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 7 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP24a95296-5fbe-49df-b1fe-4760d3a5ffe12022-07-01Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP69eb15e9-c33e-40a3-82d8-497dad13068d2022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 866083
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC0d46cf24-07e1-4bb7-8b5b-5ce12a030afd2022-03-16Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCfbab1056-b63e-473e-9259-ba099d884d2b2021-10-28Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCfa8171d4-f73c-4a91-973d-cb46c55070812021-09-29Warnings, Adverse reactionsExact identifier
rxcui: 866083
BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEAurobindo Pharma Limited05c006d2-44b9-431f-bce2-aff09c043ecb2021-07-05Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
rxcui: 866018
BusPIRone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP03efd618-8ca3-43d0-bbeb-55e53b5308e82020-04-01Warnings, Adverse reactionsExact identifier
rxcui: 866018
BusPIRone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCe2c672b3-6130-4dd1-8066-0ce9451cb8c72019-06-06Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEEpic Pharma, LLC02628a0c-bfdb-4a58-8e48-bcd8ca12d53b2019-05-03Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
rxcui: 866018
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC7f6986a8-59dc-4dc3-bac0-b38cfc689f8f2019-04-29Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCefa03f52-430e-455a-bdca-7f9d422b7b192019-01-08Warnings, Adverse reactionsExact identifier
rxcui: 866094
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCfac49d42-7bc0-435f-bce2-2548dcdd6de62018-12-20Warnings, Adverse reactionsExact identifier
rxcui: 866083
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC310c6bea-838b-43e4-87e0-a0050829c2422018-12-19Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCb7e3a98c-9ec5-4c21-9218-0d53a555a75c2018-11-08Warnings, Adverse reactionsExact identifier
rxcui: 866018
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC8b6e7ae6-5b83-4a5a-ab45-cf4be4287d782018-10-18Warnings, Adverse reactionsExact identifier
rxcui: 866094
73459137-1214-D3C2-D4AE-F7AF98371F26239dcefe-45a9-48f5-a6f1-1ac6546e0da22007-04-18Warnings, Adverse reactionsExact identifier
spl id: 73459137-1214-D3C2-D4AE-F7AF98371F26
spl set id: 239dcefe-45a9-48f5-a6f1-1ac6546e0da2

Reported adverse events (FAERS/openFDA)#

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