Buspirone hydrochloride
- Product NDC
- 69117-0043
- 11-digit product format
- 691170043
- Labeler code
- 69117
- Product ID
- 69117-0043_f16635a5-7e1a-534a-e053-2995a90a9355
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Yiling Pharmaceutical, Inc.
- Application
- ANDA202087
- Marketing category
- ANDA
- Marketing start
- 2019-10-30
- Marketing end
- 0000-00-00
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 30 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2024-12-31
- 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 | 69117-0043 | I | Inactivated by FDA | 2026-08-07 | ||
| excluded package | package | 69117-0043 | 69117-0043-1 | I | Inactivated by FDA | 2026-08-07 | |
| excluded package | package | 69117-0043 | 69117-0043-2 | I | Inactivated by FDA | 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69117-0043-2 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69117-0043-1 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 69117-0043-2 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 69117-0043-1 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 69117-0043-2 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 69117-0043-1 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 69117-0043-2 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 69117-0043-1 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 69117-0043-2 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 69117-0043-1 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 69117-0043-2 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 69117-0043-1 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 69117-0043-1 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 69117-0043-2 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 69117-0043-1 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 69117-0043-2 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 69117-0043-1 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 69117-0043-2 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202087-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-12-16 | |
| A202087-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-12-16 | |
| A202087-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-12-16 | |
| A202087-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-12-16 | |
| A202087-005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2025-07-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202087-001 | AB |
| A202087-002 | AB |
| A202087-003 | AB |
| A202087-004 | AB |
| A202087-005 | 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 | A202087-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-12-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202087-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-12-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202087-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-12-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202087-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-12-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202087-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2025-07-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202087-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-12-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202087-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-12-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202087-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-12-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202087-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-12-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202087-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2025-07-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202087-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-12-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202087-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-12-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202087-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-12-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202087-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-12-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202087-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2025-07-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202087-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-12-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202087-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-12-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202087-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-12-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202087-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-12-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202087-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-12-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202087-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-12-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202087-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-12-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202087-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-12-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202087-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-12-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202087-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-12-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202087-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-12-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202087-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-12-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202087-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-12-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202087-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-12-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202087-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-12-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202087-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-12-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202087-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-12-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202087-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-12-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202087-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-12-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202087-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-12-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202087-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-12-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202087-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-12-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202087-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-12-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202087-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-12-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202087-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-12-16 | 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 | A202087-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202087-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202087-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202087-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202087-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202087-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202087-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202087-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202087-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202087-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202087-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202087-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202087-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202087-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202087-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202087-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202087-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202087-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202087-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202087-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202087-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202087-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202087-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202087-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202087-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202087-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202087-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202087-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202087-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202087-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202087-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202087-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202087-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202087-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202087-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202087-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202087-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202087-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202087-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202087-001 | AB | 1 | d06236e962d9… |
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 |
|---|---|---|---|---|---|
| 69117-0043-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-66a8-d83d-e063-dadaa90ab31f | BUSPIRONE HYDROCHLORIDE TABLETS, USP (Patient Instruction Sheet Included) Rx only |
| 69117-0043-2 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-66a8-d83d-e063-dadaa90ab31f | BUSPIRONE HYDROCHLORIDE TABLETS, USP (Patient Instruction Sheet Included) Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69117-0043-1 | Buspirone hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 4 | |
| 69117-0043-2 | Buspirone hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69117-0043-1 | EA - Each | 69117-0043 | 8576a40b-cbf1-432c-b05b-72af5dde3238 | 1 | 2020-04-20 |
| 69117-0043-2 | EA - Each | 69117-0043 | 37920060-3953-4aa4-8950-39b463e173a3 | 1 | 2020-04-20 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69117-0043 | BUSPIRONE HYDROCHLORIDE TABLET [YILING PHARMACEUTICAL, INC.] | 4 | Legacy NDC, 2 package rows | 20230105_ff9cd082-e9e0-4f89-8b0f-8cbb20941408.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 | AiPing Pharmaceutical, Inc. | 55810b17-4796-49d0-90e4-8e075d62eda4 | 2026-07-29 | Warnings, Adverse reactions | 202087 ANDA202087 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 7b222cb0-0061-4a3e-9d0f-e9f120e7f5d9 | 2026-07-24 | Warnings, Adverse reactions | 202087 ANDA202087 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 427ad27e-6664-afee-e063-6394a90a1890 | 2026-01-08 | Warnings, Adverse reactions | 202087 ANDA202087 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 45c637b7-3057-ea38-e063-6394a90a87b6 | 2025-12-12 | Warnings, Adverse reactions | 202087 ANDA202087 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 424d81f0-b195-5bc2-e063-6394a90a2104 | 2025-12-10 | Warnings, Adverse reactions | 202087 ANDA202087 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Radha Pharmaceuticals, Inc. | 3f66a3fe-9d73-180c-e063-6394a90aacca | 2025-09-22 | Warnings, Adverse reactions | 202087 ANDA202087 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | EPIC PHARMA, LLC | e8f43c66-f8de-419f-9ea9-43ddc4ec0798 | 2025-01-07 | Warnings, Adverse reactions | 202087 ANDA202087 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866083 | busPIRone HCl 10 MG Oral Tablet | PSN | ff9cd082-e9e0-4f89-8b0f-8cbb20941408 | 4 |
| 866018 | busPIRone HCl 15 MG Oral Tablet | PSN | ff9cd082-e9e0-4f89-8b0f-8cbb20941408 | 4 |
| 866090 | busPIRone HCl 30 MG Oral Tablet | PSN | ff9cd082-e9e0-4f89-8b0f-8cbb20941408 | 4 |
| 866094 | busPIRone HCl 5 MG Oral Tablet | PSN | ff9cd082-e9e0-4f89-8b0f-8cbb20941408 | 4 |
| 866083 | buspirone hydrochloride 10 MG Oral Tablet | SCD | ff9cd082-e9e0-4f89-8b0f-8cbb20941408 | 4 |
| 866018 | buspirone hydrochloride 15 MG Oral Tablet | SCD | ff9cd082-e9e0-4f89-8b0f-8cbb20941408 | 4 |
| 866090 | buspirone hydrochloride 30 MG Oral Tablet | SCD | ff9cd082-e9e0-4f89-8b0f-8cbb20941408 | 4 |
| 866094 | buspirone hydrochloride 5 MG Oral Tablet | SCD | ff9cd082-e9e0-4f89-8b0f-8cbb20941408 | 4 |
| 866083 | buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet | SY | ff9cd082-e9e0-4f89-8b0f-8cbb20941408 | 4 |
| 866018 | buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet | SY | ff9cd082-e9e0-4f89-8b0f-8cbb20941408 | 4 |
| 866090 | buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet | SY | ff9cd082-e9e0-4f89-8b0f-8cbb20941408 | 4 |
| 866094 | buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet | SY | ff9cd082-e9e0-4f89-8b0f-8cbb20941408 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69117-0043-1 | 69117004301 | 60 TABLET in 1 BOTTLE (69117-0043-1) | 60 tablet | 2019-10-30 | 0000-00-00 | No | No | Current |
| 69117-0043-2 | 69117004302 | 500 TABLET in 1 BOTTLE (69117-0043-2) | 500 tablet | 2019-10-30 | 0000-00-00 | No | No | Current |