Buspirone Hydrochloride
- Product NDC
- 70518-2724
- 11-digit product format
- 705182724
- Labeler code
- 70518
- Product ID
- 70518-2724_dc9f9d5b-4110-5e1f-e053-2a95a90a24c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA204582
- Marketing category
- ANDA
- Marketing start
- 2020-05-05
- Marketing end
- 0000-00-00
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 5 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 | 70518-2724 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 70518-2724 | 70518-2724-0 | D | Discontinued by firm | 2026-08-07 |
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 | 70518-2724-0 | 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 | 70518-2724-0 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204582-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | |
| A204582-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | |
| A204582-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | |
| A204582-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204582-001 | AB |
| A204582-002 | AB |
| A204582-003 | AB |
| A204582-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A204582-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204582-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204582-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204582-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-004 | AB | 1 | d06236e962d9… |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-2724 | BUSPIRONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] | 7 | Legacy NDC | 20250331_60e2d6a3-a329-46ef-9df8-079dff32a573.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 | REMEDYREPACK INC. | fd05160d-24c6-4371-8b2c-c0f78c8b468e | 2026-07-28 | Warnings, Adverse reactions | 204582 ANDA204582 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | a9fc7091-b3ce-45fd-8d89-aeebdd81c327 | 2026-07-16 | Warnings, Adverse reactions | 204582 ANDA204582 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 225575f1-9635-4922-8286-d479d6480bf0 | 2026-05-13 | Warnings, Adverse reactions | 204582 ANDA204582 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | eee7fa99-a9a1-4299-8a3d-6c2dd90948c9 | 2026-05-13 | Warnings, Adverse reactions | 204582 ANDA204582 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Cardinal Health 107, LLC | 5424f933-93e1-4480-acdf-bd8667ae50e9 | 2026-04-15 | Warnings, Adverse reactions | 204582 ANDA204582 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Northwind Health Company, LLC | 1d883a13-4877-c6c7-e063-6294a90a5137 | 2025-12-26 | Warnings, Adverse reactions | 204582 ANDA204582 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 4ff72575-bd60-40ce-b3a8-fd92b79af674 | 2025-11-07 | Warnings, Adverse reactions | 204582 ANDA204582 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Major Pharmaceuticals | 8dc1ee33-e5aa-4462-8fb9-9bbdf5463488 | 2025-07-03 | Warnings, Adverse reactions | 204582 ANDA204582 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-2724-0 | 70518272400 | 30 TABLET in 1 BLISTER PACK (70518-2724-0) | 30 tablet | 2020-05-05 | 0000-00-00 | No | No | Current |