busPIRone HCl
- Product NDC
- 50090-4657
- 11-digit product format
- 500904657
- Labeler code
- 50090
- Product ID
- 50090-4657_fe45e4ea-89e8-4b2b-a3c8-814ddfe0c6ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buspirone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA208829
- Marketing category
- ANDA
- Marketing start
- 2017-05-24
- Marketing end
- 0000-00-00
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 15 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 50090-4657 | I | Inactivated by FDA | 2026-10-05 | ||
| excluded package | package | 50090-4657 | 50090-4657-1 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 50090-4657 | 50090-4657-3 | I | Inactivated by FDA | 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 | 50090-4657-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-4657-1 | 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 | 50090-4657-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-4657-1 | 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 | 50090-4657-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-4657-1 | 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 | 50090-4657-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-4657-1 | 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 | 50090-4657-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-4657-1 | 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 | 50090-4657-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-4657-1 | 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 | 50090-4657-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-4657-1 | 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 | 50090-4657-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-4657-1 | 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 | 50090-4657-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-4657-1 | 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 | 50090-4657-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-4657-1 | 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 | 50090-4657-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50090-4657-1 | 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 | 50090-4657-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50090-4657-1 | 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 | 50090-4657-3 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-4657-1 | 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 | 50090-4657-3 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-4657-1 | 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 | 50090-4657-3 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-4657-1 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208829-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | ||
| A208829-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | ||
| A208829-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | ||
| A208829-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | ||
| A208829-005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 |
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 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208829-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208829-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208829-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208829-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208829-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A208829-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A208829-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A208829-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A208829-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A208829-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A208829-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A208829-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A208829-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A208829-004 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A208829-005 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A208829-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A208829-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A208829-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A208829-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A208829-005 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A208829-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A208829-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A208829-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A208829-004 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A208829-005 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A208829-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A208829-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A208829-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A208829-004 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A208829-005 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208829-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208829-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208829-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208829-004 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208829-005 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A208829-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A208829-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A208829-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A208829-004 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A208829-005 | AB | 1 | 5aa47cf7b7d7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
|---|---|---|---|---|---|
| 50090-4657-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-265c-0266-e053-dadaa90a7c1a | Buspirone Hydrochloride Tablets, USP (5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg) Rx only |
| 50090-4657-3 | 2023-01-30 | C162847 | 48780-1 | f386c64a-265c-0266-e053-dadaa90a7c1a | Buspirone Hydrochloride Tablets, USP (5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg) Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4657-1 | busPIRone HCl | 60 in 1 BOTTLE | TABLET | 60 | 6 | |
| 50090-4657-3 | busPIRone HCl | 90 in 1 BOTTLE | TABLET | 90 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-4657-1 | EA - Each | 50090-4657 | 49dfae55-0aee-44a4-a81d-b964afb8f706 | 1 | 2022-12-07 |
| 50090-4657-3 | EA - Each | 50090-4657 | 2084028d-7813-4059-a8ce-5e3c3bd224f2 | 1 | 2022-12-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4657 | BUSPIRONE HCL (BUSPIRONE HYDROCHLORIDE) TABLET [A-S MEDICATION SOLUTIONS] | 6 | Legacy NDC, 2 package rows | 20210615_130fac8c-27e2-4c67-8e03-63062e509992.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866018 | busPIRone HCl 15 MG Oral Tablet | PSN | 130fac8c-27e2-4c67-8e03-63062e509992 | 6 |
| 866018 | buspirone hydrochloride 15 MG Oral Tablet | SCD | 130fac8c-27e2-4c67-8e03-63062e509992 | 6 |
| 866018 | buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet | SY | 130fac8c-27e2-4c67-8e03-63062e509992 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-4657-1 | 50090465701 | 60 TABLET in 1 BOTTLE (50090-4657-1) | 60 tablet | 2019-10-28 | 0000-00-00 | No | No | Current |
| 50090-4657-3 | 50090465703 | 90 TABLET in 1 BOTTLE (50090-4657-3) | 90 tablet | 2019-10-28 | 0000-00-00 | No | No | Current |