Buspirone Hydrochloride
- Product NDC
- 0615-7633
- 11-digit product format
- 006157633
- Labeler code
- 0615
- Product ID
- 0615-7633_68145eef-7e8e-4817-bab3-8ca8d579ce85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA075022
- Marketing category
- ANDA
- Marketing start
- 2010-12-23
- Marketing end
- 0000-00-00
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 5 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 | 0615-7633 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 0615-7633 | 0615-7633-39 | 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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0615-7633-39 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0615-7633-39 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0615-7633-39 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0615-7633-39 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0615-7633-39 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0615-7633-39 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0615-7633-39 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0615-7633-39 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0615-7633-39 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0615-7633-39 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0615-7633-39 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0615-7633-39 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 0615-7633-39 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 0615-7633-39 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 0615-7633-39 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 0615-7633-39 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 0615-7633-39 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 0615-7633-39 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | I | Inactivated by FDA | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 0615-7633-39 | I | Inactivated by FDA | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075022-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | |
| A075022-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | |
| A075022-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | |
| A075022-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075022-001 | AB |
| A075022-002 | AB |
| A075022-003 | AB |
| A075022-004 | 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 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | 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 | A075022-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075022-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075022-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075022-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-004 | AB | 1 | d06236e962d9… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0615-7633-39 | 2022-11-02 | C162847 | 48780-1 | 960f7f55-c056-8e05-e053-dbdaa90a074a | BusPIRone HYDROCHLORIDE TABLETS USP 0053 0054 1003 5200 Rx only |
| 0615-7633-39 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c056-8e05-e053-dbdaa90a074a | BusPIRone HYDROCHLORIDE TABLETS USP 0053 0054 1003 5200 Rx only |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BUSPIRONE HYDROCHLORIDE | ACTIVE INGREDIENT | 207LT9J9OC | BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | |
| BUSPIRONE | ACTIVE MOIETY | TK65WKS8HL | BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BUSPIRONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 1 |
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 | Redpharm Drug | 5718bc19-07b2-b61d-e063-6394a90a6e80 | 2026-07-21 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 459cc50d-0b18-ac1d-e063-6294a90ae7c4 | 2026-03-26 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Northwind Health Company, LLC | ff02c7cb-f96a-4a3b-99a2-812cd78b345c | 2025-12-26 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 438f5c4d-a009-b851-e063-6394a90a084a | 2025-11-13 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 3b41fd76-c3cc-77f0-e063-6294a90aa778 | 2025-07-31 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 4adc1750-b89e-473d-a18f-949423a2354f | 2025-01-08 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | a8720833-3bbc-4714-b9b8-716c5e55410d | 2024-10-21 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | d5fcc60d-5465-4075-948c-1aa4ff21af4c | 2024-09-27 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 72bff09c-826e-4394-a7e7-41d56ce9605b | 2024-09-24 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | db32a7ec-5b50-4305-8952-df22e7e871e2 | 2024-07-09 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | cff1c7b2-4edb-4b5a-9626-2f7b8671b015 | 2024-05-22 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE | Boswell Pharmacy Services d/b/a BPS Wholesale | 18e90d65-4a3a-864e-e063-6294a90ae99d | 2024-05-15 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 96789fdc-f3a0-4441-b9f4-2be2d9c6273b | 2023-10-16 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 6fac36b4-b223-479e-913f-f8c9cdb9e119 | 2023-07-23 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Proficient Rx LP | 864ddd0c-80e5-4b4b-84e9-7d66214464ae | 2023-05-01 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Proficient Rx LP | 9a702362-39cb-4171-8d64-f37fa7e1f638 | 2022-08-01 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Proficient Rx LP | 69eb15e9-c33e-40a3-82d8-497dad13068d | 2022-04-01 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | efa03f52-430e-455a-bdca-7f9d422b7b19 | 2019-01-08 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | b7e3a98c-9ec5-4c21-9218-0d53a555a75c | 2018-11-08 | Warnings, Adverse reactions | 075022 ANDA075022 |