Buspirone Hydrochloride
- Product NDC
- 53808-1102
- 11-digit product format
- 538081102
- Labeler code
- 53808
- Product ID
- 53808-1102_311d2171-f3ad-4cb1-b91d-da7a3d05800c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DOH CENTRAL PHARMACY
- Application
- ANDA202330
- Marketing category
- ANDA
- Marketing start
- 2018-06-29
- Marketing end
- 0000-00-00
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 5 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 | 53808-1102 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 53808-1102 | 53808-1102-1 | 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 | 53808-1102-1 | 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 | 53808-1102-1 | 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 | 53808-1102-1 | 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 | 53808-1102-1 | 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 | 53808-1102-1 | 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 | 53808-1102-1 | 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 | 53808-1102-1 | 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 | 53808-1102-1 | 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 | 53808-1102-1 | 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 | 53808-1102-1 | 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 | 53808-1102-1 | 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 | 53808-1102-1 | 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 | 53808-1102-1 | 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 | 53808-1102-1 | 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 | 53808-1102-1 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202330-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-08-25 | |
| A202330-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-25 | |
| A202330-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-08-25 | |
| A202330-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-08-25 | |
| A202330-005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-02-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202330-001 | AB |
| A202330-002 | AB |
| A202330-003 | AB |
| A202330-004 | AB |
| A202330-005 | 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 | A202330-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-08-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202330-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202330-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-08-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202330-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-08-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202330-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-02-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202330-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202330-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202330-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202330-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202330-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-02-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202330-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-08-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202330-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202330-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-08-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202330-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-08-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202330-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-02-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202330-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202330-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202330-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202330-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202330-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-02-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202330-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202330-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202330-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202330-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202330-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-02-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202330-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-08-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202330-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202330-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-08-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202330-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-08-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202330-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-02-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202330-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-08-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202330-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202330-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-08-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202330-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-08-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202330-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-02-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202330-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-08-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202330-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-08-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202330-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-08-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202330-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-08-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202330-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-02-17 | 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 | A202330-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202330-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202330-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202330-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202330-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202330-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202330-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202330-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202330-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202330-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202330-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202330-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202330-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202330-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202330-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202330-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202330-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202330-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202330-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202330-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202330-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202330-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202330-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202330-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202330-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202330-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202330-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202330-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202330-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202330-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202330-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202330-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202330-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202330-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202330-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202330-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202330-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202330-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202330-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202330-005 | 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 |
|---|---|---|---|---|---|
| 53808-1102-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1cd9-111a-e063-dadaa90a10e2 | Buspirone Hydrochloride Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-1102-1 | Buspirone Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-1102 | BUSPIRONE HYDROCHLORIDE TABLET [DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20190123_94874520-e286-4e2d-87a6-f600b0f96f09.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 | Strides Pharma Inc. | cb0091ad-97f6-431b-b2b9-e03171eed274 | 2026-07-08 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | b42cc365-6259-4d2e-9648-d37718b65e1e | 2026-06-30 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 50b18368-d37c-374b-e063-6394a90a8114 | 2026-04-30 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 093b701d-4a43-4871-b726-c5820fa3ab95 | 2026-04-14 | Warnings, Adverse reactions | 202330 ANDA202330 |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | DIRECT RX | bae98d45-e192-56e3-e053-2a95a90aadc3 | 2026-03-05 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Golden State Medical Supply, Inc. | bcce49d3-c8eb-9f9b-e053-2995a90a67d9 | 2026-02-18 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | ecdfd79e-7450-40ec-9561-cdda3a043990 | 2026-01-28 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 4d1ae09a-3ead-4604-8d13-590f41f63b96 | 2026-01-28 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Northwind Health Company, LLC | d9de7cf1-c38d-8b3c-e053-2995a90aa26b | 2026-01-01 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Strides Pharma Science Limited | cff9f09a-1ea2-4968-b57b-e62bebaae238 | 2025-09-02 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 1790d63d-ecb1-da9d-e063-6294a90a50ba | 2025-08-19 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 63e2d4e2-f1ab-480d-b0bb-79b6cdb57a5d | 2025-05-12 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone HCL | BUSPIRONE HCL | Direct_Rx | f83219c9-8081-fe55-e053-6394a90aa924 | 2025-01-22 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | da6f4a74-a71e-4ccc-af2c-8de29e909c3b | 2024-08-12 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Proficient Rx LP | 24a95296-5fbe-49df-b1fe-4760d3a5ffe1 | 2022-07-01 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 0d46cf24-07e1-4bb7-8b5b-5ce12a030afd | 2022-03-16 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 62e4345a-2c51-4f93-89f0-282895ced785 | 2021-11-08 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | fbab1056-b63e-473e-9259-ba099d884d2b | 2021-10-28 | Warnings, Adverse reactions | 202330 ANDA202330 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | fa8171d4-f73c-4a91-973d-cb46c5507081 | 2021-09-29 | Warnings, Adverse reactions | 202330 ANDA202330 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866094 | busPIRone HCl 5 MG Oral Tablet | PSN | 94874520-e286-4e2d-87a6-f600b0f96f09 | 1 |
| 866094 | buspirone hydrochloride 5 MG Oral Tablet | SCD | 94874520-e286-4e2d-87a6-f600b0f96f09 | 1 |
| 866094 | buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet | SY | 94874520-e286-4e2d-87a6-f600b0f96f09 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53808-1102-1 | 53808110201 | 30 TABLET in 1 BLISTER PACK (53808-1102-1) | 30 tablet | 2018-06-29 | 0000-00-00 | No | No | Current |