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contains aspartame, so people with phenylketonuria need exact-label review" }, "imprint": "AMOXIL / 400", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ] }, { "id": "atorvastatin-lipitor", "names": { "brand": "Lipitor", "generic": "阿托伐他汀", "aliases": [ "立普妥", "立普妥®", "阿托伐他汀钙片", "リピトール", "atorvastatin", "atorvastatin calcium" ], "marketBrandNames": [ { "name": "立普妥®", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "current_first_party_leaflet", "note": { "zh": "晖致中国当前产品信息页列示立普妥［阿托伐他汀钙片］，其链接的 Version No. 20260119 企业说明书列示 10 mg、20 mg、40 mg。该企业公开资料可用于核对商品名、通用名、剂型、规格与说明书版本；不等于 NMPA 批准数据库、批准文号、准确包装、库存、可售资格或真伪鉴定。", "en": "Viatris China's current product-information page lists Lipitor (立普妥) [atorvastatin calcium tablets], and its linked first-party leaflet, Version No. 20260119, lists 10 mg, 20 mg and 40 mg. These company-published materials support checking the brand, generic name, form, strengths and leaflet version; they are not an NMPA approval-database record, approval number, exact package, stock, sale-eligibility record or authenticity determination." }, "source": { "id": "src_1bcca59c86bc4b38", "label": "晖致中国：立普妥®／阿托伐他汀钙片说明书 Version No. 20260119（25 页）", "url": "https://viatris.com.cn/-/media/project/viatris-sites/product-document/01atorvastatincalciumtablets.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "name": "リピトール", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前产品页列示リピトール錠 5 mg、10 mg及阿托伐他汀成分；仅用于核对日文名称、成分、剂型和市场记录，不确认其他剂型、包装、供应、可售资格或可自行换药。", "en": "The current PMDA product page lists LIPITOR (リピトール) 5 mg and 10 mg tablets with atorvastatin; it only supports checking the Japanese name, ingredient, form and market record—not another form, pack, supply, availability or self-directed switching." }, "source": { "id": "src_deb7f792025a47d6", "label": "PMDA：リピトール錠 5 mg／10 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189015F1023_2?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "mainlandChinaTradeNameCue": { "value": "立普妥®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_104aa9169b36e4d2", "label": "Pfizer China：立普妥／络活喜品牌名历史公开资料（2019）", "url": "https://www.pfizer.com.cn/zh-hans/news/press-release/619", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed SPL v8 列示 10 mg、20 mg、40 mg、80 mg；晖致中国当前产品页及 Version No. 20260119 企业说明书列示中国大陆立普妥® 10 mg、20 mg、40 mg；日本 PMDA 当前产品记录列示リピトール錠 5 mg、10 mg。三地规格与文件必须分开阅读。", "dosageFormClass": "阿托伐他汀钙口服薄膜衣片：美国 10 mg、20 mg、40 mg、80 mg；中国大陆企业说明书 10 mg、20 mg、40 mg；日本 PMDA 5 mg、10 mg。不同市场规格不合并，也不转换为个人片数。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1996", "archiveSponsorText": "晖致中国当前产品页与企业说明书；Viatris Specialty LLC / DailyMed 美国公开标签；日本 PMDA 当前产品记录" }, "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "productPresentations": [ { "id": "us-lipitor-tablet-10mg-ndc-58151-155-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v8，2026-07-15 发布", "en": "DailyMed SPL v8, published 15 Jul 2026" }, "dosageForm": { "zh": "LIPITOR 阿托伐他汀口服薄膜衣片", "en": "LIPITOR atorvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-155-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；90 片瓶装", "en": "10 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65&type=img&name=image-05.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "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": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "elliptical film-coated tablet" }, "imprint": "10 / VLE 155", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lipitor-tablet-20mg-ndc-58151-156-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v8，2026-07-15 发布", "en": "DailyMed SPL v8, published 15 Jul 2026" }, "dosageForm": { "zh": "LIPITOR 阿托伐他汀口服薄膜衣片", "en": "LIPITOR atorvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-156-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 20 mg；90 片瓶装", "en": "20 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65&type=img&name=image-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "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": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "elliptical film-coated tablet" }, "imprint": "20 / VLE 156", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lipitor-tablet-40mg-ndc-58151-157-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v8，2026-07-15 发布", "en": "DailyMed SPL v8, published 15 Jul 2026" }, "dosageForm": { "zh": "LIPITOR 阿托伐他汀口服薄膜衣片", "en": "LIPITOR atorvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-157-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 40 mg；90 片瓶装", "en": "40 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65&type=img&name=image-07.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "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": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "elliptical film-coated tablet" }, "imprint": "40 / VLE 157", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lipitor-tablet-80mg-ndc-58151-158-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v8，2026-07-15 发布", "en": "DailyMed SPL v8, published 15 Jul 2026" }, "dosageForm": { "zh": "LIPITOR 阿托伐他汀口服薄膜衣片", "en": "LIPITOR atorvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-158-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 80 mg；90 片瓶装", "en": "80 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65&type=img&name=image-08.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "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": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "elliptical film-coated tablet" }, "imprint": "80 / VLE 158", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ] }, { "id": "rosuvastatin-crestor", "names": { "brand": "CRESTOR", "generic": "瑞舒伐他汀钙", "aliases": [ "可定", "可定®", "瑞舒伐他汀", "瑞舒伐他汀钙片", "クレストール", "rosuvastatin", "rosuvastatin calcium" ], "marketBrandNames": [ { "name": "クレストール", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前产品页列示クレストール普通片与 OD 口崩片的 2.5 mg、5 mg 规格；不同剂型和市场记录不能据此自行互换。", "en": "The current PMDA product page lists CRESTOR (クレストール) 2.5 mg and 5 mg conventional and orally disintegrating tablets; different forms and market records must not be self-interchanged." }, "source": { "id": "src_eb05083a584bc9be", "label": "PMDA：クレストール錠 2.5 mg／5 mg及 OD 錠 2.5 mg／5 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189017F1022_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "name": "可定®", "market": { "zh": "中国大陆（阿斯利康中国当前产品组合页）", "en": "Mainland China (current AstraZeneca China product-portfolio page)" }, "evidenceStatus": "current_first_party_product_listing", "note": { "zh": "阿斯利康中国当前心血管、肾脏及代谢产品组合页列示可定®（瑞舒伐他汀钙片）5 mg、10 mg、20 mg。该企业页面建立品牌、通用名和规格线索，但不替代 NMPA 批准记录、现行说明书、批准文号、包装或供应核验。", "en": "AstraZeneca China's current cardiovascular, renal and metabolic product-portfolio page lists CRESTOR (可定®), rosuvastatin calcium tablets, in 5 mg, 10 mg and 20 mg strengths. 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do not break, crush or chew" }, "imprint": "NPR / EC / 375", "scoreStatus": "unscored_delayed_release_do_not_break_crush_or_chew", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22def3251c8b0839", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS 当前美国公开标签、用药指南及四个准确包装面板（2025-01-03 更新；处方信息 2024-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ec-naprosyn-naproxen-delayed-release-tablet-500mg-100-bottle-ndc-69437-416-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2025-01-03 更新；处方信息 2024-11 修订）", "en": "Current U.S. DailyMed public label (page updated 3 Jan 2025; prescribing information revised Nov 2024)" }, "dosageForm": { "zh": "EC-NAPROSYN 萘普生延迟释放口服片", "en": "EC-NAPROSYN naproxen delayed-release oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 69437-416-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片萘普生 500 mg；100 片瓶装；不是个人片数", "en": "naproxen 500 mg per tablet; 100-tablet bottle; not an individual's tablet count" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "萘普生", "en": "naproxen" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程、分片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "长椭圆形包衣片，无刻痕；不可掰开、压碎或咀嚼", "en": "oblong coated tablet without a score; do not break, crush or chew" }, "imprint": "NPR / EC / 500", "scoreStatus": "unscored_delayed_release_do_not_break_crush_or_chew", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22def3251c8b0839", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS 当前美国公开标签、用药指南及四个准确包装面板（2025-01-03 更新；处方信息 2024-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-anaprox-ds-naproxen-sodium-tablet-550mg-100-bottle-ndc-69437-203-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2025-01-03 更新；处方信息 2024-11 修订）", "en": "Current U.S. DailyMed public label (page updated 3 Jan 2025; prescribing information revised Nov 2024)" }, "dosageForm": { "zh": "ANAPROX DS 萘普生钠普通口服片", "en": "ANAPROX DS naproxen sodium conventional oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 69437-203-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片萘普生钠 550 mg，相当于萘普生 500 mg；100 片瓶装；不是个人片数", "en": "naproxen sodium 550 mg per tablet, equivalent to naproxen 500 mg; 100-tablet bottle; not an individual's tablet count" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "萘普生钠", "en": "naproxen sodium" }, "value": 550, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程、分片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深蓝色", "en": "dark blue" }, "shape": { "zh": "长椭圆形、双侧刻痕；刻痕只作准确产品外观核对", "en": "oblong with scores on both sides; the score is only an exact-product appearance clue" }, "imprint": "NPS / 550", "scoreStatus": "scored_status_not_a_self_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22def3251c8b0839", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS 当前美国公开标签、用药指南及四个准确包装面板（2025-01-03 更新；处方信息 2024-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ] }, { "id": "ventolin-hfa", "names": { "brand": "Ventolin HFA", "generic": "沙丁胺醇", "aliases": [ "albuterol", "albuterol sulfate", "salbutamol" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国公开处方药标签档案", "dosageFormClass": "定量吸入气雾剂；带计数器的吸入器（本档案所列）", "dosageFormClassCode": "inhaled_device", "route": "经口吸入", "routeCode": "inhalation", "historicalApprovalEntry": "1981（美国公开标签所列初始批准）", "archiveSponsorText": "DailyMed（NLM）公开标签档案" }, "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "productPresentations": [ { "id": "us-ventolin-hfa-albuterol-90mcg-actuation-200-inhalation-ndc-0173-0682-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2024-04-26 更新）", "en": "Current U.S. DailyMed public label (updated 26 Apr 2024)" }, "dosageForm": { "zh": "VENTOLIN HFA 沙丁胺醇定量吸入气雾剂", "en": "VENTOLIN HFA albuterol metered-dose inhalation aerosol" }, "route": { "zh": "经口吸入（标签产品身份字段）", "en": "oral inhalation (label product-identity field)" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0173-0682-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_actuation_from_mouthpiece", "primaryDisplay": { "zh": "每次从口含器喷出相当于沙丁胺醇碱 90 mcg（硫酸沙丁胺醇 108 mcg）；蓝色带计数器吸入器；200 次定量吸入，18 g", "en": "Each actuation from the mouthpiece delivers 90 mcg albuterol base (equivalent to 108 mcg albuterol sulfate); blue inhaler with counter; 200 metered inhalations, 18 g" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ventolinhfa-spl-graphic-15.jpg&setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙丁胺醇碱（每次从口含器喷出）", "en": "albuterol base (per actuation from mouthpiece)" }, "value": 90, "unit": "mcg", "basisCode": "per_actuation_from_mouthpiece", "basisLabel": { "zh": "每次定量喷射的标签标示量；不是个人吸入次数", "en": "labelled amount per metered actuation; not an individual inhalation count" } }, { "ingredient": { "zh": "硫酸沙丁胺醇（等量盐形式）", "en": "albuterol sulfate (equivalent salt form)" }, "value": 108, "unit": "mcg", "basisCode": "per_actuation_from_mouthpiece", "basisLabel": { "zh": "与 90 mcg 沙丁胺醇碱为同一次喷射的等量口径，不能相加", "en": "equivalent to 90 mcg albuterol base in the same actuation; do not add the values" } } ], "concentration": null, "container": { "typeCode": "metered_dose_inhaler", "typeLabel": { "zh": "蓝色带计数器定量吸入器", "en": "blue metered-dose inhaler with counter" }, "fill": { "value": 18, "unit": "g" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 200, "unit": { "zh": "次定量吸入/吸入器", "en": "metered inhalations per inhaler" } }, "physicalClues": { "color": { "zh": "蓝色吸入器与蓝色防尘盖", "en": "blue inhaler with blue cap" }, "shape": { "zh": "带剂量计数器的定量吸入器", "en": "metered-dose inhaler with dose counter" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4939b25c2c864e50", "label": "DailyMed（NLM）：VENTOLIN HFA 沙丁胺醇定量吸入气雾剂当前美国公开标签（2024-04-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ] }, { "id": "flomax", "names": { "brand": "FLOMAX", "generic": "坦索罗辛", "aliases": [ "Flomax", "tamsulosin", "tamsulosin hydrochloride", "tamsulosin hydrochloride capsules", "坦索罗辛", "盐酸坦索罗辛", "盐酸坦索罗辛胶囊", "NDA 020579", "0024-5837-01", "NDC 0024-5837-01", "BI 58", "Flomax 0 4 mg BI 58" ], "marketBrandNames": [ { "name": "FLOMAX", "market": { "zh": "美国历史品牌档案", "en": "U.S. historical brand archive" }, "evidenceStatus": "dated_brand_pack_marketing_ended", "note": { "zh": "NDA 020579；0.4 mg、NDC 0024-5837-01、100 粒瓶装；公开营销记录于 2025-10-31 结束。", "en": "NDA 020579; 0.4 mg, NDC 0024-5837-01, 100-capsule bottle; the public marketing record ended 31 Oct 2025." }, "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国官方资料将 FLOMAX 与 NDA 020579、坦索罗辛盐酸盐 0.4 mg 胶囊、NDC 0024-5837-01 和 100 粒瓶装相连。该品牌 NDC 的公开营销终止日期为 2025-10-31，因此本页保存的是有日期的品牌身份档案，不代表当前库存、可购买性、真伪或其他市场状态。", "dosageFormClass": "坦索罗辛盐酸盐普通口服硬胶囊 0.4 mg；0.4 mg 是每粒标签标示量，100 是所示品牌瓶内粒数。胶囊不得压碎、咀嚼或打开；这些字段不能变成个人服用、恢复、加量、停用或替换方案。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1997-04-15（美国 NDA 020579 原始批准日期）", "archiveSponsorText": "Boehringer Ingelheim Pharmaceuticals（美国 NDA 020579 品牌标签）" }, "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "productPresentations": [ { "id": "us-flomax-tamsulosin-hydrochloride-0-4mg-100-capsule-bottle-ndc-0024583701", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国品牌标签（SPL v10；2025-01-02 生效）", "en": "U.S. DailyMed brand label (SPL v10; effective 2 Jan 2025)" }, "dosageForm": { "zh": "FLOMAX 坦索罗辛盐酸盐 0.4 mg 口服硬胶囊", "en": "FLOMAX tamsulosin hydrochloride 0.4 mg oral hard capsule" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0024-5837-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒坦索罗辛盐酸盐 0.4 mg；100 粒瓶装", "en": "Tamsulosin hydrochloride 0.4 mg per capsule; 100-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "坦索罗辛盐酸盐", "en": "tamsulosin hydrochloride" }, "value": 0.4, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人服用、恢复或加量指令", "en": "labelled amount per capsule; not an individual dosing, restart or escalation instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "dated_brand_record_marketing_ended_not_live_stock", "marketingStartDate": null, "marketingEndDate": "2025-10-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "橄榄绿色不透明胶囊帽、橙色不透明胶囊体", "en": "olive-green opaque cap and orange opaque body" }, "shape": { "zh": "19 mm 硬胶囊；无刻痕；胶囊不得压碎、咀嚼或打开", "en": "19 mm hard capsule; unscored; capsule must not be crushed, chewed or opened" }, "imprint": "Flomax; 0; 4; mg; BI; 58", "scoreStatus": "unscored_do_not_crush_chew_or_open", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ] } ] }