Buspirone hydrochloride
- Product NDC
- 50436-0182
- 11-digit product format
- 504360182
- Labeler code
- 50436
- Product ID
- 50436-0182_2f052daf-b20f-4085-a17d-a3de59ca10cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA078888
- Marketing category
- ANDA
- Marketing start
- 2014-05-03
- Marketing end
- 0000-00-00
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 15 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 50436-0182 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 50436-0182 | 50436-0182-1 | I | Inactivated by FDA | 2026-08-17 |
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 | 50436-0182-1 | 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 | 50436-0182-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50436-0182-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50436-0182-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50436-0182-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50436-0182-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50436-0182-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50436-0182-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50436-0182-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50436-0182-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50436-0182-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50436-0182-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50436-0182-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50436-0182-1 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50436-0182-1 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 50436-0182-1 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 50436-0182-1 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 50436-0182-1 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 50436-0182-1 | 8dfbde2a14a4… | c9ff85d89658… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078888-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | |
| A078888-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | |
| A078888-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | |
| A078888-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | |
| A078888-005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078888-001 | AB |
| A078888-002 | AB |
| A078888-003 | AB |
| A078888-004 | AB |
| A078888-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078888-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078888-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078888-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078888-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078888-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-005 | AB | 1 | 2680178bc6a6… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a9968269-ddf2-400e-9170-7376dcf3545a | Product name | 1 | 20251215 |
| 2cf3c2e9-d566-c982-009a-188fe4f776b9 | Product name | 8 | 20200428 |
| 4a9096ce-7b98-89e5-5942-15f48c4f7abf | Product name | 5 | 20190711 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-0182-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5b08-a910-e053-dadaa90a0b85 | Buspirone Hydrochloride Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-0182-1 | Buspirone hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-0182 | BUSPIRONE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES] | 2 | Legacy NDC, 1 package rows | 20190921_016d43b5-20a0-4861-96f8-6537f2c2f763.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 | Major Pharmaceuticals | a9bb9216-3dac-4e8a-9df9-f72c2eaef160 | 2026-06-30 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 544b8918-7175-655f-e063-6394a90a453a | 2026-06-15 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Coupler LLC | 53e7576a-e2f4-042b-e063-6294a90ae035 | 2026-06-10 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | fa3f9c0e-261d-4ceb-8cc7-e5e013563479 | 2026-06-10 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Cardinal Health 107, LLC | 1315494d-7a51-4395-bc7c-afb4bc5482c9 | 2026-04-24 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | AvPAK | b230197c-3d50-7874-e053-2a95a90af50f | 2026-03-04 | Warnings, Adverse reactions | 078888 ANDA078888 |
| buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Zydus Lifesciences Limited | 1109dd63-6492-49b1-a383-3ab3a80cd6c7 | 2025-12-24 | 078888 ANDA078888 | |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 8c811d3a-8b2d-44f5-bc8f-8eb563f18c3f | 2025-11-10 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 08efb26e-488c-49d4-8432-98db855962e9 | 2025-03-31 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 897dac69-a59b-423c-be16-6301c7e504d9 | 2025-03-28 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 2025-02-12 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | 7ac98a7f-0ded-427f-899a-c3f6d1997403 | 2025-01-09 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | American Health Packaging | e80d83a6-7c2a-478e-bdf1-c481824fc301 | 2024-06-07 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | b07c0a91-892c-47f5-819e-a128e0ef1ed7 | 2023-12-15 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 7f6986a8-59dc-4dc3-bac0-b38cfc689f8f | 2019-04-29 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 310c6bea-838b-43e4-87e0-a0050829c242 | 2018-12-19 | Warnings, Adverse reactions | 078888 ANDA078888 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866018 | busPIRone HCl 15 MG Oral Tablet | PSN | 016d43b5-20a0-4861-96f8-6537f2c2f763 | 2 |
| 866018 | buspirone hydrochloride 15 MG Oral Tablet | SCD | 016d43b5-20a0-4861-96f8-6537f2c2f763 | 2 |
| 866018 | buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet | SY | 016d43b5-20a0-4861-96f8-6537f2c2f763 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-0182-1 | 50436018201 | 30 in 1 BOTTLE | Historical |