{ "id": "calan-verapamil-immediate-release", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "CALAN / verapamil immediate-release", "generic": "盐酸维拉帕米普通片", "aliases": [ "CALAN", "Calan", "verapamil", "verapamil hydrochloride", "verapamil tablets", "维拉帕米", "盐酸维拉帕米", "盐酸维拉帕米片", "异搏定", "NDA 018817", "ANDA 071881", "62135-743-90", "62135-744-90", "62135-745-90", "HP59", "HP 26", "HP 27" ], "marketBrandNames": [ { "name": "CALAN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 018817 历史原研/RLD；40、80、120、160 mg 普通片当前列入 DISCN，且标注并非因安全性或有效性撤回。本页不展示历史原品牌包装。", "en": "Historical originator/RLD under NDA 018817. The 40, 80, 120 and 160 mg immediate-release tablets are listed as DISCN and marked as not withdrawn for safety or effectiveness. This page does not display a historical original-brand pack." }, "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：CALAN NDA 018817 的 40／80／120／160 mg 口服普通片列入 Discontinued Drug Product List", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "name": "verapamil hydrochloride tablets", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "Chartwell RX ANDA 071881 当前通用药标签；40、80、120 mg 各一个 90 片瓶装。监管标签不等于实时库存。", "en": "Current Chartwell RX generic label under ANDA 071881: one 90-tablet bottle each for 40, 80 and 120 mg. A regulatory label is not live stock." }, "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "FDA Orange Book 第 46 版把 CALAN NDA 018817 的 40、80、120、160 mg 口服普通片列入停市清单，并以脚注注明并非因安全性或有效性撤回。当前准确包装来自 Chartwell RX ANDA 071881 通用药标签：40、80、120 mg，各一个 90 片瓶装与对应准确包装面板。历史品牌、当前通用药及不同释放/给药产品不得混写。", "dosageFormClass": "盐酸维拉帕米普通口服片；CALAN SR、VERELAN、VERELAN PM、COVERA-HS、ISOPTIN SR 等缓释或节律释放产品以及注射剂均是不同准确产品。共同通用名或 mg 数字不建立换算、频次、分片、叠加或替换结论。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1984（CALAN 美国口服普通片 NDA 018817 的 80／120 mg 批准年份）", "archiveSponsorText": "CALAN 历史原研/RLD（Pfizer／G.D. Searle）；Chartwell RX, LLC 为当前展示通用药标签方" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "CALAN", "verapamil", "verapamil hydrochloride", "verapamil tablets", "维拉帕米", "盐酸维拉帕米", "盐酸维拉帕米片", "异搏定" ], "excludedProductCues": [ "CALAN SR", "VERELAN", "VERELAN PM", "COVERA-HS", "ISOPTIN SR", "verapamil extended release", "verapamil injection", "维拉帕米缓释", "维拉帕米注射液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-generic-verapamil-ir-40mg-90-tablet-bottle-ndc-6213574390", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（页面 2025-12-10 更新；正文 Revised 08/2023）", "en": "Current U.S. DailyMed generic label (page updated 10 Dec 2025; text revised Aug 2023)" }, "dosageForm": { "zh": "盐酸维拉帕米普通薄膜衣口服片", "en": "verapamil hydrochloride immediate-release film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62135-743-90", "pouchCode": null, "applicationNumber": "ANDA 071881", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸维拉帕米 40 mg；90 片瓶装", "en": "40 mg verapamil hydrochloride per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=verapamil-hcl-tablets-usp-40mg-bottle-label.jpg&setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸维拉帕米", "en": "verapamil hydrochloride" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、分片指令，也不是与 CALAN SR、VERELAN、VERELAN PM、其他缓释制剂或注射剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to CALAN SR, VERELAN, VERELAN PM, another extended-release product or an injection" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通薄膜衣片", "en": "round immediate-release film-coated tablet" }, "imprint": "HP59", "scoreStatus": "unscored_no_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-verapamil-ir-80mg-90-tablet-bottle-ndc-6213574490", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（页面 2025-12-10 更新；正文 Revised 08/2023）", "en": "Current U.S. DailyMed generic label (page updated 10 Dec 2025; text revised Aug 2023)" }, "dosageForm": { "zh": "盐酸维拉帕米普通薄膜衣口服片", "en": "verapamil hydrochloride immediate-release film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62135-744-90", "pouchCode": null, "applicationNumber": "ANDA 071881", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸维拉帕米 80 mg；90 片瓶装", "en": "80 mg verapamil hydrochloride per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=verapamil-hcl-tablets-usp-80mg-bottle-label.jpg&setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸维拉帕米", "en": "verapamil hydrochloride" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、分片指令，也不是与 CALAN SR、VERELAN、VERELAN PM、其他缓释制剂或注射剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to CALAN SR, VERELAN, VERELAN PM, another extended-release product or an injection" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通薄膜衣片", "en": "round immediate-release film-coated tablet" }, "imprint": "HP;26", "scoreStatus": "scored_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-verapamil-ir-120mg-90-tablet-bottle-ndc-6213574590", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（页面 2025-12-10 更新；正文 Revised 08/2023）", "en": "Current U.S. DailyMed generic label (page updated 10 Dec 2025; text revised Aug 2023)" }, "dosageForm": { "zh": "盐酸维拉帕米普通薄膜衣口服片", "en": "verapamil hydrochloride immediate-release film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62135-745-90", "pouchCode": null, "applicationNumber": "ANDA 071881", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸维拉帕米 120 mg；90 片瓶装", "en": "120 mg verapamil hydrochloride per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=verapamil-hcl-tablets-usp-120mg-bottle-label.jpg&setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸维拉帕米", "en": "verapamil hydrochloride" }, "value": 120, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、分片指令，也不是与 CALAN SR、VERELAN、VERELAN PM、其他缓释制剂或注射剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to CALAN SR, VERELAN, VERELAN PM, another extended-release product or an injection" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通薄膜衣片", "en": "round immediate-release film-coated tablet" }, "imprint": "HP;27", "scoreStatus": "scored_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-generic-verapamil-ir-40mg-90-tablet-bottle-ndc-6213574390", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=verapamil-hcl-tablets-usp-40mg-bottle-label.jpg&setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28&type=img", "alt": "Chartwell RX 盐酸维拉帕米 40 mg、NDC 62135-743-90、90 片瓶装的 DailyMed 官方通用药标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国通用药标签（2025 页面更新）", "presentation": "40 mg：白色圆形、无刻痕、印有 HP59；NDC 62135-743-90，90 片瓶装。", "notice": "此图是当前通用药包装标签，不是 CALAN 历史原品牌包装；只对应 NDC 62135-743-90，不代表 80/120 mg、CALAN SR、VERELAN、VERELAN PM、其他缓释产品、注射剂、其他厂商或其他市场，也不用于鉴定真伪。", "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "盐酸维拉帕米说明书放大阅读：每片 mg、整瓶片数、心率传导、便秘与多药核对", "en": "Verapamil enlarged label: per-tablet mg, bottle count, heart rate/conduction, constipation and medicine-list review" }, "summary": { "zh": "40、80、120 mg 是每片含量；90 Tablets 是整瓶片数。当前 40 mg 通用药片无刻痕，80/120 mg 有刻痕，但刻痕只是准确产品外观与标签线索，不自动构成自行掰片许可；历史 CALAN 80 mg 的刻痕标签也不能推广到其他厂商、规格或缓释产品。", "en": "The 40, 80 and 120 mg figures are amounts per tablet; 90 Tablets is the bottle count. The current 40 mg generic tablet is unscored and the 80/120 mg tablets are scored, but a score is an exact-product appearance and label clue, not automatic permission to self-split. Historical CALAN 80 mg score labelling cannot be extended to another manufacturer, strength or extended-release product." }, "checks": [ { "zh": "低血压、眩晕、晕厥、心动过缓或房室传导阻滞可能增加跌倒和急性风险。老人、多药使用者或已有心率/传导问题者应把脉搏、症状、全部药盒和处方一起交给医生或药师核对；严重晕厥、胸痛、呼吸困难或意识异常应使用当地急救。", "en": "Hypotension, dizziness, syncope, bradycardia or atrioventricular block can increase fall and acute risk. Older adults, people using several medicines or those with heart-rate/conduction problems should have pulse, symptoms, every pack and the prescription reviewed together. Severe fainting, chest pain, breathing difficulty or altered awareness needs local emergency care." }, { "zh": "标签警示心衰和心肌收缩受影响；与 β 受体阻滞剂、地高辛、可乐定、胺碘酮或其他影响心率/传导/血压的药同时出现时，不要自行错开、加减、轮换或先停其中一种。", "en": "The label warns about heart failure and impaired cardiac contractility. If a beta blocker, digoxin, clonidine, amiodarone or another heart-rate/conduction/blood-pressure medicine is also present, do not self-space, add, reduce, alternate or choose one to stop first." }, { "zh": "便秘是常见不良反应，标签还记录罕见非梗阻性麻痹性肠梗阻。持续腹胀、剧烈腹痛、呕吐或无法排气排便需要及时医疗评估，不能仅在网页上寻找通便方案。", "en": "Constipation is common, and the label also records rare non-obstructive paralytic ileus. Persistent distension, severe abdominal pain, vomiting or inability to pass gas or stool needs timely medical assessment, not only a web search for a laxative plan." }, { "zh": "标签列出与辛伐他汀、洛伐他汀及其他 CYP3A4 底物/抑制剂、地高辛、锂、葡萄柚汁等的相互作用线索。网页不根据两个药名或食物名决定能否同用、怎样减量或怎样错开。", "en": "The label lists interaction cues with simvastatin, lovastatin and other CYP3A4 substrates/inhibitors, digoxin, lithium and grapefruit juice. The site does not decide co-use, dose reduction or timing from two medicine or food names." }, { "zh": "普通片与 CALAN SR、VERELAN、VERELAN PM、COVERA-HS 等产品的释放方式和标签不同；不要把相同通用名、相近 mg 或‘一天一次’等文字当作换算表。", "en": "Immediate-release tablets and products such as CALAN SR, VERELAN, VERELAN PM and COVERA-HS differ in release and labelling. Do not treat a shared generic name, similar milligrams or wording such as once daily as a conversion table." } ], "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "维拉帕米怎样起作用：阻断慢钙通道会同时影响血管、心肌和心脏传导", "en": "How verapamil works: slow calcium-channel blockade affects vessels, myocardium and cardiac conduction" }, "summary": { "zh": "说明书将维拉帕米归为钙离子流入抑制剂/慢通道阻滞剂。它可影响动脉平滑肌，也影响心肌收缩与传导细胞；这有助理解降压、心率变慢、传导阻滞和心衰风险为何要一起看，但不能预测个人反应或生成剂量。", "en": "The label classifies verapamil as a calcium-ion influx inhibitor/slow-channel blocker. It can affect arterial smooth muscle, myocardial contraction and conduction cells. This helps explain why blood pressure, slower heart rate, conduction block and heart-failure risk must be reviewed together, but it cannot predict an individual's response or generate a dose." }, "checks": [ { "zh": "与地尔硫卓同属非二氢吡啶类钙通道阻滞剂，不代表两者可以按 mg 互换、同日轮换或叠加；它们仍是不同成分、产品、标签和处方。", "en": "Sharing the nondihydropyridine calcium-channel-blocker class with diltiazem does not permit milligram conversion, same-day alternation or combination. They remain different ingredients, products, labels and prescriptions." }, { "zh": "共同降低心率或血压不等于可与 β 受体阻滞剂、地高辛、可乐定或胺碘酮自行叠加。心率、心电传导、心功能、血压、肝功能和完整药单需要一起核对。", "en": "A shared effect on heart rate or pressure does not permit self-combining verapamil with a beta blocker, digoxin, clonidine or amiodarone. Heart rate, ECG conduction, cardiac function, pressure, liver function and the complete medicine list need joint review." }, { "zh": "作用机制不能决定谁适合维拉帕米，也不能从一次血压或脉搏读数决定加量、减量或停药。网页只帮助识别准确产品、来源和说明书边界。", "en": "Mechanism cannot decide who is suited to verapamil or use one blood-pressure or pulse reading to decide an increase, decrease or stop. The site only helps identify the exact product, source and label boundary." } ], "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CALAN / verapamil immediate-release", "generic": "盐酸维拉帕米普通片", "dosageFormClass": "盐酸维拉帕米普通口服片；CALAN SR、VERELAN、VERELAN PM、COVERA-HS、ISOPTIN SR 等缓释或节律释放产品以及注射剂均是不同准确产品。共同通用名或 mg 数字不建立换算、频次、分片、叠加或替换结论。" }, "labelSource": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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_c3b83a27bd081a53", "label": "FDA：CALAN（verapamil hydrochloride）NDA 018817 历史口服普通片标签（2009 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018817s021lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：CALAN NDA 018817 的 40／80／120／160 mg 口服普通片列入 Discontinued Drug Product List", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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": "2026-09-02", "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": "CALAN 是盐酸维拉帕米普通片的美国历史原研/RLD；本页可见包装属于当前通用药，不是 CALAN 原品牌。40/80/120 mg 是每片含量，90 Tablets 是整瓶片数。说明书重点涉及低血压、心动过缓、房室传导阻滞、心衰、便秘和跌倒，以及与 β 受体阻滞剂、地高辛、可乐定、辛伐他汀/洛伐他汀、葡萄柚和多种 CYP3A4 相关药物的核对。网页不生成个人片数、频次、分片、错开或换药方案。", "history": "CALAN 普通片的 80 mg 与 120 mg 于 1984 年在美国获批，40 mg 与 160 mg 于 1988 年获批。2021 年 FDA 补充批准信涉及现有 80 mg 刻痕的功能与拆分后储存标签更新；这只属于准确 CALAN 产品的专业标签记录，不能推广为任何维拉帕米片都能自行掰开。当前 DailyMed 页面展示的是 ANDA 071881 通用药三个 90 片瓶装，不是历史 CALAN 包装。", "sourceDocuments": [ { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_c3b83a27bd081a53", "label": "FDA：CALAN（verapamil hydrochloride）NDA 018817 历史口服普通片标签（2009 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018817s021lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_46eb030128963fbd", "label": "FDA：CALAN NDA 018817／S-035 补充批准信（2021；80 mg 刻痕功能与标签更新）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018817Orig1s035ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：CALAN NDA 018817 的 40／80／120／160 mg 口服普通片列入 Discontinued Drug Product List", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "CALAN NDA 018817（历史原研/RLD）；verapamil hydrochloride ANDA 071881（当前通用药标签）", "approvalTimeline": [ { "date": "1984-09-10", "title": { "zh": "CALAN 80／120 mg 普通片在美国获批", "en": "U.S. approval of CALAN 80/120 mg immediate-release tablets" }, "detail": { "zh": "FDA Orange Book 记录 NDA 018817 的 80 mg 与 120 mg 于 1984 年获批。", "en": "The FDA Orange Book records approval of NDA 018817 80 mg and 120 mg tablets in 1984." }, "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：CALAN NDA 018817 的 40／80／120／160 mg 口服普通片列入 Discontinued Drug Product List", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "1988-02-23", "title": { "zh": "CALAN 40／160 mg 普通片获批", "en": "Approval of CALAN 40/160 mg immediate-release tablets" }, "detail": { "zh": "FDA Orange Book 记录 NDA 018817 的 40 mg 与 160 mg 于 1988 年获批。", "en": "The FDA Orange Book records approval of NDA 018817 40 mg and 160 mg tablets in 1988." }, "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：CALAN NDA 018817 的 40／80／120／160 mg 口服普通片列入 Discontinued Drug Product List", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2021-06-22", "title": { "zh": "FDA 批准 80 mg 刻痕功能标签更新", "en": "FDA approved the 80 mg score-function labelling update" }, "detail": { "zh": "补充批准信只支持准确 CALAN 80 mg 产品的标签历史，不为其他维拉帕米片建立通用分片许可。", "en": "The supplement letter supports the exact CALAN 80 mg product's labelling history and does not create general splitting permission for other verapamil tablets." }, "source": { "id": "src_46eb030128963fbd", "label": "FDA：CALAN NDA 018817／S-035 补充批准信（2021；80 mg 刻痕功能与标签更新）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018817Orig1s035ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2025-12-10", "title": { "zh": "当前 Chartwell RX 通用药页面更新", "en": "Current Chartwell RX generic page updated" }, "detail": { "zh": "ANDA 071881 当前页面列出 40／80／120 mg 三个 90 片瓶装及准确包装面板。", "en": "The current ANDA 071881 page lists three 90-tablet bottles for 40, 80 and 120 mg with exact package panels." }, "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国 CALAN 普通片", "en": "United States — CALAN immediate-release tablets" }, "status": { "zh": "历史原研/RLD，已停市", "en": "Historical originator/RLD; discontinued" }, "detail": { "zh": "NDA 018817；40、80、120、160 mg 均列入 DISCN，并以脚注注明并非因安全性或有效性撤回。", "en": "NDA 018817; 40, 80, 120 and 160 mg are listed as DISCN and footnoted as not withdrawn for safety or effectiveness." } }, { "market": { "zh": "美国当前通用药", "en": "United States — current generic" }, "status": { "zh": "当前公开通用药标签", "en": "Current public generic label" }, "detail": { "zh": "ANDA 071881；40／80／120 mg，各一个 90 片瓶装。", "en": "ANDA 071881; one 90-tablet bottle each for 40, 80 and 120 mg." } }, { "market": { "zh": "缓释、节律释放与注射剂", "en": "Extended-release, chronotherapeutic and injectable products" }, "status": { "zh": "不同准确产品", "en": "Separate exact products" }, "detail": { "zh": "CALAN SR、VERELAN、VERELAN PM、COVERA-HS、ISOPTIN SR 和注射剂不并入本普通片档案，也不建立换算。", "en": "CALAN SR, VERELAN, VERELAN PM, COVERA-HS, ISOPTIN SR and injections are not merged into this immediate-release dossier and no conversion is established." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地品牌、规格、包装或供应", "en": "Local brand, strength, pack and supply are not established" }, "detail": { "zh": "异搏定等当地名称必须按当地药监记录、现行说明书和手中药盒逐项核对。", "en": "Local names such as Isoptin must be checked item by item against the local regulator, current label and pack in hand." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "照片里的是 CALAN 原研药瓶吗？", "en": "Is the pictured bottle the original CALAN product?" }, "answer": { "zh": "不是。图片是 Chartwell RX ANDA 071881 当前通用药包装面板；CALAN 只作为历史原研/RLD 身份展示。", "en": "No. The image is a current Chartwell RX generic package panel under ANDA 071881. CALAN is shown only as the historical originator/RLD identity." } }, { "question": { "zh": "90 Tablets 是一次吃 90 片吗？", "en": "Does 90 Tablets mean taking 90 tablets at once?" }, "answer": { "zh": "不是。90 Tablets 是整瓶片数；40／80／120 mg 才是每片标签含量。网页不会把瓶数或 mg 变成个人片数或频次。", "en": "No. 90 Tablets is the bottle count; 40/80/120 mg is the labelled amount per tablet. The site does not turn bottle count or milligrams into an individual's tablet count or frequency." } }, { "question": { "zh": "有刻痕就一定可以掰开吗？", "en": "Does a score always mean the tablet can be split?" }, "answer": { "zh": "不能这样判断。刻痕属于准确产品的外观和标签信息；是否可分、分后如何保存及是否符合处方，都必须核对具体厂家现行标签、处方和药师意见。缓释产品尤其不能借普通片刻痕自行处理。", "en": "No. A score is exact-product appearance and label information. Splitting, storage after splitting and prescription fit require the exact manufacturer's current label, prescription and pharmacist review. An immediate-release score must never be extended to an extended-release product." } }, { "question": { "zh": "维拉帕米和地尔硫卓可以轮换吗？", "en": "Can verapamil and diltiazem be alternated?" }, "answer": { "zh": "网页不能据同类药身份建立轮换或换算。两者都是不同成分和处方，且都可能影响心率、传导、血压与相互作用；需要完整药单和临床情况共同评估。", "en": "The site cannot create alternation or conversion from a shared class. They are different ingredients and prescriptions, and both can affect heart rate, conduction, pressure and interactions; the complete medicine list and clinical context require joint review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/calan-verapamil-immediate-release/", "en": "https://origindrug.com/en/drugs/calan-verapamil-immediate-release/" }, "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." ] }