{ "id": "valium", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "VALIUM", "generic": "地西泮", "aliases": [ "VALIUM", "Valium", "diazepam", "diazepam tablets", "地西泮", "地西泮片", "安定", "NDA 013263", "80725-004-01", "80725-005-01", "80725-006-01", "VALIUM 2", "VALIUM 5", "VALIUM 10" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国当前公开标签：VALIUM 2 mg、5 mg、10 mg 三种 100 片瓶装；公开标签不等于目标市场批准、实时供应或购买资格", "dosageFormClass": "VALIUM 地西泮 C-IV 口服片：2 mg、5 mg、10 mg；各为 100 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1963-11-15（FDA Drugs@FDA 所列美国初始批准日期）", "archiveSponsorText": "Waylis Therapeutics LLC / FDA 与 DailyMed 当前公开监管记录" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "diazepam injection", "diazepam rectal gel", "diazepam nasal spray", "VALTOCO", "DIASTAT", "地西泮注射液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-valium-diazepam-tablet-2mg-100-bottle-ndc-8072500401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v11，2026-08-11 生效；标签修订 2024-08）", "en": "Current U.S. DailyMed label (SPL v11, effective 11 Aug 2026; label revised Aug 2024)" }, "dosageForm": { "zh": "VALIUM 地西泮口服片（C-IV）", "en": "VALIUM diazepam oral tablet (C-IV)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-004-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片地西泮 2 mg；100 片瓶装", "en": "Diazepam 2 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=valium-02.jpg&setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地西泮", "en": "diazepam" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰片、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、平面、带刻痕与 V 形穿孔、斜切边", "en": "round, flat-faced, scored with V-shaped perforation and beveled edges" }, "imprint": "2 / VALIUM", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 地西泮当前美国公开标签（Waylis；SPL v11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-valium-diazepam-tablet-5mg-100-bottle-ndc-8072500501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v11，2026-08-11 生效；标签修订 2024-08）", "en": "Current U.S. DailyMed label (SPL v11, effective 11 Aug 2026; label revised Aug 2024)" }, "dosageForm": { "zh": "VALIUM 地西泮口服片（C-IV）", "en": "VALIUM diazepam oral tablet (C-IV)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-005-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片地西泮 5 mg；100 片瓶装", "en": "Diazepam 5 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=valium-03.jpg&setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地西泮", "en": "diazepam" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰片、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、平面、带刻痕与 V 形穿孔、斜切边", "en": "round, flat-faced, scored with V-shaped perforation and beveled edges" }, "imprint": "5 / VALIUM", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 地西泮当前美国公开标签（Waylis；SPL v11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-valium-diazepam-tablet-10mg-100-bottle-ndc-8072500601", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v11，2026-08-11 生效；标签修订 2024-08）", "en": "Current U.S. DailyMed label (SPL v11, effective 11 Aug 2026; label revised Aug 2024)" }, "dosageForm": { "zh": "VALIUM 地西泮口服片（C-IV）", "en": "VALIUM diazepam oral tablet (C-IV)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-006-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片地西泮 10 mg；100 片瓶装", "en": "Diazepam 10 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=valium-04.jpg&setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地西泮", "en": "diazepam" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰片、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "圆形、平面、带刻痕与 V 形穿孔、斜切边", "en": "round, flat-faced, scored with V-shaped perforation and beveled edges" }, "imprint": "10 / VALIUM", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 地西泮当前美国公开标签（Waylis；SPL v11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-valium-diazepam-tablet-5mg-100-bottle-ndc-8072500501", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=valium-03.jpg&setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6&type=img", "alt": "VALIUM 地西泮 5 mg、NDC 80725-005-01、100 片瓶装在 DailyMed 当前标签中的展示图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v11；2026-08-11 生效；标签修订 2024-08", "presentation": "VALIUM 地西泮 5 mg、NDC 80725-005-01、100 片瓶装展示面", "notice": "图片只帮助核对这一准确美国标签产品的商品名、通用名、每片强度、NDC、瓶装数量与外观线索；不用于鉴定真伪，也不代表其他规格、其他地西泮剂型、其他市场、当前库存或任何个人用药方案。", "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 地西泮当前美国公开标签与包装图（SPL v11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VALIUM 说明书放大阅读：先防止镇静叠加与突然停用", "en": "VALIUM label reading: prevent additive sedation and abrupt withdrawal first" }, "summary": { "zh": "当前美国标签把阿片类合用、滥用/误用/成瘾、身体依赖与停药反应置于黑框警告。网页只整理核对点，不生成个人开始、加减量、分割或停药方案。", "en": "The current U.S. label places opioid co-use, abuse/misuse/addiction, physical dependence and withdrawal reactions in the boxed warning. This page organises checks; it does not generate an individual start, dose-change, split or stop plan." }, "checks": [ { "zh": "2、5、10 mg 是每片标示强度，100 Tablets 是整瓶片数。片剂的刻痕与 V 形穿孔是准确产品的识别线索，不是网页授权自行掰片、减量或替换。", "en": "The 2, 5 and 10 mg figures are labelled amounts per tablet; 100 Tablets is the bottle count. A score and V-shaped perforation identify an exact product; they are not website permission to split, taper or substitute." }, { "zh": "与阿片类药物合用可导致深度镇静、呼吸抑制、昏迷和死亡；酒精及其他中枢神经抑制药也可能叠加影响。请把处方药、非处方药、酒精使用与全部药盒交给药师或医生共同核对；出现呼吸困难、叫不醒等紧急表现应立即联系当地急救。", "en": "Co-use with opioids can cause profound sedation, respiratory depression, coma and death; alcohol and other CNS depressants may add effects. Have a pharmacist or clinician review prescriptions, OTC products, alcohol use and all packs together. Breathing difficulty or inability to awaken requires immediate local emergency help." }, { "zh": "持续使用可能形成身体依赖；突然停用或快速减量可引发危及生命的停药反应。不要自行骤停，也不要照搬网页或他人的减量表；应由负责治疗的专业人员根据实际情况制定并随访。", "en": "Continued use can produce physical dependence; abrupt discontinuation or rapid dose reduction can cause life-threatening withdrawal reactions. Do not abruptly stop or copy a web or another person's taper; the treating professional must individualise and follow it." }, { "zh": "老年人的消除半衰期可能延长并发生蓄积；嗜睡、共济失调、站立不稳、跌倒与骨折风险需优先核对。老人出现明显困倦、步态或意识变化、跌倒时，应避免驾驶并及时联系药师或医生核对完整药单，而不是自行停药。", "en": "Older adults may have a prolonged elimination half-life and accumulation. Somnolence, ataxia, unsteadiness, falls and fractures require priority review. Marked drowsiness, gait or awareness changes, or a fall requires avoiding driving and timely full-list review, not self-stopping." } ], "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 当前美国公开标签——黑框警告、老年人使用与药物相互作用", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用机制阅读：GABA 促进作用不能替代产品与风险核对", "en": "Mechanism reading: GABA facilitation does not replace product and risk checks" }, "summary": { "zh": "标签说明，苯二氮䓬类效应被认为来自对抑制性神经递质 GABA 的促进作用。这是机制解释，不是适应症、个人适用性或换药依据。", "en": "The label states that benzodiazepine effects are thought to arise from facilitation of the inhibitory neurotransmitter GABA. This explains a mechanism; it is not an indication, individual-suitability or switching rule." }, "checks": [ { "zh": "“促进 GABA”不能单独回答某个人是否需要 VALIUM、需要多少或用多久；这些问题必须回到准确诊断、处方、目标市场说明书和专业评估。", "en": "‘Facilitates GABA’ cannot decide whether an individual needs VALIUM, how much or for how long; those questions require the exact diagnosis, prescription, target-market label and professional assessment." }, { "zh": "阿片类与苯二氮䓬类通过不同系统抑制中枢活动，合用时呼吸抑制风险可相加；不能用“机制不同”推导安全同服。", "en": "Opioids and benzodiazepines depress central activity through different systems, and respiratory-depression risk can add; different mechanisms do not prove safe co-use." }, { "zh": "其他苯二氮䓬类药物即使也作用于 GABA-A 相关系统，也不能按商品名、颜色或 mg 与 VALIUM 一比一自行换算、叠加或轮换；网页不把机制说明扩展为常规基因筛查建议。", "en": "Other benzodiazepines may also involve GABA-A-related systems, but brand, colour or milligrams do not permit one-for-one self-conversion, combination or rotation with VALIUM. This mechanism text is not a routine genetic-screening recommendation." } ], "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 当前美国公开标签——临床药理 12.1 作用机制", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "VALIUM", "generic": "地西泮", "dosageFormClass": "VALIUM 地西泮 C-IV 口服片：2 mg、5 mg、10 mg；各为 100 片瓶装" }, "labelSource": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 地西泮当前美国公开标签（SPL v11；2026-08-11 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 地西泮当前美国公开标签（SPL v11；2026-08-11 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_27b3b9c1cb5996ad", "label": "FDA Drugs@FDA：VALIUM NDA 013263 产品与 RLD/RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=013263", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "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": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9a07aef31d58508f", "label": "FDA：VALIUM 2024 美国处方信息（NDA 013263）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/013263Orig1s101lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "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": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "VALIUM 是地西泮口服片的美国品牌监管档案。本页把 2 mg、5 mg、10 mg 三个当前公开标签产品分别绑定到准确 NDC、100 片瓶装、颜色、刻印和一手来源；包装数字、颜色、刻痕和共同的地西泮成分都不能转化为个人片数、掰片、减量、停用、联用或替换方案。", "history": "FDA Drugs@FDA 记录 NDA 013263 于 1963-11-15 首次批准。DailyMed 当前标签（SPL v11，2026-08-11 生效；标签修订 2024-08）由 Waylis Therapeutics LLC 发布，列示 2 mg 白色、5 mg 黄色、10 mg 蓝色圆形片和对应 100 片瓶装。FDA 的 RLD/RS 字段只描述美国监管参照关系；不能据此推定中国或其他国家当前批准、供应、真伪或可替代性。", "sourceDocuments": [ { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 地西泮当前美国公开标签（SPL v11；2026-08-11 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_27b3b9c1cb5996ad", "label": "FDA Drugs@FDA：VALIUM NDA 013263 产品与 RLD/RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=013263", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_9a07aef31d58508f", "label": "FDA：VALIUM 2024 美国处方信息（NDA 013263）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/013263Orig1s101lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "FDA NDA 013263（VALIUM；diazepam tablets）", "approvalTimeline": [ { "date": "1963-11-15", "title": { "zh": "FDA 首次批准 VALIUM NDA 013263", "en": "FDA first approved VALIUM NDA 013263" }, "detail": { "zh": "Drugs@FDA 产品记录将 VALIUM、地西泮口服片与该美国初始批准日期相连；这是美国监管历史节点，不代表其他市场批准或今天的供应。", "en": "The Drugs@FDA product record links VALIUM diazepam oral tablets to this initial U.S. approval date. It is a U.S. regulatory-history node, not evidence of another market's approval or today's supply." }, "source": { "id": "src_27b3b9c1cb5996ad", "label": "FDA Drugs@FDA：VALIUM NDA 013263 产品记录与初始批准日期", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=013263", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2026-08-11", "title": { "zh": "当前 DailyMed SPL v11 生效", "en": "Current DailyMed SPL v11 became effective" }, "detail": { "zh": "本页三种准确 100 片瓶装、外观、黑框警告和老年人阅读均以该当前公开标签为主要来源；标签日期不等于渠道库存。", "en": "The three exact 100-tablet bottles, appearance, boxed warning and older-adult reading on this page use this current public label as the primary source. A label date is not channel stock." }, "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 当前美国公开标签（SPL v11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "NDA 013263 当前公开产品记录与标签已建立", "en": "Current public product record and label established under NDA 013263" }, "detail": { "zh": "2 mg、5 mg、10 mg 均为 RLD；10 mg 另列为 RS。本页分别保存三种 NDC、100 片瓶装与标签图，但不声明任何渠道库存、真伪或个人适用性。", "en": "The 2 mg, 5 mg and 10 mg products are listed as RLDs; 10 mg is also listed as RS. The page preserves each NDC, 100-tablet bottle and label image, but does not claim channel stock, authenticity or individual suitability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "现行品牌、批准、包装和参比关系待逐市场核验", "en": "Current brand, approval, pack and reference status not yet established market by market" }, "detail": { "zh": "不从美国 VALIUM 商品名、NDA、RLD/RS、NDC、颜色或刻痕推定当地批准、供应、原研/参比关系、可售资格或可替代性。", "en": "No local approval, supply, originator/reference status, sale eligibility or interchangeability is inferred from the U.S. VALIUM name, NDA, RLD/RS status, NDC, colour or score." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "药片有刻痕，能自己掰开或减量吗？", "en": "Can a scored tablet be split or reduced without review?" }, "answer": { "zh": "不能从刻痕直接得出结论。刻痕和 V 形穿孔首先是这一准确产品的身份线索；是否可分割、怎样减量或停用必须由负责治疗的专业人员结合实际处方和包装确认。", "en": "A score does not decide this. The score and V-shaped perforation first identify the exact product. A treating professional must use the actual prescription and pack to decide whether it can be divided and how any reduction or stop is handled." } }, { "question": { "zh": "和止痛药或酒一起用安全吗？", "en": "Is it safe with a pain medicine or alcohol?" }, "answer": { "zh": "网页不能给个人联用结论。阿片类止痛药可与 VALIUM 叠加深度镇静和呼吸抑制；酒精及其他中枢抑制药也需一并核对。请把完整药单和酒精使用情况交给药师或医生。", "en": "A webpage cannot decide individual co-use. Opioid pain medicines can add profound sedation and respiratory depression with VALIUM, and alcohol and other CNS depressants also require review. Give the full list and alcohol use to a pharmacist or clinician." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/valium/", "en": "https://origindrug.com/en/drugs/valium/" }, "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." ] }