Buspirone Hydrochloride
- Product NDC
- 70518-4586
- Requested package NDC
- 70518-4586-0
- 11-digit product format
- 705184586
- Labeler code
- 70518
- Product ID
- 70518-4586_4d65f61c-3cb9-e901-e063-6294a90acbec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buspirone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075388
- Marketing category
- ANDA
- Marketing start
- 2026-03-19
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 5 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075388-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | |
| A075388-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | |
| A075388-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075388-001 | AB |
| A075388-002 | AB |
| A075388-003 | 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 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075388-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-05-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075388-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-05-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075388-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-05-09 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075388-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075388-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075388-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075388-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075388-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075388-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075388-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075388-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075388-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075388-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075388-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075388-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075388-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075388-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075388-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075388-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075388-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075388-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075388-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075388-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075388-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075388-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075388-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075388-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075388-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075388-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075388-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075388-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075388-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075388-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075388-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075388-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075388-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075388-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075388-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075388-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075388-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075388-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075388-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075388-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Buspirone Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUSPIRONE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 207LT9J9OC | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 866094 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8e0219e9-d305-4473-8229-aee0ee84caf6 | 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 |
|---|---|---|---|---|---|---|
| 70518-4586-0 | Buspirone Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
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. | 8e0219e9-d305-4473-8229-aee0ee84caf6 | 2026-03-19 | Warnings, Adverse reactions | 075388 ANDA075388 70518-4586-0 70518-4586 70518458600 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 476f4f55-c6c1-4f39-950e-59236f499577 | 2026-03-18 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 84621631-4c13-4147-ae3c-4ed30d4ebb37 | 2026-03-16 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | 3155e607-bc7f-4e90-9edf-8e862dd5737d | 2026-02-16 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Proficient Rx LP | 1521109d-8386-472f-9483-f1fe9f7ed152 | 2026-01-01 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 338f3317-96c0-4b8a-8299-8ce2a10911ae | 2025-12-02 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | e4d44e49-eb8f-454e-a737-22caf30bda78 | 2025-12-01 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 49659ee7-ca08-4df1-8e6b-3a366a7839c7 | 2025-11-04 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | aba814f0-55ce-4480-99f1-b9ad1ba77d3f | 2025-11-03 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | bee0edbf-3fc3-484b-9715-f13a329216ae | 2025-11-03 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 4e7640d1-0a31-4f97-82bb-574cf1ff6e4a | 2025-10-28 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 40d5813d-d040-002c-e063-6294a90a5f7a | 2025-10-10 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 7c7225a0-8237-4998-843a-bf10fa6ec65b | 2025-10-09 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 2df0b238-14a4-40ca-a235-411f6c9b8338 | 2025-10-06 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | f85b59b7-b945-4440-8378-987bd287a655 | 2025-10-01 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | b217f341-7d51-475d-887f-f16786164c7b | 2025-10-01 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 270398a0-21b8-407b-af76-4aeef90f72be | 2025-10-01 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3dd7f213-afd8-67d6-e063-6294a90ac108 | 2025-09-08 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 65c69118-36bb-4f0d-9669-b52556056ec5 | 2025-09-04 | Warnings, Adverse reactions | 075388 ANDA075388 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | ed7e334a-cc4a-47b2-a4db-56495730b698 | 2025-09-03 | Warnings, Adverse reactions | 075388 ANDA075388 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866094 | busPIRone HCl 5 MG Oral Tablet | PSN | 8e0219e9-d305-4473-8229-aee0ee84caf6 | 1 |
| 866094 | buspirone hydrochloride 5 MG Oral Tablet | SCD | 8e0219e9-d305-4473-8229-aee0ee84caf6 | 1 |
| 866094 | buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet | SY | 8e0219e9-d305-4473-8229-aee0ee84caf6 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-4586-0 | 70518458600 | 30 TABLET in 1 BLISTER PACK (70518-4586-0) | 30 tablet | 2026-03-19 | No | No | Current |