ { "date": "1971-01-01", "title": { "zh": "美国初始批准年份", "en": "Initial U.S. approval year" }, "detail": { "zh": "FDA 当前标签列出 Initial U.S. Approval: 1971。这里只记录年份，不推定具体首批包装、其他市场状态或当前供应。", "en": "The current FDA label states Initial U.S. Approval: 1971. This records the year only and does not infer the first pack, another market's status or current supply." }, "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2015-10-30", "title": { "zh": "FDA 批准 SUPPL-106 标签更新", "en": "FDA approved the SUPPL-106 label update" }, "detail": { "zh": "FDA 批准信将 KEFLEX 250、500、750 mg 胶囊与 NDA 050405 相连。该节点用于核对申请历史，不替代当前标签。", "en": "The FDA approval letter links KEFLEX 250, 500 and 750 mg capsules to NDA 050405. This node checks application history and does not replace the current label." }, "source": { "id": "src_5554ee784d5f74ac", "label": "FDA：KEFLEX NDA 050405/S-106 补充批准信（2015）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050405Orig1s106ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-08-03", "title": { "zh": "FDA 发布 SUPPL-111 当前标签", "en": "FDA posted the current SUPPL-111 label" }, "detail": { "zh": "Drugs@FDA 当前申请页列出 2026-08-03 的 SUPPL-111 标签，处方信息修订日期为 2026-08。日期定位文件版本，不是任何人的开始用药日、疗程或库存结论。", "en": "The current Drugs@FDA application page lists the SUPPL-111 label on 3 Aug 2026, with prescribing information revised Aug 2026. The date identifies the file version, not anyone's start date, course or a stock conclusion." }, "source": { "id": "src_1755c454827a8b20", "label": "FDA Drugs@FDA：KEFLEX（cephalexin）NDA 050405 当前申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050405", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 FDA 当前申请记录、当前口服胶囊说明书和四个准确文字包装身份", "en": "Current FDA application record, oral-capsule label and four exact text package identities linked" }, "detail": { "zh": "本页记录 250、500、750 mg 胶囊的 NDC、瓶装数量、颜色与刻字。标签存在不等于任何地点有库存、可购买、适合个人或可以自行换规格。", "en": "The dossier records NDC, bottle count, colour and imprint for 250, 500 and 750 mg capsules. A label does not establish local stock, purchase availability, individual suitability or self-switching between strengths." } }, { "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": "不从美国品牌、NDA、通用名或胶囊外观推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. brand, NDA, generic name or capsule appearance." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "包装写 500 mg，是否就表示一次吃一粒？", "en": "Does 500 mg on the pack mean one capsule per dose?" }, "answer": { "zh": "不是。500 mg 是每粒准确胶囊中的标签标示量；个人粒数、频率、疗程与是否适用必须来自准确处方，并结合感染类型、过敏史、肾功能、年龄和完整药单由专业人员确认。", "en": "No. 500 mg is the labelled amount in each exact capsule. Individual capsule count, frequency, course and suitability must come from the exact prescription and professional review of infection type, allergy history, kidney function, age and the complete medicine list." } }, { "question": { "zh": "胶囊太大，可以打开后倒一半或混进食物吗？", "en": "If the capsule is too large, can it be opened, halved or mixed into food?" }, "answer": { "zh": "不要自行这样做。当前页面核验的是完整口服胶囊，没有证据把目测分半或混食物写成等量、稳定和适合个人的替代方法。改变前请让药师或开方团队核对准确产品、可用剂型和处方。", "en": "Do not do this yourself. This page verifies an intact oral capsule and has no evidence that visual halving or mixing with food is an equal, stable and individually suitable alternative. Before changing it, ask a pharmacist or prescriber to check the exact product, available form and prescription." } } ], "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/keflex/", "en": "https://origindrug.com/en/drugs/keflex/" }, "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." ] }