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not an instruction to add another statin or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_lists_marketing_end_date", "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、无刻痕薄膜衣片，约 11 mm；无刻痕不表示可自行掰开或磨碎", "en": "oval, unscored film-coated tablet, approximately 11 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "CDT;102", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 10/20 mg、NDC 58151-061-93、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-caduet-amlodipine-10mg-atorvastatin-40mg-30-bottle-ndc-5815106293", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-25 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 25 Jun 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CADUET 氨氯地平/阿托伐他汀薄膜衣口服片", "en": "CADUET amlodipine/atorvastatin film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-062-93", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 10 mg＋阿托伐他汀 40 mg；30 片瓶装", "en": "Amlodipine 10 mg plus atorvastatin 40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=caduet-16.jpg&setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数、加量或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count, increase or conversion instruction" } }, { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加一盒他汀或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another statin or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "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、无刻痕薄膜衣片，约 14 mm；无刻痕不表示可自行掰开或磨碎", "en": "oval, unscored film-coated tablet, approximately 14 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "CDT;104", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 10/40 mg、NDC 58151-062-93、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-caduet-amlodipine-10mg-atorvastatin-80mg-30-bottle-ndc-5815106393", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-25 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 25 Jun 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CADUET 氨氯地平/阿托伐他汀薄膜衣口服片", "en": "CADUET amlodipine/atorvastatin film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-063-93", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 10 mg＋阿托伐他汀 80 mg；30 片瓶装", "en": "Amlodipine 10 mg plus atorvastatin 80 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=caduet-17.jpg&setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数、加量或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count, increase or conversion instruction" } }, { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加一盒他汀或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another statin or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "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、无刻痕薄膜衣片，约 17 mm；无刻痕不表示可自行掰开或磨碎", "en": "oval, unscored film-coated tablet, approximately 17 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "CDT;108", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 10/80 mg、NDC 58151-063-93、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-caduet-amlodipine-5mg-atorvastatin-10mg-30-bottle-ndc-5815106493", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=caduet-10.jpg&setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "alt": { "zh": "DailyMed 当前 CADUET 5/10 mg、NDC 58151-064-93、30 片瓶装标签面板", "en": "Current DailyMed CADUET 5/10 mg, NDC 58151-064-93, 30-tablet bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（2026-06-25 更新）", "presentation": "CADUET 氨氯地平 5 mg/阿托伐他汀 10 mg 每片，NDC 58151-064-93，30 片瓶装。", "notice": "此图只对应 CADUET 5/10 mg、NDC 58151-064-93、30 片瓶装面板；不能代表另七个标签包装、三个仅在 Orange Book/历史批准记录中列出的 2.5 mg 组合、其他市场或仿制药，不用于鉴定真伪，也不证明实时库存或可替代性。", "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 5/10 mg、NDC 58151-064-93、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CADUET 说明书放大阅读：一片已有降压药和他汀，先查两条成分是否重复", "en": "CADUET label reading: one tablet already contains a blood-pressure medicine and a statin; check both ingredients for duplication" }, "summary": { "zh": "CADUET 的双数字表示同一片内两种成分。例如 5/40 mg 是氨氯地平 5 mg 加阿托伐他汀 40 mg，不是两片、半片或可以与单方药直接相加的换算式。标签要求两种成分分别评估；网页不会据血压或血脂替个人选择组合。", "en": "The paired numbers identify two ingredients in one CADUET tablet. For example, 5/40 mg means amlodipine 5 mg plus atorvastatin 40 mg; it is not two tablets, half a tablet or a conversion formula for adding single-ingredient products. The label requires each component to be assessed independently; the site does not choose a combination from an individual's blood pressure or lipid result." }, "checks": [ { "zh": "先逐盒核对成分。NORVASC 是单方氨氯地平，LIPITOR 是单方阿托伐他汀；LOTREL、AZOR、EXFORGE、EXFORGE HCT 与 TRIBENZOR 也可能共享氨氯地平。疑似重复可能是误用，也可能是专业人员有意安排，网页无法只凭名称判断；不要自行加上或停掉任何一盒。", "en": "Check active ingredients on every pack. NORVASC is amlodipine alone and LIPITOR is atorvastatin alone; LOTREL, AZOR, EXFORGE, EXFORGE HCT and TRIBENZOR may also share amlodipine. Suspected duplication may be accidental or intentionally prescribed, and the site cannot decide from names alone. Do not add or stop a pack yourself." }, { "zh": "年龄 ≥65 岁、甲状腺功能未控制、肾功能受损、使用某些相互作用药物或较高规格，会增加标签所述肌病和横纹肌溶解风险。出现无法解释的肌痛、压痛或无力，尤其伴发热、全身不适或深色尿，应尽快联系医疗团队；症状严重、迅速加重、意识异常或尿量显著减少时使用当地急救服务。", "en": "Age 65 years or older, uncontrolled hypothyroidism, renal impairment, certain interacting medicines and higher strengths increase the labelled risk of myopathy and rhabdomyolysis. Promptly contact the care team for unexplained muscle pain, tenderness or weakness, especially with fever, malaise or dark urine; use local emergency services for severe or rapidly worsening symptoms, altered consciousness or markedly reduced urine." }, { "zh": "标签列出葡萄柚汁、部分抗病毒药、克拉霉素、伊曲康唑、利福平和地高辛等相互作用边界。不要依据网页自行安排停药、错开时间或改变规格；让药师按准确产品、食物/饮品、补充剂和完整药单核对。", "en": "The label identifies interaction boundaries involving grapefruit juice, some antivirals, clarithromycin, itraconazole, rifampin and digoxin. Do not use the site to stop a medicine, schedule separation or change a strength; have a pharmacist review the exact products, foods or drinks, supplements and complete medicine list." }, { "zh": "严重肝损伤症状、黄疸或明显深色尿需要及时医疗评估。急性肝衰竭或失代偿性肝硬化属于标签禁忌边界；网页不读取化验值来决定继续、暂停或改量。", "en": "Symptoms of serious liver injury, jaundice or markedly dark urine need timely medical assessment. Acute liver failure or decompensated cirrhosis is a labelled contraindication boundary; the site does not read laboratory values to decide continuation, interruption or adjustment." }, { "zh": "开始使用或增加氨氯地平成分时，胸痛可能加重或发生心肌梗死。持续或加重的胸痛、呼吸困难、冷汗、晕厥或突发神经症状应使用当地急救服务，而不是等待网页判断。", "en": "Chest pain may worsen or myocardial infarction may occur when the amlodipine component is started or increased. Use local emergency services for persistent or worsening chest pain, breathing difficulty, cold sweats, fainting or sudden neurological symptoms rather than waiting for a website decision." }, { "zh": "怀孕可能造成胎儿伤害，使用期间不建议哺乳。已经怀孕、可能怀孕、计划怀孕或正在哺乳者应及时联系开方团队核对，不自行停换药。", "en": "Pregnancy may cause fetal harm and breastfeeding is not recommended during treatment. Anyone who is pregnant, may be pregnant, plans pregnancy or is breastfeeding should contact the prescribing team promptly and should not arrange stopping or switching independently." }, { "zh": "八种当前标签片剂均为椭圆形、无刻痕；白色对应氨氯地平 5 mg，蓝色对应 10 mg，但颜色只能作为同一现行标签内的辅助线索。不要仅凭颜色、印字或双数字鉴定真伪、掰片或换药。", "en": "All eight current-label tablets are oval and unscored. White corresponds to amlodipine 5 mg and blue to 10 mg, but colour is only an auxiliary clue within this exact current label. Do not authenticate, split or switch a medicine from colour, imprint or paired numbers alone." } ], "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 氨氯地平/阿托伐他汀当前美国公开标签（2026-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样分工：氨氯地平帮助血管舒张，阿托伐他汀抑制 HMG-CoA 还原酶", "en": "How the two ingredients differ: amlodipine supports arterial relaxation while atorvastatin inhibits HMG-CoA reductase" }, "summary": { "zh": "当前标签把氨氯地平描述为二氢吡啶类钙通道阻滞剂，把阿托伐他汀描述为 HMG-CoA 还原酶选择性、竞争性抑制剂。一片覆盖两条不同路径，不代表网页能用一个血压数或 LDL-C 数字替个人拆分、重组或转换方案。", "en": "The current label describes amlodipine as a dihydropyridine calcium-channel blocker and atorvastatin as a selective, competitive HMG-CoA reductase inhibitor. Two pathways in one tablet do not let the site split, rebuild or convert an individual's regimen from one blood-pressure or LDL-C value." }, "checks": [ { "zh": "氨氯地平成分常见剂量相关水肿，也可能与头晕或低血压有关；阿托伐他汀成分需要关注肌肉、肝脏、相互作用和血糖相关警示。只看到“心血管药”或商品名不足以完成安全核对。", "en": "Amlodipine commonly causes dose-related oedema and may relate to dizziness or hypotension. Atorvastatin requires attention to muscle, liver, interaction and glucose warnings. The words 'cardiovascular medicine' or the brand name alone are not a complete safety review." }, { "zh": "当前 DailyMed 标签列八种 5 或 10 mg 氨氯地平组合；Orange Book 另列三个 2.5 mg 组合。网页保留这一区别，不把监管规格表变成当前包装、个人起始规格或采购清单。", "en": "The current DailyMed label lists eight combinations with amlodipine 5 or 10 mg, while the Orange Book additionally lists three 2.5 mg combinations. The site preserves this distinction and does not turn a regulatory strengths table into current packs, an individual starting strength or a purchasing list." }, { "zh": "同一片里的两条作用路径不能分开停用、分开补服或按单方毫克数拼接。任何改动都要回到准确处方、实际药盒、症状、化验和完整药单，由开方团队或药师判断。", "en": "The two pathways in one tablet cannot be stopped separately, made up separately or reconstructed from single-ingredient milligram numbers. Any change must return to the exact prescription, actual pack, symptoms, laboratory results and complete medicine list for review by the prescribing team or pharmacist." } ], "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 氨氯地平/阿托伐他汀当前美国公开标签（2026-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CADUET", "generic": "氨氯地平/阿托伐他汀片", "dosageFormClass": "氨氯地平/阿托伐他汀固定两成分薄膜衣口服片：当前标签八个 5 或 10 mg／10、20、40 或 80 mg 组合；每组两个数字属于同一片内两种成分" }, "labelSource": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 氨氯地平/阿托伐他汀当前美国公开标签（2026-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 氨氯地平/阿托伐他汀当前美国公开标签（2026-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：CADUET，NDA 021540，11 个口服片规格列为处方 RLD；10/80 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：CADUET NDA 021540 申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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": "2026-08-29", "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": "CADUET 一片同时含氨氯地平和阿托伐他汀：前一个数字是氨氯地平，后一个数字是阿托伐他汀。它既不是单方 NORVASC，也不是单方 LIPITOR。若药单还出现这些单方药，或 LOTREL、AZOR、EXFORGE、EXFORGE HCT、TRIBENZOR 等共享氨氯地平的复方，应带所有药盒、处方和完整药单让药师或开方团队逐项核对，不要自行叠加、停药、轮换、掰片或按毫克换算。", "history": "FDA 于 2004-01-30 批准 CADUET NDA 021540 的八个 5/10 至 10/80 mg 组合，同年 2004-07-29 的 S-003 批准函增列 2.5/10、2.5/20 和 2.5/40 mg。当前 Orange Book 数据仍列 11 个处方 RLD 规格并把 10/80 mg 列为 RS；当前 DailyMed 标签页面则列八个 5 或 10 mg 氨氯地平组合包装。两类官方记录用途不同，不能据此推断每个规格实时供应。", "sourceDocuments": [ { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 氨氯地平/阿托伐他汀当前美国公开标签（2026-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：CADUET，NDA 021540，11 个口服片规格列为处方 RLD；10/80 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：CADUET NDA 021540 申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f3bb45ec1fe785d0", "label": "FDA：CADUET NDA 021540 原始批准函（2004-01-30）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21540ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_34a1d55a2d52039e", "label": "FDA：CADUET NDA 021540/S-003 增列 2.5 mg 氨氯地平组合规格批准函（2004-07-29）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21540s003ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 021540（CADUET / amlodipine and atorvastatin oral tablets）", "approvalTimeline": [ { "date": "2004-01-30", "title": { "zh": "CADUET 原始批准", "en": "Original CADUET approval" }, "detail": { "zh": "FDA 原始批准函列出八个 5/10 至 10/80 mg 固定复方规格。", "en": "The FDA original approval letter lists eight fixed-combination strengths from 5/10 through 10/80 mg." }, "source": { "id": "src_f3bb45ec1fe785d0", "label": "FDA：CADUET NDA 021540 原始批准函（2004-01-30）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21540ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2004-07-29", "title": { "zh": "增列三种 2.5 mg 氨氯地平组合", "en": "Three 2.5 mg amlodipine combinations added" }, "detail": { "zh": "FDA S-003 批准函增列 2.5/10、2.5/20 和 2.5/40 mg；当前 DailyMed 标签未展示这三个包装。", "en": "The FDA S-003 approval letter added 2.5/10, 2.5/20 and 2.5/40 mg; the current DailyMed label does not display these three packs." }, "source": { "id": "src_34a1d55a2d52039e", "label": "FDA：CADUET NDA 021540/S-003 增列 2.5 mg 氨氯地平组合规格批准函（2004-07-29）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21540s003ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-06-25", "title": { "zh": "当前 DailyMed 页面更新", "en": "Current DailyMed page updated" }, "detail": { "zh": "页面列八个规格、八个准确 30 片瓶装面板、NDC、外观和放大安全信息。", "en": "The page lists eight strengths, eight exact 30-tablet bottle panels, NDCs, appearances and enlarged safety information." }, "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 氨氯地平/阿托伐他汀当前美国公开标签（2026-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-28", "title": { "zh": "Orange Book 身份核验", "en": "Orange Book identity reviewed" }, "detail": { "zh": "当前数据列 11 个处方 RLD 规格，并将 10/80 mg 列为 RS。", "en": "Current data list 11 prescription RLD strengths and identify 10/80 mg as the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：CADUET，NDA 021540，11 个口服片规格列为处方 RLD；10/80 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "Orange Book 列 11 个处方 RLD 规格；10/80 mg 同时为 RS；当前 DailyMed 标签展示八个包装", "en": "Orange Book lists 11 prescription RLD strengths; 10/80 mg is also RS; current DailyMed label displays eight packs" }, "detail": { "zh": "10/10 与 10/20 mg 标签 NDC 条目列有同日营销起止日期；任何条目都不等于药房实时库存、购买资格或可替代性。", "en": "The 10/10 and 10/20 mg label NDC entries list same-day marketing start and end dates. No entry establishes real-time pharmacy stock, purchasing eligibility or interchangeability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China 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、共同成分或双数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients or paired numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "CADUET 是 NORVASC 加 LIPITOR 吗？", "en": "Is CADUET the same as NORVASC plus LIPITOR?" }, "answer": { "zh": "CADUET 一片确实含与这两个单方品牌相对应的氨氯地平和阿托伐他汀，但准确规格、标签、处方和个体安排必须逐项核对。不要自行把两盒单方替换成 CADUET，或在 CADUET 上再叠加单方。", "en": "One CADUET tablet contains amlodipine and atorvastatin, corresponding to the ingredients in those two single-ingredient brands, but exact strengths, labels, prescriptions and individual plans must be reviewed. Do not replace two single-ingredient packs with CADUET or add them to CADUET yourself." } }, { "question": { "zh": "为什么 Orange Book 有 11 个规格，而当前说明书只有八个包装？", "en": "Why does the Orange Book have 11 strengths while the current label has only eight packs?" }, "answer": { "zh": "Orange Book 还列出 2004 年增列的三个 2.5 mg 氨氯地平组合；当前 DailyMed 页面只展示 5 mg 与 10 mg 氨氯地平组合。监管身份记录、当前标签包装和实时供应是三件不同的事。", "en": "The Orange Book also lists three 2.5 mg amlodipine combinations added in 2004, while the current DailyMed page displays combinations with amlodipine 5 or 10 mg. Regulatory identity, current label packs and real-time supply are different things." } }, { "question": { "zh": "腿肿或肌肉痛时能自己停其中一个成分吗？", "en": "Can one component be stopped independently for leg swelling or muscle pain?" }, "answer": { "zh": "不能把固定复方片拆成两个可独立停用的成分。腿或踝水肿、无法解释的肌痛、压痛或无力都应带准确药盒和完整药单联系医疗团队；严重胸痛、呼吸困难、晕厥、意识异常或尿量显著减少时使用当地急救服务。", "en": "A fixed-combination tablet cannot be separated into components that can be stopped independently. Leg or ankle oedema, unexplained muscle pain, tenderness or weakness warrant contact with the care team with the exact pack and full medicine list. Use local emergency services for severe chest pain, breathing difficulty, fainting, altered consciousness or markedly reduced urine." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/caduet/", "en": "https://origindrug.com/en/drugs/caduet/" }, "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." ] }