{ "id": "coreg-cr", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "COREG CR", "generic": "磷酸卡维地洛缓释胶囊", "aliases": [ "Coreg CR", "carvedilol phosphate", "carvedilol phosphate extended-release capsules", "磷酸卡维地洛", "磷酸卡维地洛缓释胶囊", "卡维地洛缓释胶囊", "carvedilol phosphate extended release", "NDA 022012", "80725-383-13", "80725-385-13", "80725-387-13", "80725-388-13", "COREG CR 10 mg", "COREG CR 20 mg", "COREG CR 40 mg", "COREG CR 80 mg" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 COREG CR 标签列出 10、20、40、80 mg 四种磷酸卡维地洛口服缓释胶囊和四个准确 30 粒瓶装面板；FDA Orange Book 将 NDA 022012 四个规格均列为处方 RLD，RS 均为 No。监管在册、官方包装图和具体药房实时库存属于不同证据层级。", "dosageFormClass": "磷酸卡维地洛口服缓释胶囊：10 mg、20 mg、40 mg、80 mg；不是 COREG 卡维地洛普通片的另一种包装", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2006-10-20（FDA NDA 022012 原始申请批准）", "archiveSponsorText": "Waylis Therapeutics LLC（DailyMed 与 FDA 当前美国监管记录）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "COREG CR", "Coreg CR", "磷酸卡维地洛缓释胶囊" ], "excludedProductCues": [ "COREG carvedilol tablets", "carvedilol immediate-release tablets", "卡维地洛片", "卡维地洛普通片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-coreg-cr-carvedilol-phosphate-10mg-30-capsule-bottle-ndc-8072538313", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（SPL v3；2025-04-25 生效）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed label (SPL v3; effective 25 Apr 2025); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "COREG CR 磷酸卡维地洛口服缓释胶囊", "en": "COREG CR carvedilol phosphate oral extended-release capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-383-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒磷酸卡维地洛 10 mg；30 粒瓶装", "en": "10 mg carvedilol phosphate per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=coreg-07.jpg&setid=d3625d78-6eb6-41fe-8f6f-664965c104c4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "磷酸卡维地洛", "en": "carvedilol phosphate" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是 COREG 普通片换算值或个人粒数", "en": "labelled amount per capsule; not a COREG immediate-release conversion or individual capsule count" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色／绿色", "en": "white / green" }, "shape": { "zh": "胶囊，约 14 mm；胶囊接缝不是可分剂量刻痕", "en": "capsule, approximately 14 mm; the capsule seam is not a dose-dividing score" }, "imprint": "GSLGK;10mg", "scoreStatus": "capsule_not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "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-coreg-cr-carvedilol-phosphate-20mg-30-capsule-bottle-ndc-8072538513", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（SPL v3；2025-04-25 生效）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed label (SPL v3; effective 25 Apr 2025); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "COREG CR 磷酸卡维地洛口服缓释胶囊", "en": "COREG CR carvedilol phosphate oral extended-release capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-385-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒磷酸卡维地洛 20 mg；30 粒瓶装", "en": "20 mg carvedilol phosphate per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=coreg-08.jpg&setid=d3625d78-6eb6-41fe-8f6f-664965c104c4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "磷酸卡维地洛", "en": "carvedilol phosphate" }, "value": 20, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是 COREG 普通片换算值或个人粒数", "en": "labelled amount per capsule; not a COREG immediate-release conversion or individual capsule count" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色／黄色", "en": "white / yellow" }, "shape": { "zh": "胶囊，约 16 mm；胶囊接缝不是可分剂量刻痕", "en": "capsule, approximately 16 mm; the capsule seam is not a dose-dividing score" }, "imprint": "GSMHV;20mg", "scoreStatus": "capsule_not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "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-coreg-cr-carvedilol-phosphate-40mg-30-capsule-bottle-ndc-8072538713", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（SPL v3；2025-04-25 生效）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed label (SPL v3; effective 25 Apr 2025); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "COREG CR 磷酸卡维地洛口服缓释胶囊", "en": "COREG CR carvedilol phosphate oral extended-release capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-387-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒磷酸卡维地洛 40 mg；30 粒瓶装", "en": "40 mg carvedilol phosphate per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=coreg-09.jpg&setid=d3625d78-6eb6-41fe-8f6f-664965c104c4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "磷酸卡维地洛", "en": "carvedilol phosphate" }, "value": 40, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是 COREG 普通片换算值或个人粒数", "en": "labelled amount per capsule; not a COREG immediate-release conversion or individual capsule count" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "绿色／黄色", "en": "green / yellow" }, "shape": { "zh": "胶囊，约 18 mm；胶囊接缝不是可分剂量刻痕", "en": "capsule, approximately 18 mm; the capsule seam is not a dose-dividing score" }, "imprint": "GSETX;40mg", "scoreStatus": "capsule_not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "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-coreg-cr-carvedilol-phosphate-80mg-30-capsule-bottle-ndc-8072538813", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（SPL v3；2025-04-25 生效）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed label (SPL v3; effective 25 Apr 2025); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "COREG CR 磷酸卡维地洛口服缓释胶囊", "en": "COREG CR carvedilol phosphate oral extended-release capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-388-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒磷酸卡维地洛 80 mg；30 粒瓶装", "en": "80 mg carvedilol phosphate per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=coreg-10.jpg&setid=d3625d78-6eb6-41fe-8f6f-664965c104c4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "磷酸卡维地洛", "en": "carvedilol phosphate" }, "value": 80, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是 COREG 普通片换算值或个人粒数", "en": "labelled amount per capsule; not a COREG immediate-release conversion or individual capsule count" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊，约 22 mm；胶囊接缝不是可分剂量刻痕", "en": "capsule, approximately 22 mm; the capsule seam is not a dose-dividing score" }, "imprint": "GSF1L;80mg", "scoreStatus": "capsule_not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "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-coreg-cr-carvedilol-phosphate-10mg-30-capsule-bottle-ndc-8072538313", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=coreg-07.jpg&setid=d3625d78-6eb6-41fe-8f6f-664965c104c4&type=img", "alt": "COREG CR 磷酸卡维地洛 10 mg、NDC 80725-383-13、30 粒瓶装的美国 DailyMed 官方标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v3；2025-04-25 生效", "presentation": "COREG CR 每粒磷酸卡维地洛 10 mg，白色／绿色胶囊，NDC 80725-383-13，30 粒瓶装。", "notice": "此图只对应当前美国标签中的 10 mg、NDC 80725-383-13、30 粒瓶装；不代表 20、40、80 mg、COREG 普通片、其他市场包装、实时库存或个人粒数，不用于鉴定真伪。", "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "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": "COREG CR 说明书放大阅读：缓释胶囊不是普通片；微丸必须保持完整", "en": "COREG CR label reading: an extended-release capsule is not an immediate-release tablet; keep the beads intact" }, "summary": { "zh": "先核对 COREG CR、磷酸卡维地洛、缓释胶囊、准确强度和 NDC。标签中的专业转换表需要开方团队结合年龄、头晕、低血压和晕厥风险执行，网页不会据此给出个人换算。", "en": "Check COREG CR, carvedilol phosphate, extended-release capsule, exact strength and NDC. The label's professional conversion table requires prescriber oversight with age, dizziness, hypotension and syncope risk; the site does not turn it into an individual conversion." }, "checks": [ { "zh": "标签要求随餐服用，不要压碎或咀嚼胶囊。吞咽困难时，可小心打开一整粒，把全部微丸撒在一匙不温热的苹果酱上立即全部吃完；混合物不能储存，未测试撒在其他食物上的吸收。不要分微丸、估算半粒或研碎缓释颗粒。", "en": "The label says to take it with food and not crush or chew the capsule. For swallowing difficulty, one whole capsule may be carefully opened and all beads sprinkled over a spoonful of applesauce that is not warm, then consumed immediately in its entirety. Do not store the mixture; absorption on other foods has not been tested. Do not divide, estimate half a capsule or grind the extended-release beads." }, { "zh": "COREG 是卡维地洛普通片，COREG CR 是磷酸卡维地洛缓释胶囊。标签虽然提供医务人员使用的转换表，但老年人或低血压、头晕、晕厥风险较高者可能需要不同起始考虑。不要按品牌词根、普通片每日总 mg、CR 胶囊 mg 或服用频次自行换算、叠加、轮换或替换。", "en": "COREG is an immediate-release carvedilol tablet; COREG CR is an extended-release carvedilol phosphate capsule. Although the label contains a clinician conversion table, older people or those at higher risk of hypotension, dizziness or syncope may require a different starting approach. Do not self-convert, combine, alternate or substitute from a brand stem, daily immediate-release milligrams, CR capsule milligrams or frequency." }, { "zh": "不要突然停用。标签提示 β 受体阻滞剂突然停用可能使心绞痛加重，并可能发生心肌梗死或室性心律失常。不要因一次血压或脉搏读数自行停药；胸痛、昏厥、严重气促或其他急性严重表现应立即使用当地急救。", "en": "Do not stop abruptly. The label warns that abrupt beta-blocker withdrawal may worsen angina and may be followed by myocardial infarction or ventricular arrhythmia. Do not stop from one blood-pressure or pulse reading; use local emergency care immediately for chest pain, fainting, severe breathlessness or another acute severe feature." }, { "zh": "脉搏过慢、体位性头晕、晕厥、低血压、体重或水肿快速变化需要及时联系治疗团队。标签显示，65 岁以上从最高剂量普通片切换到最高剂量 CR 的试验组，头晕、低血压或晕厥合并发生率更高；这正是不能让网页自动换算的原因。", "en": "A slow pulse, postural dizziness, fainting, hypotension or rapid change in weight or swelling requires prompt contact with the care team. The label reports a higher combined rate of dizziness, hypotension or syncope in people over 65 switched from the highest immediate-release dose to the highest CR dose; this is why a website must not automate conversion." }, { "zh": "把地高辛、可乐定、胺碘酮、氟西汀/帕罗西汀、维拉帕米/地尔硫卓、其他 β 受体阻滞剂、降糖药和全部非处方药/补充剂一起核对。标签提示心率、传导、低血压、地高辛浓度、低血糖警示被掩盖等边界；不要自行错开或先停其中一种。", "en": "Review digoxin, clonidine, amiodarone, fluoxetine/paroxetine, verapamil/diltiazem, another beta blocker, glucose-lowering medicines and all OTC/supplement products together. The label flags heart rate, conduction, hypotension, digoxin concentration and masking of hypoglycaemia warnings; do not self-separate or decide which medicine to stop first." } ], "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "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": "磷酸卡维地洛怎样起作用：体内释放卡维地洛，兼有 α1 与非选择性 β 阻断", "en": "How carvedilol phosphate works: it provides carvedilol with alpha-1 and nonselective beta blockade" }, "summary": { "zh": "当前标签说明卡维地洛具有 α1 阻断和非选择性 β 肾上腺素能阻断活性。机制有助于理解为什么心率、血压、传导、体液状态、呼吸和血糖需要一起核对，但不能产生个人剂量、转换表或停换药方案。", "en": "The current label describes carvedilol as having alpha-1 blocking and nonselective beta-adrenergic blocking activity. This helps explain why heart rate, blood pressure, conduction, fluid status, breathing and glucose need joint review, but it cannot produce an individual dose, conversion table or stop/switch plan." }, "checks": [ { "zh": "缓释设计改变药物释放过程，同一活性部分不等于 COREG 普通片与 COREG CR 胶囊可以毫克对毫克替换。", "en": "Extended release changes the delivery process; a shared active moiety does not make COREG immediate-release tablets and COREG CR capsules milligram-for-milligram substitutes." }, { "zh": "标签列 CYP2D6、CYP2C9 和 P-gp 相关相互作用线索；基因或代谢酶名词不是自行调整、停用精神科药或默认进行全基因组检测的依据。", "en": "The label provides CYP2D6, CYP2C9 and P-gp interaction cues. A gene or enzyme name is not a basis for self-adjustment, stopping psychiatric medicine or default whole-genome testing." }, { "zh": "完整药单和实际药盒比单独看一次心率、血压或商品名更重要。任何调整都应由熟悉病情的医生和药师结合症状、监测、年龄及肝肾功能判断。", "en": "The complete medicine list and actual packs matter more than one heart-rate or blood-pressure reading or a brand name. Any change belongs with clinicians and pharmacists who can review symptoms, monitoring, age and liver/kidney function." } ], "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "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": "COREG CR", "generic": "磷酸卡维地洛缓释胶囊", "dosageFormClass": "磷酸卡维地洛口服缓释胶囊：10 mg、20 mg、40 mg、80 mg；不是 COREG 卡维地洛普通片的另一种包装" }, "labelSource": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "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_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "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：COREG CR NDA 022012 的 10／20／40／80 mg 均列为处方 RLD，RS 均为 No（数据复核日 2026-08-30）", "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." } } ], "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": "COREG CR 是磷酸卡维地洛缓释胶囊，不是 COREG 卡维地洛普通片。两个产品虽共享品牌词根和卡维地洛活性部分，但剂型、标示成分形式、释放方式和毫克数字不能自行一对一换算。当前标签要求随餐服用，不能压碎或咀嚼；吞咽困难时只允许按标签打开整粒，把全部微丸撒在一匙不温热的苹果酱上立即全部吃完，不能只吃一部分或储存。老人、低脉搏、头晕/晕厥、糖尿病和多种减慢心率药同用时应优先核对。网页不生成个人转换表、粒数、频次、停药或补服方案。", "history": "FDA Drugs@FDA 数据记录 NDA 022012 原始申请于 2006-10-20 批准。当前 DailyMed 标签于 2025-04-25 生效，并列四个 30 粒瓶装 NDC。标签中的 Initial U.S. Approval: 1995 是卡维地洛产品历史，不是 COREG CR 在 1995 年获批。COREG 普通片另属 NDA 020297 和即释片档案，两个页面必须分开阅读。", "sourceDocuments": [ { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "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：COREG CR NDA 022012 的 10／20／40／80 mg 均列为处方 RLD，RS 均为 No（数据复核日 2026-08-30）", "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_25a85c5faf3af303", "label": "FDA Drugs@FDA：COREG CR NDA 022012 产品与批准记录（原始申请 2006-10-20 批准）", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022012", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "approval_history", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 022012（COREG CR／carvedilol phosphate extended-release capsules）", "approvalTimeline": [ { "date": "2006-10-20", "title": { "zh": "FDA 批准 COREG CR 原始申请", "en": "FDA approved the original COREG CR application" }, "detail": { "zh": "Drugs@FDA 数据记录 NDA 022012 原始申请批准；当前 Orange Book 仍列四个处方 RLD 规格，RS 均为 No。", "en": "Drugs@FDA data record approval of the original NDA 022012 application; the current Orange Book still lists four prescription RLD strengths, none designated RS." }, "source": { "id": "src_25a85c5faf3af303", "label": "FDA Drugs@FDA：COREG CR NDA 022012 产品与批准记录（原始申请 2006-10-20 批准）", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022012", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "approval_history", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2025-04-25", "title": { "zh": "当前 DailyMed 标签生效", "en": "Current DailyMed label became effective" }, "detail": { "zh": "SPL v3 列出四个规格、四个 30 粒瓶装 NDC、随餐要求、完整微丸苹果酱给药规则和更新的安全信息。", "en": "SPL v3 lists four strengths, four 30-capsule bottle NDCs, the with-food requirement, the all-beads applesauce option and updated safety information." }, "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "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": "2026-08-30", "title": { "zh": "Orange Book 产品身份复核", "en": "Orange Book product identity reviewed" }, "detail": { "zh": "四个规格均为处方 RLD，RS 均为 No；该字段不表示个人首选或可自行换药。", "en": "All four strengths are prescription RLD products and none is the RS; these fields do not establish individual preference or self-switching." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：COREG CR NDA 022012 的 10／20／40／80 mg 均列为处方 RLD，RS 均为 No（数据复核日 2026-08-30）", "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": "四个处方 RLD 规格当前列示；四个准确 30 粒瓶装面板", "en": "Four prescription RLD strengths currently listed; four exact 30-capsule bottle panels" }, "detail": { "zh": "NDC 80725-383-13、-385-13、-387-13、-388-13 分别对应 10、20、40、80 mg。监管在册和图像不证明药房实时库存、购买资格或个人适用性。", "en": "NDCs 80725-383-13, -385-13, -387-13 and -388-13 correspond to 10, 20, 40 and 80 mg. Regulatory listing and images do not establish live pharmacy stock, purchasing eligibility or individual suitability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行产品记录", "en": "Current product record not established" }, "detail": { "zh": "不从美国品牌、NDA、胶囊颜色或 mg 数字推定当地批准、商品名、供应、原研/参比关系或可替代性。", "en": "No local approval, brand, supply, originator/reference relationship or interchangeability is inferred from a U.S. brand, NDA, capsule colour or milligram figure." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "COREG CR 胶囊可以打开吃一半吗？", "en": "Can a COREG CR capsule be opened and half taken?" }, "answer": { "zh": "不能。当前标签只允许为吞咽困难打开一整粒，并把全部微丸撒在一匙不温热的苹果酱上立即全部吃完；不能分半、估算颗粒、压碎、咀嚼或储存。", "en": "No. The current label only allows opening one whole capsule for swallowing difficulty and sprinkling all beads on a spoonful of applesauce that is not warm for immediate complete consumption. Do not halve, estimate beads, crush, chew or store." } }, { "question": { "zh": "COREG 普通片和 COREG CR 能按毫克直接换吗？", "en": "Can COREG tablets and COREG CR be switched directly by milligrams?" }, "answer": { "zh": "不能自行换。现行标签有供专业人员使用的转换信息，但年龄、头晕、低血压和晕厥风险会改变起始考虑。请带两盒药和完整药单让开方团队核对，网页不提供个人转换表。", "en": "Not by self-direction. The current label includes clinician conversion information, but age and risks of dizziness, hypotension and syncope alter the starting approach. Take both packs and the full medicine list to the prescribing team; the site provides no individual conversion table." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "family-medicine-list-for-pharmacist" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/coreg-cr/", "en": "https://origindrug.com/en/drugs/coreg-cr/" }, "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." ] }