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 6 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAPNAR PHARMA LP3c115eea-9dbc-4e2c-9d79-42e3388fde5a2024-06-17Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
rxcui: 866018
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEAmerican Health Packaginge80d83a6-7c2a-478e-bdf1-c481824fc3012024-06-07Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC19afb386-72a5-c97e-e063-6294a90adaea2024-05-30Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutionscff1c7b2-4edb-4b5a-9626-2f7b8671b0152024-05-22Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONEBoswell Pharmacy Services d/b/a BPS Wholesale18e90d65-4a3a-864e-e063-6294a90ae99d2024-05-15Warnings, Adverse reactionsExact identifier
rxcui: 866083
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions2a25a718-306f-403e-9928-cae30bc52f122024-05-06Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackeab53fff-c052-4466-a673-3d68aab98c272024-04-05Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack2a8b3b75-5d93-4a9e-a583-49ccddd656502024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepacka738c103-134a-401f-b14c-49a599130b8d2024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 866083
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack5fa0720f-e236-4b8b-a0c0-6f48037c76b32024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP1886b672-4b88-4b49-ae6a-d2ba2f452e442024-01-01Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutionsbce96786-4d9a-460e-8d92-9908ea2af07a2023-12-27Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.a6bdf140-075e-445e-a62d-633a4b97f3a82023-12-22Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
rxcui: 866018
BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackd47cde56-e1ab-41fe-832e-d3f33b884a5e2023-11-28Warnings, Adverse reactionsExact identifier
rxcui: 866083
BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEA-S Medication Solutions501b0406-f56e-44d3-906a-7625b936f0752023-11-01Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions96789fdc-f3a0-4441-b9f4-2be2d9c6273b2023-10-16Warnings, Adverse reactionsExact identifier
rxcui: 866083
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.6fac36b4-b223-479e-913f-f8c9cdb9e1192023-07-23Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
rxcui: 866018
BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack2bc87b32-bdb7-4ce6-8a51-aed623f7219e2023-06-05Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP864ddd0c-80e5-4b4b-84e9-7d66214464ae2023-05-01Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP9a702362-39cb-4171-8d64-f37fa7e1f6382022-08-01Warnings, Adverse reactionsExact identifier
rxcui: 866018

Reported adverse events (FAERS/openFDA)#

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