Buspirone Hydrochloride
- Product NDC
- 68788-7875
- Requested package NDC
- 68788-7875-9
- 11-digit product format
- 687887875
- Labeler code
- 68788
- Product ID
- 68788-7875_a4ec71b4-e776-40bf-bb57-5dafeb56c826
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buspirone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA075388
- Marketing category
- ANDA
- Marketing start
- 2021-03-08
- Marketing end
- 0000-00-00
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 15 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 68788-7875 | 68788-7875-9 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075388-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | |
| A075388-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | |
| A075388-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075388-001 | AB |
| A075388-002 | AB |
| A075388-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075388-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075388-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075388-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075388-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075388-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075388-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075388-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075388-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075388-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075388-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075388-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075388-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075388-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075388-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075388-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075388-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075388-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075388-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075388-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075388-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075388-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075388-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075388-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075388-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075388-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075388-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075388-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075388-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075388-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075388-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075388-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075388-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075388-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075388-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075388-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075388-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075388-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075388-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075388-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075388-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7875-1 | EA - Each | 68788-7875 | 60174f84-7004-4f4b-ba52-57620c97af45 | 1 | 2021-04-08 |
| 68788-7875-3 | EA - Each | 68788-7875 | b9088371-0628-442f-999e-4d8b643af2e0 | 1 | 2021-04-08 |
| 68788-7875-6 | EA - Each | 68788-7875 | 51fcc0b0-8deb-4301-ac97-8948d14d6dbb | 1 | 2021-04-08 |
| 68788-7875-9 | EA - Each | 68788-7875 | 3abf8b9d-4797-4593-aa2e-06b007f696e2 | 1 | 2021-04-08 |
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 | REMEDYREPACK INC. | 8e0219e9-d305-4473-8229-aee0ee84caf6 | 2026-03-19 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 476f4f55-c6c1-4f39-950e-59236f499577 | 2026-03-18 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 84621631-4c13-4147-ae3c-4ed30d4ebb37 | 2026-03-16 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | 3155e607-bc7f-4e90-9edf-8e862dd5737d | 2026-02-16 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Proficient Rx LP | 1521109d-8386-472f-9483-f1fe9f7ed152 | 2026-01-01 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 338f3317-96c0-4b8a-8299-8ce2a10911ae | 2025-12-02 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | e4d44e49-eb8f-454e-a737-22caf30bda78 | 2025-12-01 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 49659ee7-ca08-4df1-8e6b-3a366a7839c7 | 2025-11-04 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | aba814f0-55ce-4480-99f1-b9ad1ba77d3f | 2025-11-03 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | bee0edbf-3fc3-484b-9715-f13a329216ae | 2025-11-03 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 4e7640d1-0a31-4f97-82bb-574cf1ff6e4a | 2025-10-28 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 40d5813d-d040-002c-e063-6294a90a5f7a | 2025-10-10 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 7c7225a0-8237-4998-843a-bf10fa6ec65b | 2025-10-09 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 2df0b238-14a4-40ca-a235-411f6c9b8338 | 2025-10-06 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | f85b59b7-b945-4440-8378-987bd287a655 | 2025-10-01 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | b217f341-7d51-475d-887f-f16786164c7b | 2025-10-01 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 270398a0-21b8-407b-af76-4aeef90f72be | 2025-10-01 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3dd7f213-afd8-67d6-e063-6294a90ac108 | 2025-09-08 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 65c69118-36bb-4f0d-9669-b52556056ec5 | 2025-09-04 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | ed7e334a-cc4a-47b2-a4db-56495730b698 | 2025-09-03 | Warnings, Adverse reactions | 075388 ANDA075388 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68788-7875-9 | 68788787509 | 90 TABLET in 1 BOTTLE (68788-7875-9) | 90 tablet | 2021-03-08 | 0000-00-00 | No | No | Current |