{ "id": "depakote", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "DEPAKOTE", "generic": "双丙戊酸钠延迟释放片", "aliases": [ "Depakote", "双丙戊酸钠延迟释放片", "双丙戊酸钠肠溶片", "divalproex sodium delayed-release tablets", "divalproex sodium", "divalproex sodium delayed release", "双丙戊酸钠", "NDA 018723", "0074-7325-13", "0074-7326-13", "0074-7327-13" ], "marketBrandNames": [ { "name": "DEPAKOTE", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 018723；125/250/500 mg 均为处方 RLD，500 mg 同时为 RS；当前标签展示三个准确 100 片瓶装面板。", "en": "NDA 018723; 125/250/500 mg are prescription RLD products and 500 mg is also the RS; the current label displays three exact 100-tablet bottle panels." }, "source": { "id": "src_10f9fa31428b78fd", "label": "FDA Drugs@FDA：DEPAKOTE NDA 018723 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018723", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国：DailyMed 当前 NDA 品牌标签列 DEPAKOTE 125、250、500 mg 延迟释放片及三个准确 100 片瓶装面板。FDA Orange Book 将三个规格列为处方 RLD，并将 500 mg 列为 RS。公开标签和 RLD 状态不证明实时库存、个人适用性、个人剂量，亦不证明与 DEPAKOTE ER、Sprinkle 胶囊、丙戊酸胶囊或其他丙戊酸盐可直接互换。", "dosageFormClass": "双丙戊酸钠延迟释放片：每片以丙戊酸活性计 125、250 或 500 mg；必须整片吞服，不得压碎或咀嚼；不是 DEPAKOTE ER 缓释片，也不是 DEPAKOTE Sprinkle 延迟释放胶囊", "dosageFormClassCode": "oral_modified_release", "route": "口服（高风险延迟释放片准确产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "1983-03-10（250/500 mg）；1984-10-26（125 mg）", "archiveSponsorText": "AbbVie Inc.（DailyMed 当前标签与 FDA Orange Book 当前申请主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "DEPAKOTE ER", "DEPAKOTE Sprinkle", "divalproex sodium extended-release tablets", "divalproex sodium delayed-release capsules", "valproic acid capsules", "sodium valproate injection" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-depakote-divalproex-sodium-delayed-release-125mg-100-tablet-bottle-ndc-0074732513", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 NDA 品牌标签（2026-03-31 更新）", "en": "Current U.S. DailyMed NDA brand label (updated 31 Mar 2026)" }, "dosageForm": { "zh": "DEPAKOTE 双丙戊酸钠延迟释放口服片", "en": "DEPAKOTE divalproex sodium delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片产品身份字段）", "en": "oral (intact delayed-release tablet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-7325-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于丙戊酸 125 mg；100 片瓶装", "en": "Equivalent to valproic acid 125 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=depakote-tablets-spl-07.jpg&setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "双丙戊酸钠（以丙戊酸活性计）", "en": "divalproex sodium (as valproic acid activity)" }, "value": 125, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、频次、疗程、换药或血药浓度换算", "en": "label strength per tablet; not an individual's tablet count, frequency, course, switch or plasma-level conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片处方药瓶装标签展示面", "en": "100-tablet prescription bottle label panel" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "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": "鲑粉色", "en": "salmon pink" }, "shape": { "zh": "椭圆形、无刻痕延迟释放片", "en": "oval, unscored delayed-release tablet" }, "imprint": "NT", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-depakote-divalproex-sodium-delayed-release-250mg-100-tablet-bottle-ndc-0074732613", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 NDA 品牌标签（2026-03-31 更新）", "en": "Current U.S. DailyMed NDA brand label (updated 31 Mar 2026)" }, "dosageForm": { "zh": "DEPAKOTE 双丙戊酸钠延迟释放口服片", "en": "DEPAKOTE divalproex sodium delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片产品身份字段）", "en": "oral (intact delayed-release tablet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-7326-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于丙戊酸 250 mg；100 片瓶装", "en": "Equivalent to valproic acid 250 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=depakote-tablets-spl-0c.jpg&setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "双丙戊酸钠（以丙戊酸活性计）", "en": "divalproex sodium (as valproic acid activity)" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、频次、疗程、换药或血药浓度换算", "en": "label strength per tablet; not an individual's tablet count, frequency, course, switch or plasma-level conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片处方药瓶装标签展示面", "en": "100-tablet prescription bottle label panel" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "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": "桃色", "en": "peach" }, "shape": { "zh": "椭圆形、无刻痕延迟释放片", "en": "oval, unscored delayed-release tablet" }, "imprint": "NR", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-depakote-divalproex-sodium-delayed-release-500mg-100-tablet-bottle-ndc-0074732713", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 NDA 品牌标签（2026-03-31 更新）", "en": "Current U.S. DailyMed NDA brand label (updated 31 Mar 2026)" }, "dosageForm": { "zh": "DEPAKOTE 双丙戊酸钠延迟释放口服片", "en": "DEPAKOTE divalproex sodium delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片产品身份字段）", "en": "oral (intact delayed-release tablet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-7327-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于丙戊酸 500 mg；100 片瓶装", "en": "Equivalent to valproic acid 500 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=depakote-tablets-spl-0b.jpg&setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "双丙戊酸钠（以丙戊酸活性计）", "en": "divalproex sodium (as valproic acid activity)" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、频次、疗程、换药或血药浓度换算", "en": "label strength per tablet; not an individual's tablet count, frequency, course, switch or plasma-level conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片处方药瓶装标签展示面", "en": "100-tablet prescription bottle label panel" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "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": "淡紫色", "en": "lavender" }, "shape": { "zh": "椭圆形、无刻痕延迟释放片", "en": "oval, unscored delayed-release tablet" }, "imprint": "NS", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-depakote-divalproex-sodium-delayed-release-125mg-100-tablet-bottle-ndc-0074732513", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=depakote-tablets-spl-07.jpg&setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "alt": "DEPAKOTE 125 mg、100 片、NDC 0074-7325-13 的美国 DailyMed 当前包装标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前标签；2026-03-31 更新", "presentation": "DEPAKOTE 双丙戊酸钠延迟释放片，每片相当于丙戊酸 125 mg，100 片瓶装，NDC 0074-7325-13。", "notice": "此图只对应所引美国当前标签中的 125 mg、100 片瓶装；不代表 250/500 mg、DEPAKOTE ER、Sprinkle 胶囊、其他丙戊酸产品、其他市场或实时库存。它不用于鉴定真伪，也不生成个人片数、频率、换药或漏服方案。", "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DEPAKOTE 说明书放大阅读：相同 mg 不等于相同剂型", "en": "DEPAKOTE label reading: the same mg does not mean the same dosage form" }, "summary": { "zh": "本页只对应延迟释放片。125、250 和 500 mg 都是每片以丙戊酸活性计的标签强度；三种片剂均需整片吞服，不得压碎或咀嚼。DEPAKOTE ER 是另一种缓释片，Sprinkle 是可撒服的延迟释放胶囊，不能把它们的说明套到本页产品。", "en": "This page covers delayed-release tablets only. The 125, 250 and 500 mg figures are label strengths per tablet expressed as valproic acid activity; all three tablets must be swallowed whole and not crushed or chewed. DEPAKOTE ER is a different extended-release tablet and Sprinkle is a delayed-release capsule that may be sprinkled, so their instructions must not be transferred to this product." }, "checks": [ { "zh": "mg 是每片强度，不是一天总量、血药浓度或片数。药盒同样写 500 mg，也不能据此把 DEPAKOTE 延迟释放片与 DEPAKOTE ER 缓释片一比一自行替换；任何剂型或联用变化都应结合临床状态与丙戊酸血药浓度监测。", "en": "The mg figure is strength per tablet, not a daily total, plasma concentration or tablet count. A shared 500 mg label does not permit one-for-one self-substitution between DEPAKOTE delayed-release and DEPAKOTE ER extended-release tablets; any formulation or co-medication change requires clinical and valproate-level review." }, { "zh": "DEPAKOTE 延迟释放片无刻痕，标签要求整片吞服，不能为‘吃一半’而压碎、咀嚼或自行掰分。吞咽困难应先核对准确处方和剂型；不能擅自改用 Sprinkle、ER 或液体。", "en": "DEPAKOTE delayed-release tablets are unscored and the label says to swallow whole. Do not crush, chew or divide one to make ‘half’. A swallowing difficulty requires review of the exact prescription and dosage form, not an unreviewed switch to Sprinkle, ER or a liquid." }, { "zh": "黑框警告包括可能致命的肝毒性、胎儿风险和胰腺炎。持续或剧烈腹痛伴恶心呕吐、明显黄疸或异常乏力、意识改变等需要及时医疗评估；网页不等待症状自行消失。", "en": "The boxed warning includes potentially fatal hepatotoxicity, fetal risk and pancreatitis. Persistent or severe abdominal pain with nausea or vomiting, marked jaundice or unusual fatigue, or altered awareness needs timely medical assessment; the site does not wait for symptoms to resolve." }, { "zh": "老人对嗜睡可能更敏感，且游离药物比例可能更高。出现过度嗜睡、进食或饮水减少、脱水、跌倒、步态或意识变化时，应尽快联系专业人员并带上完整药单，不要自行停药或骤减。", "en": "Older adults may be more sensitive to somnolence and may have a higher unbound drug fraction. Excessive sleepiness, reduced food or fluid intake, dehydration, falls, gait or awareness changes require prompt professional review with the complete medicine list; do not stop or sharply reduce treatment yourself." }, { "zh": "碳青霉烯类抗菌药可能显著降低丙戊酸浓度；托吡酯同用与高氨血症/脑病相关；拉莫三嗪、阿司匹林及抗凝或抗血小板药也需要逐项核对。网页不建议靠错开时间自行解决。", "en": "Carbapenem antibiotics may markedly reduce valproate concentrations; concomitant topiramate is associated with hyperammonaemia/encephalopathy; lamotrigine, aspirin, anticoagulants and antiplatelets also require item-by-item review. The site does not advise solving these interactions by self-separating times." }, { "zh": "妊娠或可能妊娠涉及重大胎儿风险，但用于癫痫时突然停用也可能引发持续状态。应立即通过开方团队或当地医疗服务获得个体化评估；网页不替代避孕、孕前或孕期专科咨询，也不指示突然停药。", "en": "Pregnancy or possible pregnancy carries major fetal risk, while abrupt withdrawal in epilepsy may precipitate status epilepticus. Obtain individual review promptly through the prescribing team or local medical service; the site does not replace contraception, preconception or pregnancy specialist counselling and does not direct abrupt withdrawal." } ], "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "双丙戊酸钠怎样起作用：影响神经兴奋性，不是用症状直接换算片数", "en": "How divalproex works: changing neuronal excitability does not convert symptoms into tablets" }, "summary": { "zh": "双丙戊酸钠在胃肠道中解离为丙戊酸离子。其抗癫痫作用机制尚未完全确定，通常认为与提高脑内抑制性神经递质 GABA 水平有关。蛋白结合、年龄、肝肾状态及其他药物会影响总浓度与游离药物，因此同一个化验数字也不能由网页直接换成个人片数。", "en": "Divalproex sodium dissociates to valproate ion in the gastrointestinal tract. Its antiepileptic mechanism is not fully established and is commonly thought to relate to increased brain concentrations of the inhibitory neurotransmitter GABA. Protein binding, age, liver or kidney status and other medicines affect total and unbound drug, so a laboratory number cannot be converted by this site into an individual's tablet count." }, "checks": [ { "zh": "延迟释放、缓释和胶囊撒服描述释放结构与使用方式，不等同于‘更强’或‘更弱’。不能仅按总毫克数自行轮换、叠加或替换。", "en": "Delayed release, extended release and sprinkle capsules describe release structure and use, not ‘stronger’ or ‘weaker’. Total milligrams alone do not permit self-alternation, combination or substitution." }, { "zh": "血药浓度通常需要与临床状态、采血时间、白蛋白、肝肾功能、血细胞和完整药单一起解释；老人或低白蛋白状态下总浓度可能低估游离药物。", "en": "A plasma concentration is interpreted with clinical status, sampling time, albumin, liver and kidney function, blood counts and the complete medicine list; in older adults or low-albumin states, total concentration may understate unbound drug." }, { "zh": "并非每个人都需要全基因筛查；但现行标签明确把已知 POLG 相关线粒体病列为重要禁忌，并提示特定病史时评估尿素循环障碍。是否检测由专业团队根据年龄、病史、症状和用途决定。", "en": "Not everyone needs whole-genome screening. Current labelling identifies known POLG-related mitochondrial disease as an important contraindication and advises assessment for urea-cycle disorders in selected histories. Testing decisions belong to the clinical team based on age, history, symptoms and indication." } ], "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DEPAKOTE", "generic": "双丙戊酸钠延迟释放片", "dosageFormClass": "双丙戊酸钠延迟释放片：每片以丙戊酸活性计 125、250 或 500 mg；必须整片吞服，不得压碎或咀嚼；不是 DEPAKOTE ER 缓释片，也不是 DEPAKOTE Sprinkle 延迟释放胶囊" }, "labelSource": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10f9fa31428b78fd", "label": "FDA Drugs@FDA：DEPAKOTE NDA 018723 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018723", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_190da96627768ce2", "label": "DailyMed（NLM）：DEPAKOTE ER 双丙戊酸钠缓释片当前美国标签（用于严格区分剂型）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a7ec88a-3379-4376-b49a-f60ae8b09fd0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_fe82ece6945b8032", "label": "DailyMed（NLM）：DEPAKOTE Sprinkle 双丙戊酸钠延迟释放胶囊当前美国标签（用于严格区分剂型）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4619aff4-0f80-444f-858d-42e4137aa809", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DEPAKOTE 是双丙戊酸钠延迟释放片，药盒上的 125、250 或 500 mg 指每片以丙戊酸活性计的强度，不是一天总量，也不能用相同 mg 自行替换 DEPAKOTE ER 或 Sprinkle 胶囊。三种片剂都要整片吞服，不得压碎或咀嚼。老人出现明显嗜睡、进食饮水减少、步态或意识变化时，需要结合完整药单、肝功能、血细胞、血氨和血药浓度等由专业人员评估，不能自行停药或减半。", "history": "FDA Orange Book 记录 DEPAKOTE 250/500 mg 延迟释放片于 1983-03-10 获批，125 mg 于 1984-10-26 获批。DailyMed 当前标签于 2026-03-31 更新，展示三个准确 100 片瓶装面板，并保留肝毒性、胎儿风险和胰腺炎黑框警告。页面把准确产品、剂型、包装、历史和安全边界分开。", "sourceDocuments": [ { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10f9fa31428b78fd", "label": "FDA Drugs@FDA：DEPAKOTE NDA 018723 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018723", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_190da96627768ce2", "label": "DailyMed（NLM）：DEPAKOTE ER 双丙戊酸钠缓释片当前美国标签（用于严格区分剂型）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a7ec88a-3379-4376-b49a-f60ae8b09fd0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_fe82ece6945b8032", "label": "DailyMed（NLM）：DEPAKOTE Sprinkle 双丙戊酸钠延迟释放胶囊当前美国标签（用于严格区分剂型）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4619aff4-0f80-444f-858d-42e4137aa809", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 018723（DEPAKOTE divalproex sodium delayed-release tablets）", "approvalTimeline": [ { "date": "1983-03-10", "title": { "zh": "FDA 批准 DEPAKOTE 250/500 mg", "en": "FDA approved DEPAKOTE 250/500 mg" }, "detail": { "zh": "当前 Orange Book 将两个规格列为 RLD，并将 500 mg 列为 RS。", "en": "The current Orange Book lists both strengths as RLD products and 500 mg as the RS." }, "source": { "id": "src_10f9fa31428b78fd", "label": "FDA Drugs@FDA：DEPAKOTE NDA 018723 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018723", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1984-10-26", "title": { "zh": "FDA 批准 DEPAKOTE 125 mg", "en": "FDA approved DEPAKOTE 125 mg" }, "detail": { "zh": "当前 Orange Book 将 125 mg 延迟释放片列为 RLD。", "en": "The current Orange Book lists the 125 mg delayed-release tablet as an RLD." }, "source": { "id": "src_10f9fa31428b78fd", "label": "FDA Drugs@FDA：DEPAKOTE NDA 018723 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018723", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-03-31", "title": { "zh": "DailyMed 当前标签更新", "en": "Current DailyMed label updated" }, "detail": { "zh": "当前记录展示三个准确瓶装面板、Medication Guide、黑框警告、整片吞服与老年嗜睡等边界。", "en": "The current record displays three exact bottle panels, the Medication Guide, boxed warnings, whole-tablet handling and older-adult somnolence boundaries." }, "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前处方 RLD 延迟释放片；500 mg 为 RS", "en": "Current prescription RLD delayed-release tablets; 500 mg is RS" }, "detail": { "zh": "三个 100 片瓶装面板已逐项建立。监管与包装记录不证明实时库存、购买资格、个人适用性或与其他丙戊酸制剂可替代。", "en": "Three 100-tablet bottle panels are recorded individually. Regulatory and package records do not establish real-time stock, purchasing eligibility, individual suitability or interchangeability with another valproate formulation." } }, { "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": "待逐项建立现行市场记录", "en": "Current market records not established" }, "detail": { "zh": "不从美国品牌名、相同成分或 mg 数字推定当地批准、剂型、供应、原研/仿制关系或可替代性。", "en": "No local approval, dosage form, supply, originator/generic relationship or interchangeability is inferred from a U.S. brand name, shared ingredient or mg figure." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "500 mg 的 DEPAKOTE 和 500 mg 的 DEPAKOTE ER 是一回事吗？", "en": "Are DEPAKOTE 500 mg and DEPAKOTE ER 500 mg the same?" }, "answer": { "zh": "不是同一剂型。本页是延迟释放片，ER 是另一种缓释片；相同 mg 只说明标签强度相同，不能证明释放曲线、使用频次或替换方式相同。不要自行一比一换药。", "en": "They are not the same dosage form. This page covers delayed-release tablets; ER is a different extended-release tablet. A shared mg strength does not establish the same release profile, frequency or switching method. Do not make a one-for-one switch yourself." } }, { "question": { "zh": "药片太大，可以掰一半或碾碎吗？", "en": "The tablet is large. Can it be halved or crushed?" }, "answer": { "zh": "本页三个 DEPAKOTE 延迟释放片均无刻痕，当前标签要求整片吞服，不得压碎或咀嚼。吞咽困难应让药师或开方团队核对准确处方与其他合适剂型，不能自行改成 Sprinkle 或 ER。", "en": "All three DEPAKOTE delayed-release tablets on this page are unscored, and the current label says to swallow whole and not crush or chew. A swallowing difficulty requires review of the exact prescription and a suitable formulation by a pharmacist or prescriber, not a self-switch to Sprinkle or ER." } }, { "question": { "zh": "为什么不是人人都做全基因筛查？", "en": "Why is whole-genome screening not routine for everyone?" }, "answer": { "zh": "标签关注的是特定高风险线索，例如已知 POLG 相关线粒体病和提示尿素循环障碍的病史；这不等于所有使用者都需要全基因筛查。检测范围应由专业团队依据年龄、病史、用途和症状决定。", "en": "The label focuses on specific high-risk clues such as known POLG-related mitochondrial disease and histories suggestive of a urea-cycle disorder. That does not mean every user needs whole-genome screening. The clinical team determines testing from age, history, indication and symptoms." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-units-and-concentrations", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/depakote/", "en": "https://origindrug.com/en/drugs/depakote/" }, "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." ] }