Buspirone Hydrochloride
- Product NDC
- 70518-4052
- 11-digit product format
- 705184052
- Labeler code
- 70518
- Product ID
- 70518-4052_54146297-7d4c-dc6e-e063-6394a90a10d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA210907
- Marketing category
- ANDA
- Marketing start
- 2024-04-15
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 15 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 package | package | 70518-4052 | 70518-4052-1 | D | Discontinued by firm | 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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-4052 | 70518-4052-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210907-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | |
| A210907-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | |
| A210907-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 |
| A210907-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210907-001 | AB |
| A210907-002 | AB |
| A210907-003 | AB |
| A210907-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A210907-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210907-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210907-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210907-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A210907-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210907-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210907-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210907-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-004 | AB | 1 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Buspirone Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUSPIRONE HYDROCHLORIDE | 15 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 207LT9J9OC | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 866018 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fbff8248-b73c-474e-907e-449f8316c629 | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-4052-0 | Buspirone Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | 6 | |
| 70518-4052-1 | Buspirone Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | 6 | |
| 70518-4052-2 | Buspirone Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | 6 | |
| 70518-4052-3 | Buspirone Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 6 | |
| 70518-4052-4 | Buspirone Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-4052 | BUSPIRONE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] | 3 | Current NDC, 5 package rows | 20250215_fbff8248-b73c-474e-907e-449f8316c629.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 | REMEDYREPACK INC. | ed2b56fe-e02f-46bc-808a-352f9bbb5b57 | 2026-08-27 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Proficient Rx LP | 801803eb-be17-4064-8813-7ccf52316cde | 2026-08-01 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 544a4570-bd7f-72bb-e063-6394a90ab8d6 | 2026-06-15 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | fbff8248-b73c-474e-907e-449f8316c629 | 2026-06-12 | Warnings, Adverse reactions | 210907 ANDA210907 70518-4052 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Asclemed USA, Inc. | 97f2d082-0931-4e4f-a5be-7792e399e42b | 2026-05-04 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Coupler LLC | 510120d3-c922-a071-e063-6294a90af6a7 | 2026-05-04 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | 5b4da3f8-a5ce-4699-92e1-37fb95e0af2d | 2026-04-23 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | 6c6db7a9-a728-406a-81af-edd89e1cc26f | 2026-04-07 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 824c80e6-d508-405f-8a4f-2f10df5a9dc8 | 2026-03-20 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 187c315b-9c2c-485f-aa63-e399e0796e78 | 2026-03-20 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 068ee1a0-a77a-4803-bad9-18117d7fb358 | 2026-03-20 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 18ddef0b-1451-4bea-94fb-b6ec27f4744b | 2026-01-14 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 48b4e52d-d4c4-4d24-a0ac-24316371cef0 | 2025-09-09 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone HCL | BUSPIRONE HCL | Direct_Rx | 3246dd4d-f787-2f62-e063-6294a90a9cd2 | 2025-06-25 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone HCL | BUSPIRONE HCL | Direct_Rx | 37780596-3b6f-8d00-e063-6294a90ad4ad | 2025-06-13 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 335107c9-5799-c4df-e063-6294a90a5ca0 | 2025-04-21 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | b6352207-e708-44a7-8a63-93b96613e1e7 | 2025-03-27 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 30c93022-4126-db8c-e063-6394a90a7579 | 2025-03-20 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone HCL | BUSPIRONE HCL | Direct_Rx | f71e019b-3928-f8eb-e053-6394a90a871e | 2025-02-28 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | f98d258d-6479-253a-e053-6394a90acbb3 | 2025-02-10 | Warnings, Adverse reactions | 210907 ANDA210907 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866018 | busPIRone HCl 15 MG Oral Tablet | PSN | fbff8248-b73c-474e-907e-449f8316c629 | 6 |
| 866018 | buspirone hydrochloride 15 MG Oral Tablet | SCD | fbff8248-b73c-474e-907e-449f8316c629 | 6 |
| 866018 | buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet | SY | fbff8248-b73c-474e-907e-449f8316c629 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-4052-0 | 70518405200 | 30 TABLET in 1 BLISTER PACK (70518-4052-0) | 30 tablet | 2024-04-15 | No | No | Current |
| 70518-4052-1 | 70518405201 | 60 in 1 BOTTLE, PLASTIC | Historical | ||||
| 70518-4052-2 | 70518405202 | 30 TABLET in 1 BLISTER PACK (70518-4052-2) | 30 tablet | 2025-02-12 | No | No | Current |
| 70518-4052-3 | 70518405203 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4052-3) | 90 tablet | 2025-06-18 | No | No | Current |
| 70518-4052-4 | 70518405204 | 30 TABLET in 1 BOTTLE, PLASTIC (70518-4052-4) | 30 tablet | 2025-11-28 | No | No | Current |