FDA.reportPublic FDA data

NDC 80425-0303-01 - 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
80425-0303
Requested NDC
80425-0303-01
Package NDCs from labels
80425-0303-1, 80425-0303-2, 80425-0303-3, 80425-0303-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Buspirone Hydrochloride - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0303-1Buspirone Hydrochloride30 in 1 BOTTLETABLET302
80425-0303-2Buspirone Hydrochloride60 in 1 BOTTLETABLET602
80425-0303-3Buspirone Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0303BUSPIRONE HYDROCHLORIDE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f8afd9b8-0885-2f0c-e053-6294a90a9c57.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0303-1EA - Each80425-0303f4913649-e1ba-42f9-8427-a607b54d7ddf12023-06-06
80425-0303-2EA - Each80425-030337cb4f00-cf48-48e7-87f2-e17af97a000112023-06-06
80425-0303-3EA - Each80425-03039453aa87-69d6-4b8b-9098-5a9978f87ac712023-06-06

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 9 · 165 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENuCare Pharmaceuticals, Inc.540e9b7e-09ff-2cca-e054-00144ff8d46c2024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 866083
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack267d8897-90dd-4f8a-bbd8-8aa4e47c29052024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 866083
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackdb32a7ec-5b50-4305-8952-df22e7e871e22024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAPNAR PHARMA LP3c115eea-9dbc-4e2c-9d79-42e3388fde5a2024-06-17Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866090
rxcui: 866094
rxcui: 866018
unii: 207LT9J9OC
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEAmerican Health Packaginge80d83a6-7c2a-478e-bdf1-c481824fc3012024-06-07Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866018
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC19afb386-72a5-c97e-e063-6294a90adaea2024-05-30Warnings, Adverse reactionsExact identifier
application number: ANDA210907
rxcui: 866018
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutionscff1c7b2-4edb-4b5a-9626-2f7b8671b0152024-05-22Warnings, Adverse reactionsExact identifier
rxcui: 866018
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONEBoswell Pharmacy Services d/b/a BPS Wholesale18e90d65-4a3a-864e-e063-6294a90ae99d2024-05-15Warnings, Adverse reactionsExact identifier
rxcui: 866083
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions2a25a718-306f-403e-9928-cae30bc52f122024-05-06Warnings, Adverse reactionsExact identifier
application number: ANDA210907
rxcui: 866018
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepacka2867dde-e5dd-4cc8-84d0-59240626868a2024-04-05Warnings, Adverse reactionsExact identifier
application number: ANDA210907
rxcui: 866090
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackeab53fff-c052-4466-a673-3d68aab98c272024-04-05Warnings, Adverse reactionsExact identifier
application number: ANDA210907
rxcui: 866094
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack2a8b3b75-5d93-4a9e-a583-49ccddd656502024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 866018
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepacka738c103-134a-401f-b14c-49a599130b8d2024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 866083
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack5fa0720f-e236-4b8b-a0c0-6f48037c76b32024-04-03Warnings, Adverse reactionsExact identifier
application number: ANDA210907
rxcui: 866018
unii: 207LT9J9OC
BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEProficient Rx LP75b1ae3f-e926-4555-a0e9-50323fc66cb22024-02-01Warnings, Adverse reactionsExact identifier
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEProficient Rx LP1886b672-4b88-4b49-ae6a-d2ba2f452e442024-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA210907
rxcui: 866094
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutionsbce96786-4d9a-460e-8d92-9908ea2af07a2023-12-27Warnings, Adverse reactionsExact identifier
application number: ANDA210907
rxcui: 866018
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.a6bdf140-075e-445e-a62d-633a4b97f3a82023-12-22Warnings, Adverse reactionsExact identifier
application number: ANDA210907
ndc (product): 29300-246
rxcui: 866083
rxcui: 866090
rxcui: 866094
rxcui: 866018
spl id: ef78a61a-865b-447a-9324-3044e41db506
spl set id: a6bdf140-075e-445e-a62d-633a4b97f3a8
unii: 207LT9J9OC
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackb07c0a91-892c-47f5-819e-a128e0ef1ed72023-12-15Warnings, Adverse reactionsExact identifier
unii: 207LT9J9OC
BUSPIRONE HYDROCHLORIDEBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack55e32128-711d-4e95-b58b-e86e0afa49832023-12-05Warnings, Adverse reactionsExact identifier
unii: 207LT9J9OC

Reported adverse events (FAERS/openFDA)#

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