{ "id": "voltaren-xr-diclofenac", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "VOLTAREN-XR", "generic": "双氯芬酸钠缓释片", "aliases": [ "Voltaren XR", "Voltaren", "Cataflam", "diclofenac", "diclofenac sodium", "diclofenac potassium", "双氯芬酸", "双氯芬酸钠", "双氯芬酸钾", "扶他林", "diclofenac sodium extended release", "diclofenac sodium extended-release tablets", "双氯芬酸钠缓释片", "VOLTAREN-XR", "VOLTAREN", "CATAFLAM", "NDA 020254", "ANDA 216275", "0078-0446-05", "80425-0414-01", "80425-0414-02", "80425-0414-03", "ING 278" ], "marketBrandNames": [ { "name": "VOLTAREN-XR", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 020254、100 mg 缓释片、历史 RLD，当前 DISCN；不表示当前品牌供应。", "en": "NDA 020254, 100 mg extended-release tablet, historical RLD and currently DISCN; this does not establish current brand supply." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：VOLTAREN、VOLTAREN-XR 与 CATAFLAM 历史 RLD 产品记录（2026-08-26 数据）", "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" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国 FDA Orange Book 将 VOLTAREN-XR 双氯芬酸钠 100 mg 缓释片 NDA 020254 列为历史 RLD、当前 DISCN；2021 有日期品牌标签保留一个 100 片瓶装文字身份。DailyMed 当前仿制品标签另列 ANDA 216275 的 30、60、90 片三个瓶装身份及准确面板。历史品牌标签、当前仿制品标签、官方包装图和实时库存属于不同证据层级。", "dosageFormClass": "双氯芬酸钠 100 mg 缓释口服片；VOLTAREN 双氯芬酸钠延迟释放片、CATAFLAM 双氯芬酸钾普通片、外用凝胶和滴眼液均为不同准确产品，标签明确不同口服剂型即使 mg 相同也未必生物等效", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1996-03-08（FDA NDA 020254 批准日期）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation（历史 VOLTAREN-XR NDA）；Ingenus Pharmaceuticals／Advanced Rx of Tennessee（当前仿制品比较项）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "VOLTAREN-XR", "Voltaren XR", "双氯芬酸钠缓释片" ], "excludedProductCues": [ "VOLTAREN Arthritis Pain topical gel", "VOLTAREN ophthalmic solution", "diclofenac topical", "diclofenac sodium delayed-release tablets", "CATAFLAM diclofenac potassium immediate-release tablets" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-historical-voltaren-xr-diclofenac-sodium-er-100mg-100-tablet-bottle-ndc-0078044605", "marketCode": "US", "labelVersion": { "zh": "FDA 2021-04 有日期 VOLTAREN-XR 品牌标签（历史档案）", "en": "Dated Apr 2021 FDA VOLTAREN-XR brand label (historical archive)" }, "dosageForm": { "zh": "VOLTAREN-XR 双氯芬酸钠 100 mg 缓释口服片（历史品牌）", "en": "VOLTAREN-XR diclofenac sodium 100 mg extended-release oral tablet (historical brand)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0446-05", "pouchCode": null, "applicationNumber": "NDA 020254 Product 001", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片双氯芬酸钠 100 mg；100 片瓶装；历史 RLD、当前 DISCN", "en": "Diclofenac sodium 100 mg per tablet; 100-tablet bottle; historical RLD, currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "双氯芬酸钠", "en": "diclofenac sodium" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "历史品牌标签的每片标示量；不是当前供应或个人片数", "en": "per-tablet amount in the historical brand label; not current supply or an individual tablet count" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "历史 100 片瓶装", "en": "historical 100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_rld_discontinued", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅粉红色", "en": "light pink" }, "shape": { "zh": "圆形、双凸、斜边薄膜衣片；仅作 2021 历史标签外观文字核对", "en": "round, biconvex, bevel-edged film-coated tablet; text-only appearance from the 2021 historical label" }, "imprint": "Voltaren-XR / 100", "scoreStatus": "unscored_historical_text_only", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_676dec4d45e823d1", "label": "FDA：VOLTAREN-XR 双氯芬酸钠 100 mg 缓释片有日期品牌标签（2021-04 修订；历史标签，不代表当前品牌供应）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020254s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diclofenac-sodium-er-100mg-30-tablet-bottle-ndc-80425041401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国仿制品标签（2024-07-16 发布；处方信息 2023-10 修订）", "en": "Current U.S. DailyMed generic label (published 16 Jul 2024; prescribing information revised Oct 2023)" }, "dosageForm": { "zh": "双氯芬酸钠 100 mg 缓释口服片（仿制品比较项）", "en": "diclofenac sodium 100 mg extended-release oral tablet (generic comparator)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80425-0414-01", "pouchCode": null, "applicationNumber": "ANDA 216275", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片双氯芬酸钠 100 mg；30 片瓶装", "en": "Diclofenac sodium 100 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Diclofenac+Sodium+ER+100mg+80425-0414-01.jpg&setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "双氯芬酸钠", "en": "diclofenac sodium" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数，也不是与普通片、延迟释放片或钾盐产品的换算值", "en": "labelled amount per tablet; not an individual tablet count or a conversion to immediate-release, delayed-release or potassium-salt products" } } ], "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": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、凸面、9 mm、无刻痕；无刻痕与缓释身份都不是网页提供的分片许可", "en": "round, convex, 9 mm and unscored; neither the unscored appearance nor the extended-release identity is web permission to split" }, "imprint": "ING / 278", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diclofenac-sodium-er-100mg-60-tablet-bottle-ndc-80425041402", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国仿制品标签（2024-07-16 发布；处方信息 2023-10 修订）", "en": "Current U.S. DailyMed generic label (published 16 Jul 2024; prescribing information revised Oct 2023)" }, "dosageForm": { "zh": "双氯芬酸钠 100 mg 缓释口服片（仿制品比较项）", "en": "diclofenac sodium 100 mg extended-release oral tablet (generic comparator)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80425-0414-02", "pouchCode": null, "applicationNumber": "ANDA 216275", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片双氯芬酸钠 100 mg；60 片瓶装", "en": "Diclofenac sodium 100 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Diclofenac+Sodium+ER+100mg+80425-0414-02.jpg&setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "双氯芬酸钠", "en": "diclofenac sodium" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数，也不是与普通片、延迟释放片或钾盐产品的换算值", "en": "labelled amount per tablet; not an individual tablet count or a conversion to immediate-release, delayed-release or potassium-salt products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、凸面、9 mm、无刻痕；无刻痕与缓释身份都不是网页提供的分片许可", "en": "round, convex, 9 mm and unscored; neither the unscored appearance nor the extended-release identity is web permission to split" }, "imprint": "ING / 278", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diclofenac-sodium-er-100mg-90-tablet-bottle-ndc-80425041403", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国仿制品标签（2024-07-16 发布；处方信息 2023-10 修订）", "en": "Current U.S. DailyMed generic label (published 16 Jul 2024; prescribing information revised Oct 2023)" }, "dosageForm": { "zh": "双氯芬酸钠 100 mg 缓释口服片（仿制品比较项）", "en": "diclofenac sodium 100 mg extended-release oral tablet (generic comparator)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80425-0414-03", "pouchCode": null, "applicationNumber": "ANDA 216275", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片双氯芬酸钠 100 mg；90 片瓶装", "en": "Diclofenac sodium 100 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Diclofenac+Sodium+ER+100mg+80425-0414-03.jpg&setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "双氯芬酸钠", "en": "diclofenac sodium" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数，也不是与普通片、延迟释放片或钾盐产品的换算值", "en": "labelled amount per tablet; not an individual tablet count or a conversion to immediate-release, delayed-release or potassium-salt products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、凸面、9 mm、无刻痕；无刻痕与缓释身份都不是网页提供的分片许可", "en": "round, convex, 9 mm and unscored; neither the unscored appearance nor the extended-release identity is web permission to split" }, "imprint": "ING / 278", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-diclofenac-sodium-er-100mg-30-tablet-bottle-ndc-80425041401", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Diclofenac+Sodium+ER+100mg+80425-0414-01.jpg&setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "alt": "双氯芬酸钠缓释片 100 mg、NDC 80425-0414-01、30 片瓶装的 DailyMed 官方仿制品标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前仿制品标签（2024-07-16 发布）", "presentation": "仿制品比较项：每片双氯芬酸钠 100 mg，粉红色圆形无刻痕片，ING／278，NDC 80425-0414-01，30 片瓶装。", "notice": "此图是当前仿制品比较项，不是历史 VOLTAREN-XR 原品牌包装；仅对应 30 片瓶，不代表 60/90 片瓶、延迟释放片、双氯芬酸钾普通片、外用凝胶或实时库存，也不用于鉴定真伪。", "source": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VOLTAREN-XR 说明书放大阅读：先分清盐、释放方式、每片 mg 与 NSAID 重复", "en": "VOLTAREN-XR enlarged label: separate salt, release design, mg per tablet and duplicate NSAIDs" }, "summary": { "zh": "100 mg 是每片双氯芬酸钠标示量，30/60/90/100 Tablets 是不同瓶装数量，不是个人每次片数。品牌缓释片、钠盐延迟释放片与钾盐普通片不是按相同 mg 自动等效的产品。", "en": "The 100 mg figure is labelled diclofenac sodium per tablet, while 30/60/90/100 Tablets are different bottle counts—not an individual tablet count. Brand extended-release, sodium delayed-release and potassium immediate-release tablets are not automatically equivalent at the same milligram number." }, "checks": [ { "zh": "当前仿制品为粉红色圆形无刻痕缓释片。无刻痕和缓释字样都不是网页允许切开、压碎、磨粉或用半片替代另一规格的许可；须核对手中准确产品、处方和现行说明书。", "en": "The current generic comparator is a pink, round, unscored extended-release tablet. Neither the unscored appearance nor the extended-release wording is web permission to cut, crush, powder or replace another strength with half a tablet; check the exact product, prescription and current label in hand." }, { "zh": "不要与 NAPROSYN、ALEVE、ADVIL、MOBIC、CELEBREX、ARCOXIA、阿司匹林止痛剂量或其他 NSAID 自行叠加。不同商品名可能仍属于同类风险，网页不生成错开时间或替换方案。", "en": "Do not self-combine it with NAPROSYN, ALEVE, ADVIL, MOBIC, CELEBREX, ARCOXIA, analgesic-dose aspirin or another NSAID. Different brand names may still share class risks; the site does not generate separation or substitution plans." }, { "zh": "老人、既往溃疡或出血、心血管病、心衰、水肿、肝肾功能异常者，以及同时使用抗凝/抗血小板药、激素、SSRI/SNRI、ACEI/ARB、利尿剂、锂、甲氨蝶呤或环孢素者，应优先交由药师或临床团队核对。", "en": "Older adults; people with prior ulcer or bleeding, cardiovascular disease, heart failure, oedema, hepatic or renal impairment; and those co-using anticoagulant/antiplatelet medicines, corticosteroids, an SSRI/SNRI, ACE inhibitor/ARB, diuretic, lithium, methotrexate or ciclosporin require priority pharmacist or clinical review." }, { "zh": "胸痛、单侧无力或言语含糊、呼吸困难、面喉肿胀、呕血、黑便、严重皮疹伴发热或其他严重急性表现，应立即使用当地急救服务并带上全部药盒。", "en": "Chest pain, one-sided weakness or slurred speech, breathing difficulty, face/throat swelling, vomiting blood, black stool, severe rash with fever or another severe acute feature requires immediate local emergency care; take every medicine pack." } ], "source": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "双氯芬酸怎样起作用：抑制 COX-1／COX-2，减少前列腺素形成", "en": "How diclofenac works: COX-1/COX-2 inhibition reduces prostaglandin formation" }, "summary": { "zh": "标签说明双氯芬酸通过抑制 COX-1 和 COX-2，减少前列腺素合成，从而产生镇痛、抗炎和解热作用。这个共同机制也解释了为什么胃肠道、心血管、肾脏、出血、水肿和 NSAID 重复需要一起核对，但不能从机制推导个人剂量或换药。", "en": "The label explains that diclofenac inhibits COX-1 and COX-2 and reduces prostaglandin synthesis, producing analgesic, anti-inflammatory and antipyretic effects. The shared mechanism also explains why gastrointestinal, cardiovascular, renal, bleeding, oedema and duplicate-NSAID risks require review, but it cannot determine an individual dose or switch." }, "checks": [ { "zh": "VOLTAREN-XR、VOLTAREN 延迟释放片和 CATAFLAM 双氯芬酸钾普通片共享双氯芬酸相关成分，却具有不同盐型或释放设计；标签明确即使 mg 相同也未必生物等效。", "en": "VOLTAREN-XR, VOLTAREN delayed-release tablets and CATAFLAM immediate-release diclofenac potassium share diclofenac-related ingredients but differ in salt or release design; the label says they are not necessarily bioequivalent even at the same milligram strength." }, { "zh": "外用 VOLTAREN Arthritis Pain 凝胶和滴眼用 VOLTAREN 也是不同途径产品，不能把外用百分比、口服 mg 或滴眼浓度放在同一换算表。", "en": "Topical VOLTAREN Arthritis Pain gel and ophthalmic VOLTAREN are different-route products; topical percentage, oral milligrams and ophthalmic concentration do not belong in one conversion table." }, { "zh": "药效机制不能回答个人‘应该吃几片’。若药盒、处方或药单同时出现多个止痛抗炎产品，应先暂停自行加药并让药师按准确成分、剂型和商品逐项核对。", "en": "Mechanism cannot answer how many tablets an individual should take. If several pain or anti-inflammatory products appear across packs, prescriptions or the medicine list, do not self-add another product; have a pharmacist review exact ingredients, dosage forms and brands." } ], "source": { "id": "src_676dec4d45e823d1", "label": "FDA：VOLTAREN-XR 双氯芬酸钠 100 mg 缓释片有日期品牌标签（2021-04 修订；历史标签，不代表当前品牌供应）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020254s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "VOLTAREN-XR", "generic": "双氯芬酸钠缓释片", "dosageFormClass": "双氯芬酸钠 100 mg 缓释口服片；VOLTAREN 双氯芬酸钠延迟释放片、CATAFLAM 双氯芬酸钾普通片、外用凝胶和滴眼液均为不同准确产品，标签明确不同口服剂型即使 mg 相同也未必生物等效" }, "labelSource": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_676dec4d45e823d1", "label": "FDA：VOLTAREN-XR 双氯芬酸钠 100 mg 缓释片有日期品牌标签（2021-04 修订；历史标签，不代表当前品牌供应）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020254s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：VOLTAREN、VOLTAREN-XR 与 CATAFLAM 历史 RLD 产品记录（2026-08-26 数据）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "VOLTAREN-XR 是双氯芬酸钠 100 mg 缓释片的美国历史品牌档案，目前 FDA 条目为 DISCN；页面同时展示当前仿制品三个准确瓶装面板。双氯芬酸钠延迟释放片、缓释片和双氯芬酸钾普通片即使数字相近，也不是可以按 mg 自行互换的同一产品。老人、多药使用者及同时使用阿司匹林、抗凝/抗血小板药、SSRI/SNRI、ACEI/ARB、利尿剂、锂、甲氨蝶呤或另一种 NSAID 者应优先核对完整药单。", "history": "FDA Orange Book 记录 VOLTAREN-XR NDA 020254 于 1996-03-08 获批；其 2021-04 标签修订加入心血管、胃肠道、胎儿肾功能、DRESS 等安全信息，FDA 同年批准 S-030。当前 Orange Book 将该品牌 RLD 列为 DISCN。DailyMed 2024-07 发布的 ANDA 216275 仿制品标签用于提供当前 100 mg 缓释剂型、三个瓶装身份及用药指南的比较阅读。", "sourceDocuments": [ { "id": "src_676dec4d45e823d1", "label": "FDA：VOLTAREN-XR 双氯芬酸钠 100 mg 缓释片有日期品牌标签（2021-04 修订；历史标签，不代表当前品牌供应）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020254s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_3666eabe612074da", "label": "FDA：VOLTAREN-XR NDA 020254／S-030 安全标签补充批准函（2021）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020254Orig1s030ltr.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": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：VOLTAREN、VOLTAREN-XR 与 CATAFLAM 历史 RLD 产品记录（2026-08-26 数据）", "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_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "VOLTAREN-XR NDA 020254（历史 RLD；当前 DISCN）；当前仿制品比较项 ANDA 216275", "approvalTimeline": [ { "date": "1996-03-08", "title": { "zh": "FDA 批准 VOLTAREN-XR 100 mg 缓释片", "en": "FDA approved VOLTAREN-XR 100 mg extended-release tablets" }, "detail": { "zh": "Orange Book 当前数据把 NDA 020254、100 mg、历史 RLD 和该日期相连；当前产品状态为 DISCN。", "en": "Current Orange Book data connect NDA 020254, 100 mg, historical RLD status and this date; the current product status is DISCN." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：VOLTAREN、VOLTAREN-XR 与 CATAFLAM 历史 RLD 产品记录（2026-08-26 数据）", "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" } }, { "date": "2021-04", "title": { "zh": "FDA 批准安全标签补充修订", "en": "FDA approved a supplemental safety-labelling revision" }, "detail": { "zh": "修订涉及胎儿肾功能、羊水过少、新生儿肾损害和 DRESS 等 NSAID 安全信息。", "en": "The revision addressed NSAID safety information including fetal renal dysfunction, oligohydramnios, neonatal renal impairment and DRESS." }, "source": { "id": "src_3666eabe612074da", "label": "FDA：VOLTAREN-XR NDA 020254／S-030 安全标签补充批准函（2021）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020254Orig1s030ltr.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": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2024-07-16", "title": { "zh": "当前仿制品 DailyMed 标签发布", "en": "Current generic DailyMed label published" }, "detail": { "zh": "标签列出 100 mg 缓释片、ING／278 外观及 30/60/90 片三个准确瓶装面板。", "en": "The label lists 100 mg extended-release tablets, the ING/278 appearance and exact 30/60/90-tablet bottle panels." }, "source": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "VOLTAREN-XR 历史 RLD 当前 DISCN；当前仿制品标签另列", "en": "Historical VOLTAREN-XR RLD currently DISCN; current generic label listed separately" }, "detail": { "zh": "历史品牌记录、当前仿制品在册和实际药房库存是不同证据层级。", "en": "Historical brand record, current generic listing and live pharmacy stock are separate evidence layers." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地批准、商品名、剂型、包装或供应", "en": "Local approval, brand, dosage form, package and supply are not established by this dossier" }, "detail": { "zh": "其他国家或地区须从当地药监机构与现行说明书逐项核对；美国历史品牌与当前美国仿制品资料不能外推为全球状态。", "en": "Check the local regulator and current local label market by market. Historical U.S. brand and current U.S. generic evidence must not be projected as worldwide status." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "VOLTAREN-XR 100 mg 和双氯芬酸钠延迟释放片 100 mg 一样吗？", "en": "Are VOLTAREN-XR 100 mg and 100 mg diclofenac sodium delayed-release tablets the same?" }, "answer": { "zh": "不能这样判断。缓释片、延迟释放片和普通片的释放设计不同，标签明确不同双氯芬酸口服剂型即使 mg 相同也未必生物等效；不要自行换算、拼片或替换。", "en": "No such conclusion follows. Extended-release, delayed-release and immediate-release tablets have different release designs, and the label states that different oral diclofenac formulations are not necessarily bioequivalent even at the same milligram strength. Do not self-convert, assemble tablets or substitute." } }, { "question": { "zh": "网页上的粉红色 ING／278 是原研 VOLTAREN-XR 吗？", "en": "Is the pink ING/278 tablet on this page originator VOLTAREN-XR?" }, "answer": { "zh": "不是。该图来自当前 ANDA 216275 仿制品标签；历史 VOLTAREN-XR 仅保留 FDA 标签文字身份，网页没有借用仿制品图片冒充原品牌。", "en": "No. The image comes from the current ANDA 216275 generic label. Historical VOLTAREN-XR retains only the FDA label's text identity; the site does not reuse a generic image as the originator brand." } }, { "question": { "zh": "已经用了布洛芬、萘普生、塞来昔布或阿司匹林，还能加双氯芬酸吗？", "en": "Can diclofenac be added if ibuprofen, naproxen, celecoxib or aspirin is already being used?" }, "answer": { "zh": "不要自行叠加。这些药可能共享 NSAID、出血、胃肠道、心血管或肾脏风险；请把所有处方药、OTC 止痛药、感冒复方和保健品交给药师按准确产品核对。", "en": "Do not self-combine them. These medicines may share NSAID, bleeding, gastrointestinal, cardiovascular or renal risks. Give all prescriptions, OTC pain medicines, cold 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" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/voltaren-xr-diclofenac/", "en": "https://origindrug.com/en/drugs/voltaren-xr-diclofenac/" }, "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." ] }