FDA.reportPublic FDA data

NDC 58177-264 - Buspirone Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58177-264
Package NDCs from labels
58177-264-04, 58177-264-08
Manufacturer
ETHEX
Effective date
2007-04-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Buspirone Hydrochloride - ETHEXETHEX2007-04-18Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58177-264-04Buspirone Hydrochloride100 in 1 BOTTLETABLET1001
58177-264-08Buspirone Hydrochloride500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58177-264BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [ETHEX]12 package rows20080313_239dcefe-45a9-48f5-a6f1-1ac6546e0da2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
buspirone hydrochlorideACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [ETHEX]1
buspironeACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [ETHEX]1
alumina hydrateINACTIVE INGREDIENTBUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [ETHEX]1
colloidal silicon dioxideINACTIVE INGREDIENTBUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [ETHEX]1
D&C yellow no. 10 lakeINACTIVE INGREDIENTBUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [ETHEX]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [ETHEX]1
magnesium stearateINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [ETHEX]1
microcrystalline celluloseINACTIVE INGREDIENTBUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [ETHEX]1
sodium starch glycolateINACTIVE INGREDIENTBUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) TABLET [ETHEX]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackbee0edbf-3fc3-484b-9715-f13a329216ae2025-11-03Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack4e7640d1-0a31-4f97-82bb-574cf1ff6e4a2025-10-28Warnings, Adverse reactionsExact identifier
rxcui: 866083
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC40d5813d-d040-002c-e063-6294a90a5f7a2025-10-10Warnings, Adverse reactionsExact identifier
rxcui: 866083
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions7c7225a0-8237-4998-843a-bf10fa6ec65b2025-10-09Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAccord Healthcare Inc.3da22999-f5fb-49fd-acde-c3006598e9852025-10-07Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack2df0b238-14a4-40ca-a235-411f6c9b83382025-10-06Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackf85b59b7-b945-4440-8378-987bd287a6552025-10-01Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b217f341-7d51-475d-887f-f16786164c7b2025-10-01Warnings, Adverse reactionsExact identifier
rxcui: 866083
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.270398a0-21b8-407b-af76-4aeef90f72be2025-10-01Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDERadha Pharmaceuticals, Inc.3f66a3fe-9d73-180c-e063-6394a90aacca2025-09-22Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3dd7f213-afd8-67d6-e063-6294a90ac1082025-09-08Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack65c69118-36bb-4f0d-9669-b52556056ec52025-09-04Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepacked7e334a-cc4a-47b2-a4db-56495730b6982025-09-03Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack5d93a30e-3544-44e7-ab6a-dc9dc79d7c712025-09-03Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEStrides Pharma Science Limitedcff9f09a-1ea2-4968-b57b-e62bebaae2382025-09-02Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1790d63d-ecb1-da9d-e063-6294a90a50ba2025-08-19Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEOxford Pharmaceuticals, LLC97fcebc1-6615-4b9d-b0f3-6434850f407c2025-08-14Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENuCare Pharmaceuticals, Inc.3b41fd76-c3cc-77f0-e063-6294a90aa7782025-07-31Warnings, Adverse reactionsExact identifier
rxcui: 866083
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEMylan Institutional Inc.91bb5fc9-5121-43c2-b2af-149240d4189a2025-07-18Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
rxcui: 866018
Buspirone HCLBUSPIRONE HCLDirect_Rx3246dd4d-f787-2f62-e063-6294a90a9cd22025-06-25Warnings, Adverse reactionsExact identifier
rxcui: 866018

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.