Buspirone Hydrochloride
- Product NDC
- 70518-2830
- Requested package NDC
- 70518-2830-1
- 11-digit product format
- 705182830
- Labeler code
- 70518
- Product ID
- 70518-2830_d76e5c2f-a85e-51dc-e053-2a95a90a5242
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA208972
- Marketing category
- ANDA
- Marketing start
- 2020-08-10
- Marketing end
- 0000-00-00
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 8 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 70518-2830 | 70518-2830-1 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-2830 | 70518-2830-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-2830 | 70518-2830-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208972-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-04-16 | |
| A208972-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2019-04-16 | |
| A208972-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-04-16 | |
| A208972-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-04-16 | |
| A208972-005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-04-16 | |
| A208972-006 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | 2026-05-13 | ||
| A208972-007 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | 2026-05-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208972-001 | AB |
| A208972-002 | AB |
| A208972-003 | AB |
| A208972-004 | AB |
| A208972-005 | 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 | A208972-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | BX | 2019-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208972-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | BX | 2019-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208972-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | BX | 2019-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208972-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | BX | 2019-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208972-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | BX | 2019-04-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208972-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | BX | 2019-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208972-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | BX | 2019-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208972-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | BX | 2019-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208972-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | BX | 2019-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208972-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | BX | 2019-04-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208972-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | BX | 2019-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208972-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | BX | 2019-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208972-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | BX | 2019-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208972-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | BX | 2019-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208972-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | BX | 2019-04-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208972-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-04-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208972-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2019-04-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208972-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-04-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208972-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-04-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208972-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-04-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208972-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-04-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208972-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2019-04-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208972-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-04-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208972-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-04-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208972-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-04-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208972-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-04-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208972-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2019-04-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208972-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-04-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208972-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-04-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208972-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-04-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208972-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-04-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208972-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2019-04-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208972-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-04-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208972-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-04-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208972-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-04-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208972-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-04-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208972-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2019-04-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208972-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-04-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208972-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-04-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208972-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-04-16 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A208972-001 | BX | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208972-002 | BX | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208972-003 | BX | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208972-004 | BX | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208972-005 | BX | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208972-001 | BX | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208972-002 | BX | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208972-003 | BX | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208972-004 | BX | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208972-005 | BX | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208972-001 | BX | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208972-002 | BX | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208972-003 | BX | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208972-004 | BX | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208972-005 | BX | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208972-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208972-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208972-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208972-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208972-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208972-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208972-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208972-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208972-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208972-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208972-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208972-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208972-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208972-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208972-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208972-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208972-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208972-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208972-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208972-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208972-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208972-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208972-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208972-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208972-005 | AB | 1 | 5bbf6a4d5a75… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | IPG Pharmaceuticals, Inc | 2c516eec-65d9-4481-8823-ae6b6da84062 | 2026-06-21 | Warnings, Adverse reactions | 208972 ANDA208972 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 27db85e9-68ef-4d43-a319-4e2ec8dbae05 | 2020-04-09 | Warnings, Adverse reactions | 208972 ANDA208972 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Epic Pharma, LLC | 02628a0c-bfdb-4a58-8e48-bcd8ca12d53b | 2019-05-03 | Warnings, Adverse reactions | 208972 ANDA208972 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70518-2830-0 | 2022-02-07 | C162847 | 48780-1 | d6a99b39-4565-a426-e053-dadaa90af4c2 | Buspirone Hydrochloride Tablets, USP Rx Only (Patient Instruction Sheet Included) |
| 70518-2830-0 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-4565-a426-e053-dadaa90af4c2 | Buspirone Hydrochloride Tablets, USP Rx Only (Patient Instruction Sheet Included) |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-2830-1 | 70518283001 | 30 TABLET in 1 BLISTER PACK (70518-2830-1) | 30 tablet | 2021-01-30 | 0000-00-00 | No | No | Current |