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 5 of 9 · 166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.270398a0-21b8-407b-af76-4aeef90f72be2025-10-01Warnings, Adverse reactionsExact identifier
rxcui: 866018
unii: 207LT9J9OC
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDERadha Pharmaceuticals, Inc.3f66a3fe-9d73-180c-e063-6394a90aacca2025-09-22Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866090
rxcui: 866094
rxcui: 866018
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions48b4e52d-d4c4-4d24-a0ac-24316371cef02025-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA210907
rxcui: 866090
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3dd7f213-afd8-67d6-e063-6294a90ac1082025-09-08Warnings, Adverse reactionsExact identifier
rxcui: 866094
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack65c69118-36bb-4f0d-9669-b52556056ec52025-09-04Warnings, Adverse reactionsExact identifier
rxcui: 866018
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepacked7e334a-cc4a-47b2-a4db-56495730b6982025-09-03Warnings, Adverse reactionsExact identifier
rxcui: 866094
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack5d93a30e-3544-44e7-ab6a-dc9dc79d7c712025-09-03Warnings, Adverse reactionsExact identifier
rxcui: 866094
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEStrides Pharma Science Limitedcff9f09a-1ea2-4968-b57b-e62bebaae2382025-09-02Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866090
rxcui: 866094
rxcui: 866018
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1790d63d-ecb1-da9d-e063-6294a90a50ba2025-08-19Warnings, Adverse reactionsExact identifier
rxcui: 866094
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEOxford Pharmaceuticals, LLC97fcebc1-6615-4b9d-b0f3-6434850f407c2025-08-14Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866090
rxcui: 866094
rxcui: 866018
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENuCare Pharmaceuticals, Inc.3b41fd76-c3cc-77f0-e063-6294a90aa7782025-07-31Warnings, Adverse reactionsExact identifier
rxcui: 866083
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEMylan Institutional Inc.91bb5fc9-5121-43c2-b2af-149240d4189a2025-07-18Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866090
rxcui: 866094
rxcui: 866018
unii: 207LT9J9OC
Buspirone HCLBUSPIRONE HCLDirect_Rx3246dd4d-f787-2f62-e063-6294a90a9cd22025-06-25Warnings, Adverse reactionsExact identifier
application number: ANDA210907
rxcui: 866018
unii: 207LT9J9OC
Buspirone HCLBUSPIRONE HCLDirect_Rx37780596-3b6f-8d00-e063-6294a90ad4ad2025-06-13Warnings, Adverse reactionsExact identifier
application number: ANDA210907
rxcui: 866094
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack63e2d4e2-f1ab-480d-b0bb-79b6cdb57a5d2025-05-12Warnings, Adverse reactionsExact identifier
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENuCare Pharmaceuticals, Inc.335107c9-5799-c4df-e063-6294a90a5ca02025-04-21Warnings, Adverse reactionsExact identifier
application number: ANDA210907
rxcui: 866018
unii: 207LT9J9OC
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack08efb26e-488c-49d4-8432-98db855962e92025-03-31Warnings, Adverse reactionsExact identifier
unii: 207LT9J9OC
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack897dac69-a59b-423c-be16-6301c7e504d92025-03-28Warnings, Adverse reactionsExact identifier
rxcui: 866083
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackb6352207-e708-44a7-8a63-93b96613e1e72025-03-27Warnings, Adverse reactionsExact identifier
application number: ANDA210907
rxcui: 866083
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC30c93022-4126-db8c-e063-6394a90a75792025-03-20Warnings, Adverse reactionsExact identifier
application number: ANDA210907
rxcui: 866094
unii: 207LT9J9OC

Reported adverse events (FAERS/openFDA)#

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