{ "id": "naprosyn", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "NAPROSYN", "generic": "萘普生／萘普生钠", "aliases": [ "Naprosyn", "EC-NAPROSYN", "ANAPROX DS", "naproxen", "naproxen sodium", "萘普生", "萘普生钠", "naproxen tablets", "萘普生片", "NAPROSYN", "NDA 017581", "NDA 018164", "NDA 020067", "69437-316-01", "69437-415-01", "69437-416-01", "69437-203-01", "NPR LE 500", "NPR EC 375", "NPR EC 500", "NPS 550" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国 DailyMed 当前公开标签同时列出 NAPROSYN 萘普生普通片 500 mg、EC-NAPROSYN 萘普生延迟释放片 375 mg/500 mg、ANAPROX DS 萘普生钠片 550 mg。三个商品名、两种化学形式、两种释放设计和四个包装必须分开核对；公开标签与 NDC 不证明当前库存或适合个人使用。", "dosageFormClass": "口服片：NAPROSYN 500 mg 是普通萘普生片；EC-NAPROSYN 375/500 mg 是延迟释放肠溶片，必须保持包衣完整；ANAPROX DS 550 mg 是萘普生钠片，标签注明相当于萘普生 500 mg并含 50 mg 钠。它们不是按包装数字自行互换、叠加或分片的算术题。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1976（美国初始批准）", "archiveSponsorText": "Atnahs Pharma US Limited（标签持有人）／Canton Laboratories（美国分销标签）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "NAPROSYN", "EC-NAPROSYN", "ANAPROX DS", "萘普生片", "萘普生钠片" ], "excludedProductCues": [ "ALEVE", "naproxen sodium 220 mg OTC", "NAPRELAN", "VIMOVO", "generic naproxen product", "generic naproxen sodium product" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-naprosyn-naproxen-tablet-500mg-100-bottle-ndc-69437-316-01", "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": "NAPROSYN 萘普生普通口服片", "en": "NAPROSYN naproxen 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 69437-316-01", "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": "黄色", "en": "yellow" }, "shape": { "zh": "胶囊形、单侧刻痕；刻痕只作准确产品外观核对", "en": "capsule-shaped with a score on one side; the score is only an exact-product appearance clue" }, "imprint": "NPR / LE / 500", "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": "us-ec-naprosyn-naproxen-delayed-release-tablet-375mg-100-bottle-ndc-69437-415-01", "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 69437-415-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片萘普生 375 mg；100 片瓶装；不是个人片数", "en": "naproxen 375 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": 375, "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": "椭圆形双凸包衣片，无刻痕；不可掰开、压碎或咀嚼", "en": "oval biconvex coated tablet without a score; 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" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "四个包装身份有来源文字，但图片端点当前返回空响应", "en": "Four package identities have source text, but their image endpoints currently return empty responses" }, "summary": { "zh": "DailyMed 标签页列出 NAPROSYN 500 mg、EC-NAPROSYN 375/500 mg 与 ANAPROX DS 550 mg 的四个 100 片瓶装身份及对应图片文件名；2026-09-04 逐一复核时，四个图片端点均返回 200 状态但正文为 0 字节且类型为 text/html，因此网页暂不展示这些图片，也不以截图、零售图或相似药片代替。药名、剂型、强度、NDC、刻字和来源链接仍按四个产品分别保留。", "en": "The DailyMed label page lists four 100-tablet identities for NAPROSYN 500 mg, EC-NAPROSYN 375/500 mg and ANAPROX DS 550 mg with corresponding image filenames. On individual checks dated 4 Sep 2026, every image endpoint returned HTTP 200 but a zero-byte text/html body. The site therefore withholds these images and does not substitute screenshots, retail images or look-alike tablets. Brand, dosage form, strength, NDC, imprint and source link remain separated for all four products." }, "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" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "NAPROSYN 说明书放大阅读：先防重复 NSAID，再看胃肠道、心血管、肾脏和水肿", "en": "NAPROSYN enlarged label: prevent duplicate NSAIDs, then review gastrointestinal, cardiovascular, kidney and oedema risks" }, "summary": { "zh": "黑便、呕血、胸痛、气短、单侧无力或言语不清、脸或喉咙肿胀、明显少尿、快速水肿或起疱脱皮都不是靠网页继续试药的情形，应及时使用当地医疗支持。老人、既往溃疡或出血、肾病、心衰、脱水或多药同用者尤其需要先核对完整药单。", "en": "Black stools, vomiting blood, chest pain, shortness of breath, one-sided weakness or speech difficulty, face or throat swelling, markedly reduced urine, rapid swelling, blistering or skin erosion are not situations for continued self-trial from a webpage and require timely local medical support. Older adults and people with prior ulcer or bleeding, kidney disease, heart failure, dehydration or multiple medicines need priority full-list review." }, "checks": [ { "zh": "NAPROSYN、EC-NAPROSYN、ANAPROX DS、ALEVE 及其他萘普生产品会共享萘普生活性部分；标签明确不应同时使用。布洛芬、双氯芬酸、塞来昔布、依托考昔和止痛剂量阿司匹林等其他 NSAID 也不能只按商品名自行叠加。", "en": "NAPROSYN, EC-NAPROSYN, ANAPROX DS, ALEVE and other naproxen products share the naproxen active moiety; the label says naproxen-containing products should not be used together. Other NSAIDs such as ibuprofen, diclofenac, celecoxib, etoricoxib or analgesic-dose aspirin must not be self-combined by brand name." }, { "zh": "EC-NAPROSYN 是延迟释放肠溶片，必须保持包衣完整，不得掰开、压碎或咀嚼。NAPROSYN 与 ANAPROX DS 的刻痕是准确产品外观线索；是否分片仍属于具体处方和准确产品核对，不是网页普遍许可。", "en": "EC-NAPROSYN is a delayed-release enteric-coated tablet whose coating must remain intact; do not break, crush or chew it. Scores on NAPROSYN and ANAPROX DS identify the exact product. Any splitting still belongs to the exact prescription and product review, not general permission from this site." }, { "zh": "华法林、阿司匹林、氯吡格雷等影响止血的药，SSRI/SNRI 抗抑郁药、ACEI/ARB、利尿剂、地高辛、锂、甲氨蝶呤、环孢素及其他 NSAID 都需要结合完整药单核对；网页不自动生成错开或停药方案。", "en": "Warfarin, aspirin, clopidogrel and other medicines affecting haemostasis, SSRI/SNRI antidepressants, ACE inhibitors/ARBs, diuretics, digoxin, lithium, methotrexate, ciclosporin and other NSAIDs require review against the complete medicine list. The site does not generate a separation or stopping plan." }, { "zh": "NAPROSYN 500 mg、EC-NAPROSYN 500 mg 和 ANAPROX DS 550 mg 即使都与萘普生相关，也不是相同释放方式或相同化学形式；不同剂型和强度不能凭 mg 自行互换。", "en": "NAPROSYN 500 mg, EC-NAPROSYN 500 mg and ANAPROX DS 550 mg are all naproxen-related but do not share the same release pattern or chemical form. Different formulations and strengths are not self-interchangeable from milligram numbers." }, { "zh": "老人发生 NSAID 相关严重胃肠道、心血管和肾脏不良反应的风险更高。使用前应把处方药、非处方止痛药、感冒药、阿司匹林和保健品一并交给药师核对。", "en": "Older adults have higher risk of serious NSAID-associated gastrointestinal, cardiovascular and kidney reactions. Prescriptions, OTC pain or cold products, aspirin and supplements should be reviewed together by a pharmacist." } ], "source": { "id": "src_a0e33da540d57841", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS FDA 批准 NSAID 患者用药指南", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "萘普生怎样起作用：抑制 COX-1/COX-2 与前列腺素合成", "en": "How naproxen works: inhibition of COX-1/COX-2 and prostaglandin synthesis" }, "summary": { "zh": "标签说明其机制尚未完全阐明，但涉及抑制环氧合酶 COX-1 和 COX-2，减少外周组织的前列腺素。前列腺素参与疼痛和炎症，也参与胃肠道、肾脏、血小板及妊娠相关生理，因此“能止痛”不能与风险阅读分开。", "en": "The label states that the mechanism is not fully understood but involves inhibition of cyclooxygenase COX-1 and COX-2 and reduced prostaglandin synthesis in peripheral tissues. Prostaglandins participate in pain and inflammation as well as gastrointestinal, kidney, platelet and pregnancy-related physiology, so analgesic action cannot be separated from risk reading." }, "checks": [ { "zh": "ANAPROX DS 的钠盐设计吸收更快，EC-NAPROSYN 的肠溶设计延迟吸收；吸收模式不同正是不能按相近 mg 自行替换的原因之一。", "en": "The sodium-salt design of ANAPROX DS is absorbed more rapidly, while the enteric design of EC-NAPROSYN delays absorption. Different absorption patterns are one reason similar milligram numbers do not permit self-substitution." }, { "zh": "COX/前列腺素机制不能用来判断某个人该选哪一种 NSAID、该吃几片或能否和阿司匹林同服。", "en": "The COX/prostaglandin mechanism cannot determine which NSAID an individual should use, a tablet count, or whether aspirin can be co-used." }, { "zh": "同属 NSAID 不代表可以轮换或叠加；共同机制反而提示需要先排查重复成分与胃肠道、心血管和肾脏风险。", "en": "Membership in the NSAID class does not permit rotation or combination. The shared mechanism instead signals the need to check duplication and gastrointestinal, cardiovascular and kidney risks first." } ], "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": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "NAPROSYN", "generic": "萘普生／萘普生钠", "dosageFormClass": "口服片：NAPROSYN 500 mg 是普通萘普生片；EC-NAPROSYN 375/500 mg 是延迟释放肠溶片，必须保持包衣完整；ANAPROX DS 550 mg 是萘普生钠片，标签注明相当于萘普生 500 mg并含 50 mg 钠。它们不是按包装数字自行互换、叠加或分片的算术题。" }, "labelSource": { "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" }, "productRoutes": [ { "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" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "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": "NAPROSYN、EC-NAPROSYN 和 ANAPROX DS 都会在体内形成萘普生相关活性成分，但普通片、延迟释放片与钠盐产品不是可以凭 mg 自行替换的同一包装。老人先看胃肠道出血、心脑血管、肾功能、水肿与完整药单；不要与 ALEVE、布洛芬、其他 NSAID 或另一种萘普生产品自行叠加。", "history": "美国标签列示初始批准年份为 1976。2024-11，FDA 批准三个 NDA 的安全标签修订；DailyMed 当前页面于 2025-01-03 更新。当前公开标签由 Atnahs Pharma US Limited 制造委托信息及 Canton Laboratories 美国分销信息承载；这些标签实体与历史批准记录不等于任何市场的实时库存或购买资格。", "sourceDocuments": [ { "id": "src_a0e33da540d57841", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS FDA 批准 NSAID 患者用药指南", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "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" }, { "id": "src_ea056d3880cfca1c", "label": "FDA：NAPROSYN NDA 017581、ANAPROX DS NDA 018164、EC-NAPROSYN NDA 020067 的 2024 年补充申请批准函", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017581Orig1s117%2C018164Orig1s067%2C020067Orig1s026ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NAPROSYN NDA 017581；ANAPROX DS NDA 018164；EC-NAPROSYN NDA 020067", "approvalTimeline": [ { "date": "1976", "title": { "zh": "美国标签所列初始批准年份", "en": "Initial U.S. approval year listed in the label" }, "detail": { "zh": "当前 DailyMed 标签列示 Initial U.S. Approval: 1976；该年份只定位美国品牌历史，不外推其他市场。", "en": "The current DailyMed label lists Initial U.S. Approval: 1976. This only locates U.S. brand history and is not extrapolated to another market." }, "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" } }, { "date": "2024-11-21", "title": { "zh": "FDA 批准三个 NDA 的安全标签补充申请", "en": "FDA approved safety-labelling supplements for three NDAs" }, "detail": { "zh": "批准函分别标识 NDA 017581/S-117、018164/S-067 与 020067/S-026，并附修订处方信息与用药指南。", "en": "The approval letter identifies NDA 017581/S-117, 018164/S-067 and 020067/S-026 and encloses revised prescribing information and Medication Guide." }, "source": { "id": "src_ea056d3880cfca1c", "label": "FDA：NAPROSYN NDA 017581、ANAPROX DS NDA 018164、EC-NAPROSYN NDA 020067 的 2024 年补充申请批准函", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017581Orig1s117%2C018164Orig1s067%2C020067Orig1s026ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-01-03", "title": { "zh": "DailyMed 当前公开标签页面更新", "en": "Current DailyMed public-label page updated" }, "detail": { "zh": "页面列出四个准确 NDC、每片标示量、外观、包装面板和 2024-11 修订标签。", "en": "The page lists four exact NDCs, labelled amounts per tablet, appearance, package panels and the Nov 2024 revised label." }, "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" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开标签与四个准确 NDC/包装面板已链接", "en": "Current public label and four exact NDC/package panels linked" }, "detail": { "zh": "公开监管档案不等于当前库存、购买渠道、真伪鉴定或个人适用性。", "en": "A public regulatory record does not establish current stock, purchase channel, authenticity or individual suitability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立当地现行市场记录", "en": "Current local market record not yet established" }, "detail": { "zh": "不从美国 NDA、NDC、英文品牌或包装图推定当地批准、商品名、供应、原研/仿制关系或可替代性。", "en": "No local approval, brand, supply, originator/generic relationship or interchangeability is inferred from a U.S. NDA, NDC, English brand or package image." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "NAPROSYN 500 mg 和 ANAPROX DS 550 mg 是一回事吗？", "en": "Are NAPROSYN 500 mg and ANAPROX DS 550 mg the same product?" }, "answer": { "zh": "不是同一个准确产品。前者每片含萘普生 500 mg；后者每片含萘普生钠 550 mg，标签注明相当于萘普生 500 mg并含 50 mg 钠。共同活性部分不建立自行换算、替换、叠加或选择片数的许可。", "en": "They are not the same exact product. The first contains naproxen 500 mg per tablet; the second contains naproxen sodium 550 mg, labelled as equivalent to naproxen 500 mg and containing 50 mg sodium. A shared active moiety does not permit self-conversion, substitution, combination or tablet-count selection." } }, { "question": { "zh": "EC-NAPROSYN 可以掰开或磨碎吗？", "en": "Can EC-NAPROSYN be split or crushed?" }, "answer": { "zh": "不能。当前标签明确要求保持肠溶包衣完整，不得掰开、压碎或咀嚼。若吞咽困难，应携带准确药盒与处方联系药师或开方团队，不要自行改造剂型。", "en": "No. The current label requires the enteric coating to remain intact and says not to break, crush or chew the tablet. For swallowing difficulty, take the exact pack and prescription to a pharmacist or prescriber rather than altering the dosage form." } }, { "question": { "zh": "已经用了 ALEVE、布洛芬或阿司匹林，还能再用 NAPROSYN 吗？", "en": "Can NAPROSYN be added if ALEVE, ibuprofen or aspirin is already being used?" }, "answer": { "zh": "不要自行叠加。ALEVE 可能已经含萘普生钠；布洛芬和阿司匹林也属于需要优先核对的 NSAID/止血相关药。请把所有处方药、非处方药、感冒止痛复方和保健品交给药师按准确产品逐项检查。", "en": "Do not self-combine them. ALEVE may already contain naproxen sodium; ibuprofen and aspirin are also priority NSAID/haemostasis review medicines. Give all prescriptions, OTC products, cold/pain combinations and supplements to a pharmacist for exact-product review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "same-class-is-not-same-medicine", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/naprosyn/", "en": "https://origindrug.com/en/drugs/naprosyn/" }, "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." ] }