Buspirone Hydrochloride
- Product NDC
- 70518-2803
- 11-digit product format
- 705182803
- Labeler code
- 70518
- Product ID
- 70518-2803_d7317168-41c3-1e3f-e053-2a95a90abdd4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA210907
- Marketing category
- ANDA
- Marketing start
- 2020-07-01
- Marketing end
- 0000-00-00
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 30 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 product | product | 70518-2803 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 70518-2803 | 70518-2803-0 | D | Discontinued by firm | 2026-10-05 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-2803-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-2803-0 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210907-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | |
| A210907-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | |
| A210907-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 |
| A210907-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210907-001 | AB |
| A210907-002 | AB |
| A210907-003 | AB |
| A210907-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A210907-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210907-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210907-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210907-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A210907-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210907-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210907-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210907-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-004 | AB | 1 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70518-2803-0 | 2022-02-04 | C162847 | 48780-1 | d6a99b39-ae52-a426-e053-dadaa90af4c2 | Buspirone Hydrochloride Tablets, USP Rx Only |
| 70518-2803-0 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ae52-a426-e053-dadaa90af4c2 | Buspirone Hydrochloride Tablets, USP Rx Only |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-2803 | BUSPIRONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] | 5 | Legacy NDC | 20250403_c8a58d3b-cf61-4a17-a3fa-3bd78539a69c.zip |
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 | Bryant Ranch Prepack | 20866697-58cd-4639-ae21-2fff486aec81 | 2025-02-05 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | fbd7f3fa-11f8-a319-e053-6294a90acae4 | 2025-02-04 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hcl | BUSPIRONE HCL | Direct Rx | da584ae1-4513-6474-e053-2a95a90aac9d | 2025-01-20 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f8afd9b8-0885-2f0c-e053-6294a90a9c57 | 2024-12-31 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 932422a8-b72c-4dab-b942-2ab092ed6b01 | 2024-12-12 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 38faa7cb-d858-4481-8649-35d228acbd38 | 2024-08-20 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | 19afb386-72a5-c97e-e063-6294a90adaea | 2024-05-30 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 2a25a718-306f-403e-9928-cae30bc52f12 | 2024-05-06 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | a2867dde-e5dd-4cc8-84d0-59240626868a | 2024-04-05 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | eab53fff-c052-4466-a673-3d68aab98c27 | 2024-04-05 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 5fa0720f-e236-4b8b-a0c0-6f48037c76b3 | 2024-04-03 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Proficient Rx LP | 1886b672-4b88-4b49-ae6a-d2ba2f452e44 | 2024-01-01 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | bce96786-4d9a-460e-8d92-9908ea2af07a | 2023-12-27 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | a6bdf140-075e-445e-a62d-633a4b97f3a8 | 2023-12-22 | Warnings, Adverse reactions | 210907 ANDA210907 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-2803-0 | 70518280300 | 30 TABLET in 1 BLISTER PACK (70518-2803-0) | 30 tablet | 2020-07-01 | 0000-00-00 | No | No | Current |