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 | Type |
|---|---|---|---|
| Buspirone Hydrochloride - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0303-1 | Buspirone Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 80425-0303-2 | Buspirone Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 2 | |
| 80425-0303-3 | Buspirone Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0303 | BUSPIRONE HYDROCHLORIDE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, 3 package rows | 20250102_f8afd9b8-0885-2f0c-e053-6294a90a9c57.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0303-1 | EA - Each | 80425-0303 | f4913649-e1ba-42f9-8427-a607b54d7ddf | 1 | 2023-06-06 |
| 80425-0303-2 | EA - Each | 80425-0303 | 37cb4f00-cf48-48e7-87f2-e17af97a0001 | 1 | 2023-06-06 |
| 80425-0303-3 | EA - Each | 80425-0303 | 9453aa87-69d6-4b8b-9098-5a9978f87ac7 | 1 | 2023-06-06 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 544b8918-7175-655f-e063-6394a90a453a | 2026-06-15 | Warnings, Adverse reactions | 866018 207LT9J9OC |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 2026-06-15 | Warnings, Adverse reactions | 866083 866090 866094 866018 207LT9J9OC |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | fbff8248-b73c-474e-907e-449f8316c629 | 2026-06-12 | Warnings, Adverse reactions | ANDA210907 866018 207LT9J9OC |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Coupler LLC | 53e7576a-e2f4-042b-e063-6294a90ae035 | 2026-06-10 | Warnings, Adverse reactions | 207LT9J9OC |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | fa3f9c0e-261d-4ceb-8cc7-e5e013563479 | 2026-06-10 | Warnings, Adverse reactions | 207LT9J9OC |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 66df7f74-5dea-46d6-9ef8-9bab37baf407 | 2026-05-14 | Warnings, Adverse reactions | 866083 207LT9J9OC |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 225575f1-9635-4922-8286-d479d6480bf0 | 2026-05-13 | Warnings, Adverse reactions | 866018 207LT9J9OC |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | eee7fa99-a9a1-4299-8a3d-6c2dd90948c9 | 2026-05-13 | Warnings, Adverse reactions | 866090 207LT9J9OC |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Asclemed USA, Inc. | 97f2d082-0931-4e4f-a5be-7792e399e42b | 2026-05-04 | Warnings, Adverse reactions | ANDA210907 866083 866090 866094 866018 207LT9J9OC |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Coupler LLC | 510120d3-c922-a071-e063-6294a90af6a7 | 2026-05-04 | Warnings, Adverse reactions | ANDA210907 866094 207LT9J9OC |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 50b18368-d37c-374b-e063-6394a90a8114 | 2026-04-30 | Warnings, Adverse reactions | 866083 207LT9J9OC |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Cardinal Health 107, LLC | 1315494d-7a51-4395-bc7c-afb4bc5482c9 | 2026-04-24 | Warnings, Adverse reactions | 866018 207LT9J9OC |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | 5b4da3f8-a5ce-4699-92e1-37fb95e0af2d | 2026-04-23 | Warnings, Adverse reactions | ANDA210907 866094 207LT9J9OC |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Cardinal Health 107, LLC | 5424f933-93e1-4480-acdf-bd8667ae50e9 | 2026-04-15 | Warnings, Adverse reactions | 866083 866094 207LT9J9OC |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 093b701d-4a43-4871-b726-c5820fa3ab95 | 2026-04-14 | Warnings, Adverse reactions | 866083 207LT9J9OC |
| busPIRone HCl | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 138b84a5-966b-47d7-a3d6-395df83f8aa5 | 2026-04-08 | Warnings, Adverse reactions | 866083 207LT9J9OC |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | 6c6db7a9-a728-406a-81af-edd89e1cc26f | 2026-04-07 | Warnings, Adverse reactions | ANDA210907 866083 207LT9J9OC |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 459cc50d-0b18-ac1d-e063-6294a90ae7c4 | 2026-03-26 | Warnings, Adverse reactions | 866083 207LT9J9OC |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 824c80e6-d508-405f-8a4f-2f10df5a9dc8 | 2026-03-20 | Warnings, Adverse reactions | ANDA210907 866094 207LT9J9OC |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 187c315b-9c2c-485f-aa63-e399e0796e78 | 2026-03-20 | Warnings, Adverse reactions | ANDA210907 866018 207LT9J9OC |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.