{ "id": "vytorin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "VYTORIN", "generic": "依折麦布/辛伐他汀片", "aliases": [ "Vytorin", "ezetimibe simvastatin", "ezetimibe and simvastatin", "ezetimibe/simvastatin", "依折麦布辛伐他汀", "依折麦布辛伐他汀片", "依折麦布/辛伐他汀", "NDA 021687", "78206-174-01", "78206-174-02", "78206-175-01", "78206-175-02", "78206-176-01", "78206-176-02", "78206-177-01", "78206-177-02", "VYTORIN 311", "VYTORIN 312", "VYTORIN 313", "VYTORIN 315" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 VYTORIN 标签（2026-01-21 更新；标签正文 2024-03 修订）列示依折麦布 10 mg 与辛伐他汀 10、20、40 或 80 mg 的四个固定复方规格、八个 30 或 90 片瓶装 NDC；页面只为四个 30 片瓶装提供官方展示图，90 片瓶装保留标签文字身份卡。FDA Orange Book 2026-08-28 数据将 NDA 021687 四个规格均列为处方 RLD，并将 10/80 mg 列为 RS。监管记录、标签包装、图片和实时供应是不同证据层级。", "dosageFormClass": "依折麦布/辛伐他汀固定两成分口服片：10/10、10/20、10/40、10/80 mg；每组两个数字属于同一片内两种成分；当前标签分别列 30 与 90 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2004", "archiveSponsorText": "Organon LLC（DailyMed 当前标签及 FDA Orange Book 当前申请记录）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ZETIA", "ezetimibe tablet", "ZOCOR", "simvastatin tablet", "LIPITOR", "CRESTOR", "LIVALO", "CADUET" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-vytorin-ezetimibe-10mg-simvastatin-10mg-30-bottle-ndc-7820617401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-174-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 10 mg；30 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vytorin-04.jpg&setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 8 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 8 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "311", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/10 mg、NDC 78206-174-01、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "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-vytorin-ezetimibe-10mg-simvastatin-10mg-90-bottle-ndc-7820617402", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-174-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 10 mg；90 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 10 mg per tablet; 90-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "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": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 8 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 8 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "311", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/10 mg、NDC 78206-174-02、90 片瓶装美国公开标签文字身份记录", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "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-vytorin-ezetimibe-10mg-simvastatin-20mg-30-bottle-ndc-7820617501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-175-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 20 mg；30 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vytorin-05.jpg&setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 11 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 11 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "312", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/20 mg、NDC 78206-175-01、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "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-vytorin-ezetimibe-10mg-simvastatin-20mg-90-bottle-ndc-7820617502", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-175-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 20 mg；90 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 20 mg per tablet; 90-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "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": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 11 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 11 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "312", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/20 mg、NDC 78206-175-02、90 片瓶装美国公开标签文字身份记录", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "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-vytorin-ezetimibe-10mg-simvastatin-40mg-30-bottle-ndc-7820617601", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-176-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 40 mg；30 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vytorin-06.jpg&setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 14 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 14 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "313", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/40 mg、NDC 78206-176-01、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "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-vytorin-ezetimibe-10mg-simvastatin-40mg-90-bottle-ndc-7820617602", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-176-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 40 mg；90 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 40 mg per tablet; 90-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "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": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 14 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 14 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "313", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/40 mg、NDC 78206-176-02、90 片瓶装美国公开标签文字身份记录", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "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-vytorin-ezetimibe-10mg-simvastatin-80mg-30-bottle-ndc-7820617701", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-177-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 80 mg；30 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 80 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vytorin-07.jpg&setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 17 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 17 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "315", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/80 mg、NDC 78206-177-01、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "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-vytorin-ezetimibe-10mg-simvastatin-80mg-90-bottle-ndc-7820617702", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-177-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 80 mg；90 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 80 mg per tablet; 90-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "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": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 17 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 17 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "315", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/80 mg、NDC 78206-177-02、90 片瓶装美国公开标签文字身份记录", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "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-vytorin-ezetimibe-10mg-simvastatin-10mg-30-bottle-ndc-7820617401", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vytorin-04.jpg&setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "alt": { "zh": "DailyMed 当前 VYTORIN 10/10 mg、NDC 78206-174-01、30 片瓶装标签面板", "en": "Current DailyMed VYTORIN 10/10 mg, NDC 78206-174-01, 30-tablet bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "presentation": "VYTORIN 依折麦布 10 mg/辛伐他汀 10 mg 每片，NDC 78206-174-01，30 片瓶装。", "notice": "此图只对应 VYTORIN 10/10 mg、NDC 78206-174-01、30 片瓶装；不能代表另三个 30 片包装、四个没有独立官方展示图的 90 片包装、其他市场或仿制药，不用于鉴定真伪，也不证明实时库存或可替代性。", "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/10 mg、NDC 78206-174-01、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "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": { "status": "partial_exact_visual_coverage", "title": { "zh": "部分包装只有文字身份记录", "en": "Some pack presentations have text-only identity records" }, "summary": { "zh": "当前标签只为四个 30 片瓶装提供准确官方展示图；四个 90 片瓶装虽然有独立 NDC 和标签文字，但没有对应独立展示图，因此网页明确显示为文字身份卡。", "en": "The current label provides exact official display images only for the four 30-tablet bottles. The four 90-tablet bottles have distinct NDCs and label text but no matching display images, so the site explicitly presents them as text-only identity cards." }, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 依折麦布/辛伐他汀当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "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" } }, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VYTORIN 说明书放大阅读：一片已有依折麦布和辛伐他汀，先查是否重复降脂成分", "en": "VYTORIN label reading: one tablet already contains ezetimibe and simvastatin; first check for duplicate lipid-lowering ingredients" }, "summary": { "zh": "VYTORIN 的双数字表示同一片内两种成分。例如 10/40 mg 是依折麦布 10 mg 加辛伐他汀 40 mg，不是两片、半片或与单方药直接相加的换算式。标签要求结合完整药单、年龄、肾肝功能、甲状腺情况和相互作用逐项评估；网页不会替个人选择规格。", "en": "The paired numbers identify two ingredients in one VYTORIN tablet. For example, 10/40 mg means ezetimibe 10 mg plus simvastatin 40 mg; it is not two tablets, half a tablet or a conversion formula for adding single-ingredient products. The label requires review of the full medicine list, age, kidney and liver function, thyroid status and interactions; the site does not choose an individual strength." }, "checks": [ { "zh": "先逐盒核对成分。ZETIA 是单方依折麦布，ZOCOR 是单方辛伐他汀；LIPITOR、CRESTOR、LIVALO 与 CADUET 还含其他他汀。疑似重复可能是误用，也可能是专业人员有意安排；不要自行叠加、隔天轮换或停掉任何一盒。", "en": "Check active ingredients on every pack. ZETIA is ezetimibe alone and ZOCOR is simvastatin alone; LIPITOR, CRESTOR, LIVALO and CADUET contain other statins. Suspected duplication may be accidental or intentionally prescribed. Do not combine, alternate by day or stop a pack yourself." }, { "zh": "年龄 ≥65 岁、甲状腺功能未控制、肾功能受损、使用某些相互作用药物或较高规格，会增加标签所述肌病和横纹肌溶解风险；当前标签还提示中国患者风险可能更高。出现无法解释的肌痛、压痛或无力，尤其伴发热、全身不适或深色尿，应尽快联系医疗团队；症状严重、迅速加重、意识异常或尿量显著减少时使用当地急救服务。", "en": "Age 65 years or older, uncontrolled hypothyroidism, renal impairment, certain interacting medicines and higher strengths increase the labelled risk of myopathy and rhabdomyolysis; the current label also says Chinese patients may be at higher risk. Promptly contact the care team for unexplained muscle pain, tenderness or weakness, especially with fever, malaise or dark urine; use local emergency services for severe or rapidly worsening symptoms, altered consciousness or markedly reduced urine." }, { "zh": "10/80 mg 在当前标签和 Orange Book 中仍有记录，但标签把它限制在特定长期耐受情形，并明确较高规格有更高肌病风险。网页不会把 RS 身份或包装存在解释为适合开始、升级或继续该规格。", "en": "The current label and Orange Book still record 10/80 mg, but the label restricts it to defined chronic-tolerance circumstances and states that higher strengths carry greater myopathy risk. The site does not interpret RS status or pack existence as permission to start, increase to or continue this strength." }, { "zh": "当前标签列出强 CYP3A4 抑制剂、环孢素、达那唑、吉非贝齐、胺碘酮、地尔硫卓、氨氯地平、秋水仙碱和葡萄柚汁等重要相互作用边界。不要依据网页自行停药、错开时间或改变规格；让药师按准确产品、食物/饮品、补充剂和完整药单核对。", "en": "The current label identifies important interaction boundaries involving strong CYP3A4 inhibitors, cyclosporine, danazol, gemfibrozil, amiodarone, diltiazem, amlodipine, colchicine and grapefruit juice. Do not use the site to stop a medicine, schedule separation or change a strength; have a pharmacist review the exact products, foods or drinks, supplements and complete medicine list." }, { "zh": "急性肝衰竭或失代偿性肝硬化属于标签禁忌边界。明显乏力、食欲下降、右上腹不适、深色尿或黄疸需要及时医疗评估；网页不读取化验值来决定继续、暂停或改量。", "en": "Acute liver failure or decompensated cirrhosis is a labelled contraindication boundary. Marked fatigue, loss of appetite, right-upper-abdominal discomfort, dark urine or jaundice needs timely medical assessment; the site does not read laboratory values to decide continuation, interruption or adjustment." }, { "zh": "怀孕可能造成胎儿伤害，使用期间不建议哺乳。已经怀孕、可能怀孕、计划怀孕或正在哺乳者应及时联系开方团队核对，不自行停换药。", "en": "Pregnancy may cause fetal harm and breastfeeding is not recommended during treatment. Anyone who is pregnant, may be pregnant, plans pregnancy or is breastfeeding should contact the prescribing team promptly and should not arrange stopping or switching independently." }, { "zh": "四种片剂均为白色至类白色、胶囊形且无刻痕，印字分别为 311、312、313、315。印字只帮助区分标签内规格，不能单独鉴定真伪；无刻痕也不表示可以自行掰开或磨碎。", "en": "All four tablets are white to off-white, capsule-shaped and unscored, with imprints 311, 312, 313 and 315. Imprints only help distinguish strengths within this label and cannot authenticate a product alone; unscored tablets do not establish permission to split or crush them." } ], "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 依折麦布/辛伐他汀当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样分工：依折麦布减少小肠胆固醇吸收，辛伐他汀影响肝脏胆固醇合成路径", "en": "How the two ingredients differ: ezetimibe reduces intestinal cholesterol absorption while simvastatin acts on the hepatic cholesterol-synthesis pathway" }, "summary": { "zh": "当前标签把依折麦布描述为在小肠刷状缘抑制 NPC1L1 介导的胆固醇吸收，把辛伐他汀描述为经活化后抑制 HMG-CoA 还原酶。两条互补路径在一片中组合，不表示所有人都需要复方，也不允许把其他他汀或单方依折麦布自行拼接成同一方案。", "en": "The current label describes ezetimibe as inhibiting NPC1L1-mediated cholesterol absorption at the intestinal brush border and simvastatin as inhibiting HMG-CoA reductase after activation. Two complementary pathways in one tablet do not mean everyone needs the combination or permit self-assembly from another statin and single-ingredient ezetimibe." }, "checks": [ { "zh": "依折麦布作用于胆固醇吸收路径，辛伐他汀作用于胆固醇合成路径；作用点不同不等于副作用互相抵消，也不等于可以在其他他汀上自行加药。", "en": "Ezetimibe acts on cholesterol absorption and simvastatin on cholesterol synthesis. Different targets do not cancel adverse effects or permit self-adding the medicine to another statin." }, { "zh": "四个强度的依折麦布成分均为每片 10 mg，变化的是辛伐他汀成分。不能只看前一个或后一个数字判断等效，更不能按总毫克数与 CADUET、LIPITOR、CRESTOR 或 ZOCOR 换算。", "en": "The ezetimibe component is 10 mg per tablet in all four strengths; the simvastatin component changes. Neither number nor their total establishes equivalence, and they cannot be converted by milligrams to CADUET, LIPITOR, CRESTOR or ZOCOR." }, { "zh": "基因结果可能在特定临床场景帮助专业人员理解他汀暴露或肌病风险，但网页不会据商品名推荐全基因筛查，也不会用单一基因结果替代完整药单、症状、肾肝功能和临床评估。", "en": "Genetic results may help professionals interpret statin exposure or myopathy risk in defined clinical settings, but the site does not recommend broad genetic screening from a brand name or replace the full medicine list, symptoms, kidney and liver function and clinical assessment with one genetic result." } ], "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 依折麦布/辛伐他汀当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "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": "VYTORIN", "generic": "依折麦布/辛伐他汀片", "dosageFormClass": "依折麦布/辛伐他汀固定两成分口服片：10/10、10/20、10/40、10/80 mg；每组两个数字属于同一片内两种成分；当前标签分别列 30 与 90 片瓶装" }, "labelSource": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 依折麦布/辛伐他汀当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "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_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 依折麦布/辛伐他汀当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：VYTORIN，NDA 021687，四个口服片规格列为处方 RLD；10/80 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：VYTORIN NDA 021687 申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "VYTORIN 一片同时含依折麦布和辛伐他汀：前一个数字固定表示依折麦布 10 mg，后一个数字表示辛伐他汀强度。它既不是单方 ZETIA，也不是单方 ZOCOR。若药单还出现这些单方药、其他他汀（如 LIPITOR、CRESTOR、LIVALO、CADUET）或相互作用药物，应带所有药盒、处方和完整药单让药师或开方团队核对，不要自行叠加、轮换、停药、掰片或按毫克换算。", "history": "FDA Orange Book 将 VYTORIN NDA 021687 的四个规格批准日期列为 2004-07-23。FDA 原始医学审评文件说明该固定复方含依折麦布 10 mg 与辛伐他汀 10、20、40 或 80 mg，并以单方资料与复方研究支持审评。当前 DailyMed 标签页面更新于 2026-01-21，标签正文修订日期为 2024-03；历史批准、现行标签和实时供应不能混写。", "sourceDocuments": [ { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 依折麦布/辛伐他汀当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：VYTORIN，NDA 021687，四个口服片规格列为处方 RLD；10/80 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：VYTORIN NDA 021687 申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_dfce1bf241b32c66", "label": "FDA：VYTORIN NDA 021687 原始医学审评文件（2004）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-687_Vytorin_Medr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 021687（VYTORIN / ezetimibe and simvastatin oral tablets）", "approvalTimeline": [ { "date": "2004-07-23", "title": { "zh": "VYTORIN 四个固定复方规格获批", "en": "Four fixed VYTORIN strengths approved" }, "detail": { "zh": "FDA Orange Book 当前数据把 10/10、10/20、10/40 和 10/80 mg 的批准日期均列为 2004-07-23；原始医学审评文件说明四种固定复方的开发与审评依据。", "en": "Current FDA Orange Book data list 23 Jul 2004 as the approval date for 10/10, 10/20, 10/40 and 10/80 mg; the original medical review describes the development and review basis for the four fixed combinations." }, "source": { "id": "src_dfce1bf241b32c66", "label": "FDA：VYTORIN NDA 021687 原始医学审评文件（2004）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-687_Vytorin_Medr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-01-21", "title": { "zh": "当前 DailyMed 页面更新", "en": "Current DailyMed page updated" }, "detail": { "zh": "页面列四个强度、八个瓶装 NDC、四个 30 片官方展示面板、片剂外观和放大安全信息；标签正文修订日期仍为 2024-03。", "en": "The page lists four strengths, eight bottle NDCs, four official 30-tablet display panels, tablet appearances and enlarged safety information; the label revision date remains Mar 2024." }, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 依折麦布/辛伐他汀当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-28", "title": { "zh": "Orange Book 身份核验", "en": "Orange Book identity reviewed" }, "detail": { "zh": "当前数据列四个处方 RLD 规格，并将 10/80 mg 列为 RS。", "en": "Current data list four prescription RLD strengths and identify 10/80 mg as the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：VYTORIN，NDA 021687，四个口服片规格列为处方 RLD；10/80 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "Orange Book 四个规格均为处方 RLD；10/80 mg 同时为 RS；当前 DailyMed 标签列八个瓶装 NDC", "en": "All four Orange Book strengths are prescription RLD products; 10/80 mg is also RS; current DailyMed label lists eight bottle NDCs" }, "detail": { "zh": "四个 30 片瓶装有官方展示图；四个 90 片瓶装只有标签文字身份。任何记录都不等于药房实时库存、购买资格、适合个人使用或可替代性。", "en": "Four 30-tablet bottles have official display images; four 90-tablet bottles have label-text identity only. No record establishes real-time pharmacy stock, purchasing eligibility, individual suitability or interchangeability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、共同成分或双数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients or paired numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "VYTORIN 是 ZETIA 加 ZOCOR 吗？", "en": "Is VYTORIN the same as ZETIA plus ZOCOR?" }, "answer": { "zh": "VYTORIN 一片含与这两个单方品牌相对应的依折麦布和辛伐他汀，但准确规格、标签、处方和个体安排必须逐项核对。不要自行把两盒单方替换成 VYTORIN，或在 VYTORIN 上再叠加单方。", "en": "One VYTORIN tablet contains ezetimibe and simvastatin, corresponding to the ingredients in those two single-ingredient brands, but exact strengths, labels, prescriptions and individual plans must be reviewed. Do not replace two single-ingredient packs with VYTORIN or add them to VYTORIN yourself." } }, { "question": { "zh": "为什么同一规格有 30 片和 90 片两个 NDC，却只显示一张图？", "en": "Why does one strength have 30- and 90-tablet NDCs but only one image?" }, "answer": { "zh": "当前标签为两种包装分别列出 NDC，但官方展示面板只对应 30 片瓶装。网页因此为 90 片瓶装保留文字身份卡，而不重复使用会造成误认的 30 片图片。", "en": "The current label lists separate NDCs for both packs, but the official display panel corresponds only to the 30-tablet bottle. The site therefore keeps the 90-tablet bottle as a text-only identity card rather than reusing a misleading 30-tablet image." } }, { "question": { "zh": "正在吃其他他汀，还能再吃 VYTORIN 吗？", "en": "Can VYTORIN be taken with another statin?" }, "answer": { "zh": "网页不能只凭药名回答个人联用问题。VYTORIN 本身已经含辛伐他汀；其他他汀、单方依折麦布及多种相互作用药都需要按准确药盒、处方、剂型、强度、症状和完整药单由药师或开方团队核对，不要自行叠加、轮换或停换药。", "en": "The site cannot answer an individual's combination question from medicine names alone. VYTORIN already contains simvastatin; another statin, single-ingredient ezetimibe and many interacting medicines require review of the exact packs, prescriptions, forms, strengths, symptoms and full medicine list by a pharmacist or prescribing team. Do not combine, rotate, stop or switch them yourself." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/vytorin/", "en": "https://origindrug.com/en/drugs/vytorin/" }, "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." ] }