FDA.reportPublic FDA data

NDC 58177-309 - 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
58177-309
Package NDCs from labels
58177-309-04, 58177-309-08
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
58177-309-04Buspirone Hydrochloride100 in 1 BOTTLETABLET1001
58177-309-08Buspirone Hydrochloride500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58177-309BUSPIRONE 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 1 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDECardinal Health 107, LLCef90af23-d97e-4094-971b-1d8114218b102026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEMajor Pharmaceuticals8dc1ee33-e5aa-4462-8fb9-9bbdf54634882026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP801803eb-be17-4064-8813-7ccf52316cde2026-08-01Warnings, Adverse reactionsExact identifier
rxcui: 866083
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.3155e607-bc7f-4e90-9edf-8e862dd5737d2026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEAiPing Pharmaceutical, Inc.55810b17-4796-49d0-90e4-8e075d62eda42026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDECardinal Health 107, LLC2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd2026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.fd05160d-24c6-4371-8b2c-c0f78c8b468e2026-07-28Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEGolden State Medical Supply, Inc.bcce49d3-c8eb-9f9b-e053-2995a90a67d92026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
rxcui: 866018
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions7b222cb0-0061-4a3e-9d0f-e9f120e7f5d92026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDERedpharm Drug5718bc19-07b2-b61d-e063-6394a90a6e802026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 866083
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.a9fc7091-b3ce-45fd-8d89-aeebdd81c3272026-07-16Warnings, Adverse reactionsExact identifier
rxcui: 866083
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEStrides Pharma Inc.cb0091ad-97f6-431b-b2b9-e03171eed2742026-07-08Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.b42cc365-6259-4d2e-9648-d37718b65e1e2026-06-30Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEMajor Pharmaceuticalsa9bb9216-3dac-4e8a-9df9-f72c2eaef1602026-06-30Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENorthwind Health Company, LLC1d883a13-4877-c6c7-e063-6294a90a51372026-06-19Warnings, Adverse reactionsExact identifier
rxcui: 866083
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEUnit Dose Solutions, Inc.544a4570-bd7f-72bb-e063-6394a90ab8d62026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEUnit Dose Solutions, Inc.544b8918-7175-655f-e063-6394a90a453a2026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEMylan Pharmaceuticals Inc.7c9eafb9-9ce1-4b28-900c-8fcb4b23424e2026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.fbff8248-b73c-474e-907e-449f8316c6292026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack66df7f74-5dea-46d6-9ef8-9bab37baf4072026-05-14Warnings, Adverse reactionsExact identifier
rxcui: 866083

Reported adverse events (FAERS/openFDA)#

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