{ "id": "buspar-buspirone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-09", "status": "published_traceable_archive" }, "names": { "brand": "BuSpar", "generic": "盐酸丁螺环酮", "aliases": [ "BUSPAR", "BuSpar", "buspirone", "buspirone hydrochloride", "丁螺环酮", "盐酸丁螺环酮片", "盐酸丁螺环酮" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国：BuSpar 历史品牌 NDA 018731；当前仿制品标签单独列示，其他市场待核验。", "dosageFormClass": "口服固体制剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1986-09-29", "archiveSponsorText": "BRISTOL MYERS SQUIBB (historical FDA application)" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "BuSpar", "buspirone", "buspirone hydrochloride", "丁螺环酮", "盐酸丁螺环酮" ], "excludedProductCues": [ "bupropion", "安非他酮", "alprazolam", "阿普唑仑" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-buspar-5mg-100-tablet-historical-ndc-0087081841", "marketCode": "US", "labelVersion": { "zh": "FDA 2010-11 历史品牌标签，第 19 页", "en": "Historical FDA brand label, Nov 2010, page 19" }, "dosageForm": { "zh": "盐酸丁螺环酮口服片（历史品牌）", "en": "Buspirone hydrochloride oral tablets (historical brand)" }, "route": { "zh": "口服（历史产品身份字段）", "en": "Oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-0818-41", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸丁螺环酮 5 mg；100 片/瓶（2010 历史记录）", "en": "5 mg buspirone hydrochloride per tablet; 100 tablets/bottle (2010 historical record)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸丁螺环酮", "en": "buspirone hydrochloride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量，不是个人片数", "en": "Labelled amount per tablet, not an individual tablet count" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-buspar-10mg-100-tablet-historical-ndc-0087081941", "marketCode": "US", "labelVersion": { "zh": "FDA 2010-11 历史品牌标签，第 19 页", "en": "Historical FDA brand label, Nov 2010, page 19" }, "dosageForm": { "zh": "盐酸丁螺环酮口服片（历史品牌）", "en": "Buspirone hydrochloride oral tablets (historical brand)" }, "route": { "zh": "口服（历史产品身份字段）", "en": "Oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-0819-41", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸丁螺环酮 10 mg；100 片/瓶（2010 历史记录）", "en": "10 mg buspirone hydrochloride per tablet; 100 tablets/bottle (2010 historical record)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸丁螺环酮", "en": "buspirone hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量，不是个人片数", "en": "Labelled amount per tablet, not an individual tablet count" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-buspar-15mg-60-tablet-historical-ndc-0087082232", "marketCode": "US", "labelVersion": { "zh": "FDA 2010-11 历史品牌标签，第 19 页", "en": "Historical FDA brand label, Nov 2010, page 19" }, "dosageForm": { "zh": "盐酸丁螺环酮口服片（历史品牌）", "en": "Buspirone hydrochloride oral tablets (historical brand)" }, "route": { "zh": "口服（历史产品身份字段）", "en": "Oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-0822-32", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸丁螺环酮 15 mg；60 片/瓶（2010 历史记录）", "en": "15 mg buspirone hydrochloride per tablet; 60 tablets/bottle (2010 historical record)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸丁螺环酮", "en": "buspirone hydrochloride" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量，不是个人片数", "en": "Labelled amount per tablet, not an individual tablet count" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-buspar-15mg-180-tablet-historical-ndc-0087082233", "marketCode": "US", "labelVersion": { "zh": "FDA 2010-11 历史品牌标签，第 19 页", "en": "Historical FDA brand label, Nov 2010, page 19" }, "dosageForm": { "zh": "盐酸丁螺环酮口服片（历史品牌）", "en": "Buspirone hydrochloride oral tablets (historical brand)" }, "route": { "zh": "口服（历史产品身份字段）", "en": "Oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-0822-33", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸丁螺环酮 15 mg；180 片/瓶（2010 历史记录）", "en": "15 mg buspirone hydrochloride per tablet; 180 tablets/bottle (2010 historical record)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸丁螺环酮", "en": "buspirone hydrochloride" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量，不是个人片数", "en": "Labelled amount per tablet, not an individual tablet count" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 180, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-buspar-30mg-60-tablet-historical-ndc-0087082481", "marketCode": "US", "labelVersion": { "zh": "FDA 2010-11 历史品牌标签，第 19 页", "en": "Historical FDA brand label, Nov 2010, page 19" }, "dosageForm": { "zh": "盐酸丁螺环酮口服片（历史品牌）", "en": "Buspirone hydrochloride oral tablets (historical brand)" }, "route": { "zh": "口服（历史产品身份字段）", "en": "Oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-0824-81", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸丁螺环酮 30 mg；60 片/瓶（2010 历史记录）", "en": "30 mg buspirone hydrochloride per tablet; 60 tablets/bottle (2010 historical record)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸丁螺环酮", "en": "buspirone hydrochloride" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量，不是个人片数", "en": "Labelled amount per tablet, not an individual tablet count" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "目前仅列历史标签文字，未展示原品牌包装图", "en": "Historical label text only; no verified originator pack image" }, "summary": { "zh": "未完成原品牌包装及分片图示的目视核验。DailyMed 另有 Rising Pharma 通用药包装，不能用来冒充 BuSpar；颜色、刻印相似也不能证明真伪。", "en": "Originator packaging and splitting diagrams have not completed visual review. Rising Pharma generic panels must not stand in for BuSpar; similar appearance cannot authenticate a product." }, "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "丁螺环酮说明书大字阅读：先核对完整药单", "en": "Buspirone label reading: start with the whole medicine list" }, "summary": { "zh": "以下安全阅读依据 Rising Pharma 通用药标签，不把它写成 BuSpar 原品牌新说明书。历史品牌 PDF 另列于来源中。阅读时先看准确厂牌、规格和标签日期，再与药师讨论个人用药。", "en": "These safety notes use the distinct Rising Pharma generic label, not an updated BuSpar brand label. The historical brand PDF is listed separately. Check the actual manufacturer, strength and label date with a pharmacist." }, "checks": [ { "zh": "把抗抑郁药、曲普坦类和利奈唑胺等完整列入药单。标签列出 MAOI 联用禁忌及血清素综合征警示，停换及间隔由医疗团队安排。", "en": "Include antidepressants, triptans and linezolid in the medicine list. MAOI contraindications and serotonin-syndrome warnings require clinician-managed treatment changes." }, { "zh": "明显意识改变、高热、肌肉僵硬或抽搐，应及时求助当地急救；网页不能判断是否为血清素综合征。", "en": "Severe confusion, high fever, rigidity or seizures require urgent medical help; a webpage cannot diagnose serotonin syndrome." }, { "zh": "老人中部分人可能更敏感；头晕、站立不稳或嗜睡时注意跌倒和驾驶风险，并联系医疗团队。严重肝肾损害须专业核对。", "en": "Some older adults may be more sensitive. Dizziness, unsteadiness or drowsiness warrants fall/driving precautions and clinical review; severe liver or kidney impairment needs professional assessment." }, { "zh": "药盒的 mg 是每片含量，60 Tablets 是整瓶 60 片。若有不同数字或刻痕，先看手中产品说明书，不从网页自行计算吃几片或掰几份。", "en": "Mg describes strength per tablet; 60 Tablets is the bottle count. Check the actual label before interpreting scores or different figures; do not calculate a personal regimen here." } ], "source": { "id": "src_e536090c802955f0", "label": "DailyMed: Rising Pharma buspirone hydrochloride generic tablets; page updated 2026-03-02, printed issue 02/2025; not BuSpar packaging", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b9aa144c-cb36-4069-9eaa-7c150298cdd7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "它与常见镇静药有什么不同？", "en": "How does it differ from common sedatives?" }, "summary": { "zh": "2010 年品牌标签指出：确切作用机制尚不明确，体外研究显示对 5-HT1A 受体有较高亲和力；不能把受体名称当成个人疗效预测。", "en": "The historical label says the exact mechanism is unknown and describes high in-vitro affinity for 5-HT1A receptors. Receptor findings do not predict an individual response." }, "checks": [ { "zh": "作用不同：历史标签不把丁螺环酮列为苯二氮䓬类，也不把它作为抗惊厥或肌肉松弛药。用途相近不等于同一种药。", "en": "Different action: the historical label distinguishes buspirone from benzodiazepines and does not attribute anticonvulsant or muscle-relaxant effects to it. A similar use does not mean the same medicine." }, { "zh": "换药前要核对：丁螺环酮不能阻止苯二氮䓬类停药后的戒断反应；不要以它为理由骤停原有镇静或助眠药。", "en": "Before a switch: buspirone does not prevent benzodiazepine withdrawal; do not abruptly stop an existing sedative or sleeping medicine because of it." }, { "zh": "吃饭前后要一致：食物会影响吸收。历史标签要求固定随餐或固定不随餐服用；拿实际产品的当前说明书请药师核对，不要随意交替。", "en": "Keep the food pattern consistent: food affects absorption. The historical label calls for consistent use with food or without food; check the current label for the actual product with a pharmacist rather than alternating." } ], "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "BuSpar", "generic": "盐酸丁螺环酮", "dosageFormClass": "口服固体制剂" }, "labelSource": { "id": "src_e536090c802955f0", "label": "DailyMed: Rising Pharma buspirone hydrochloride generic tablets; page updated 2026-03-02, printed issue 02/2025; not BuSpar packaging", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b9aa144c-cb36-4069-9eaa-7c150298cdd7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "productRoutes": [ { "source": { "id": "src_e536090c802955f0", "label": "DailyMed: Rising Pharma buspirone hydrochloride generic tablets; page updated 2026-03-02, printed issue 02/2025; not BuSpar packaging", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b9aa144c-cb36-4069-9eaa-7c150298cdd7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "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": "2026-09-09", "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_12fc3bee448dbaba", "label": "FDA Drugs@FDA: BuSpar / buspirone hydrochloride, NDA 018731, historical discontinued RLD tablets", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018731", "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": "2026-09-09", "reviewedAt": "2026-09-09" }, "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": "2026-09-09", "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_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "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": "2026-09-09", "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": "2026-09-09", "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": "先认成分：丁螺环酮是处方抗焦虑药，BuSpar 是历史品牌。再认数字：mg 是每片含量，瓶装片数是整瓶数量。最后带完整药单请药师核对，尤其是抗抑郁药、助眠药及利奈唑胺；不要自行停换原有药物。", "history": "FDA 记录 BuSpar 于 1986-09-29 按新分子实体批准。当前 NDA 018731 所列 5、10、15、30 mg 口服片均为停止销售的 RLD，且注明并非因安全性或有效性原因停止销售。2010 年品牌标签仍可作为历史阅读资料；Rising Pharma 的较新通用药标签须作为另一产品单独阅读。", "sourceDocuments": [ { "id": "src_12fc3bee448dbaba", "label": "FDA Drugs@FDA: BuSpar / buspirone hydrochloride, NDA 018731, historical discontinued RLD tablets", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018731", "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": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_e536090c802955f0", "label": "DailyMed: Rising Pharma buspirone hydrochloride generic tablets; page updated 2026-03-02, printed issue 02/2025; not BuSpar packaging", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b9aa144c-cb36-4069-9eaa-7c150298cdd7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } ], "applicationNumber": "NDA 018731", "approvalTimeline": [ { "date": "1986-09-29", "title": { "zh": "美国初始批准", "en": "Initial U.S. approval" }, "detail": { "zh": "FDA 原始申请按新分子实体批准。", "en": "FDA approved the original application as a new molecular entity." }, "source": { "id": "src_12fc3bee448dbaba", "label": "FDA Drugs@FDA: BuSpar / buspirone hydrochloride, NDA 018731, historical discontinued RLD tablets", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018731", "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": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2010-11-22", "title": { "zh": "历史品牌标签补充批准", "en": "Historical brand labeling supplement" }, "detail": { "zh": "S-051 标签列有五个瓶装及特定 DIVIDOSE 片的患者说明。", "en": "The S-051 label lists five bottle presentations and patient instructions for the specific DIVIDOSE tablets." }, "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史品牌所列四个强度均停止销售", "en": "Four listed historical brand strengths discontinued" }, "detail": { "zh": "FDA 所列 5、10、15、30 mg 均为 RLD、非 RS；停止销售并不等同于因安全性原因撤回。", "en": "FDA lists 5, 10, 15 and 30 mg as discontinued RLDs, not RS, with a determination that withdrawal was not for safety or effectiveness." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "现行市场记录待核验", "en": "Current market record not established" }, "detail": { "zh": "未从美国档案推定中国品牌、批准、规格、供应或可替代性。", "en": "No Chinese brand, approval, strength, supply or interchangeability is inferred from U.S. records." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "药片有刻痕就能自己掰吗？", "en": "Does a score mean I can split it myself?" }, "answer": { "zh": "需看具体产品及处方。2010 年 BuSpar 标签允许特定 5／10 mg 片对半分、特定 15／30 mg DIVIDOSE 片对半或三等分；不能外推到任何厂牌，也不提供个人片数。", "en": "Check the exact product and prescription. The 2010 label describes halves for specific 5/10 mg tablets and halves or thirds for specific 15/30 mg DIVIDOSE tablets, not every manufacturer or an individual regimen." } }, { "question": { "zh": "为什么标签上还有 7.5 mg？", "en": "Why might another label list 7.5 mg?" }, "answer": { "zh": "当前通用药可以有不同规格。这里 NDA 018731 的品牌产品表只有 5、10、15、30 mg；不要把通用药的 7.5 mg 自动补进历史品牌表。", "en": "A generic product may have different strengths. The NDA 018731 brand table here lists 5, 10, 15 and 30 mg; a generic 7.5 mg product must not be inserted into it." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/buspar-buspirone/", "en": "https://origindrug.com/en/drugs/buspar-buspirone/" }, "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." ] }