Buspirone Hydrochloride
- Product NDC
- 16729-200
- 11-digit product format
- 167290200
- Labeler code
- 16729
- Product ID
- 16729-200_4092e48b-b3d6-abf3-e063-6394a90afe61
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA202557
- Marketing category
- ANDA
- Marketing start
- 2016-12-15
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 5 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202557-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | |
| A202557-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | |
| A202557-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | |
| A202557-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-12-30 | |
| A202557-005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202557-001 | AB |
| A202557-002 | AB |
| A202557-003 | AB |
| A202557-004 | AB |
| A202557-005 | 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 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2014-12-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2014-12-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2014-12-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2014-12-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2014-12-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202557-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-005 | AB | 1 | 5bbf6a4d5a75… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Buspirone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUSPIRONE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 207LT9J9OC | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3da22999-f5fb-49fd-acde-c3006598e985 | 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 |
|---|---|---|---|---|---|---|
| 16729-200-01 | Buspirone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 13 | |
| 16729-200-16 | Buspirone Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | 13 | |
| 16729-200-17 | Buspirone Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16729-200-01 | EA - Each | 16729-200 | 41a09d80-dec4-4d42-8bfb-77b3a51c7ae6 | 1 | 2016-12-07 |
| 16729-200-16 | EA - Each | 16729-200 | 63ff7837-df75-4012-9b93-dbc1adb345a1 | 1 | 2016-12-07 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BUSPIRONE HYDROCHLORIDE | ACTIVE INGREDIENT | 207LT9J9OC | BUSPIRONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.] | 2 | |
| BUSPIRONE | ACTIVE MOIETY | TK65WKS8HL | BUSPIRONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BUSPIRONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BUSPIRONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BUSPIRONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUSPIRONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BUSPIRONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE INC.] | 2 |
DailyMed Dashboard NDC Coverage#
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 | Bryant Ranch Prepack | 66df7f74-5dea-46d6-9ef8-9bab37baf407 | 2026-05-14 | Warnings, Adverse reactions | 202557 ANDA202557 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7db10b76-4520-496e-b450-66a662cc95f6 | 2026-03-18 | Warnings, Adverse reactions | 202557 ANDA202557 |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | DIRECT RX | bae98d45-e192-56e3-e053-2a95a90aadc3 | 2026-03-05 | Warnings, Adverse reactions | 202557 ANDA202557 |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Direct_Rx | 8e9c0553-c994-f54a-e053-2a95a90a6fa3 | 2026-01-08 | Warnings, Adverse reactions | 202557 ANDA202557 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Northwind Health Company, LLC | f318ba7b-121f-2e4f-e053-2a95a90a60c5 | 2026-01-01 | Warnings, Adverse reactions | 202557 ANDA202557 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Accord Healthcare Inc. | 3da22999-f5fb-49fd-acde-c3006598e985 | 2025-10-07 | Warnings, Adverse reactions | 202557 ANDA202557 16729-200 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 540e9b7e-09ff-2cca-e054-00144ff8d46c | 2024-07-09 | Warnings, Adverse reactions | 202557 ANDA202557 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 4ae45cb1-8612-4006-b12c-2440160132ac | 2023-02-06 | Warnings, Adverse reactions | 202557 ANDA202557 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | fac49d42-7bc0-435f-bce2-2548dcdd6de6 | 2018-12-20 | Warnings, Adverse reactions | 202557 ANDA202557 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 8b6e7ae6-5b83-4a5a-ab45-cf4be4287d78 | 2018-10-18 | Warnings, Adverse reactions | 202557 ANDA202557 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866083 | busPIRone HCl 10 MG Oral Tablet | PSN | 3da22999-f5fb-49fd-acde-c3006598e985 | 13 |
| 866018 | busPIRone HCl 15 MG Oral Tablet | PSN | 3da22999-f5fb-49fd-acde-c3006598e985 | 13 |
| 866090 | busPIRone HCl 30 MG Oral Tablet | PSN | 3da22999-f5fb-49fd-acde-c3006598e985 | 13 |
| 866094 | busPIRone HCl 5 MG Oral Tablet | PSN | 3da22999-f5fb-49fd-acde-c3006598e985 | 13 |
| 866111 | busPIRone HCl 7.5 MG Oral Tablet | PSN | 3da22999-f5fb-49fd-acde-c3006598e985 | 13 |
| 866083 | buspirone hydrochloride 10 MG Oral Tablet | SCD | 3da22999-f5fb-49fd-acde-c3006598e985 | 13 |
| 866018 | buspirone hydrochloride 15 MG Oral Tablet | SCD | 3da22999-f5fb-49fd-acde-c3006598e985 | 13 |
| 866090 | buspirone hydrochloride 30 MG Oral Tablet | SCD | 3da22999-f5fb-49fd-acde-c3006598e985 | 13 |
| 866094 | buspirone hydrochloride 5 MG Oral Tablet | SCD | 3da22999-f5fb-49fd-acde-c3006598e985 | 13 |
| 866111 | buspirone hydrochloride 7.5 MG Oral Tablet | SCD | 3da22999-f5fb-49fd-acde-c3006598e985 | 13 |
| 866083 | buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet | SY | 3da22999-f5fb-49fd-acde-c3006598e985 | 13 |
| 866111 | buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet | SY | 3da22999-f5fb-49fd-acde-c3006598e985 | 13 |
| 866018 | buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet | SY | 3da22999-f5fb-49fd-acde-c3006598e985 | 13 |
| 866090 | buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet | SY | 3da22999-f5fb-49fd-acde-c3006598e985 | 13 |
| 866094 | buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet | SY | 3da22999-f5fb-49fd-acde-c3006598e985 | 13 |
| 866094 | busPIRone HCl 5 MG Oral Tablet | PSN | 8e9c0553-c994-f54a-e053-2a95a90a6fa3 | 5 |
| 866094 | buspirone hydrochloride 5 MG Oral Tablet | SCD | 8e9c0553-c994-f54a-e053-2a95a90a6fa3 | 5 |
| 866094 | buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet | SY | 8e9c0553-c994-f54a-e053-2a95a90a6fa3 | 5 |
| 866094 | busPIRone HCl 5 MG Oral Tablet | PSN | 8b6e7ae6-5b83-4a5a-ab45-cf4be4287d78 | 1 |
| 866094 | busPIRone HCl 5 MG Oral Tablet | PSN | 8e85d869-fe78-3148-e053-2995a90a207c | 1 |
| 866094 | busPIRone HCl 5 MG Oral Tablet | PSN | 4f5855b7-d3d4-3477-e054-00144ff8d46c | 1 |
| 866094 | buspirone hydrochloride 5 MG Oral Tablet | SCD | 4f5855b7-d3d4-3477-e054-00144ff8d46c | 1 |
| 866094 | buspirone hydrochloride 5 MG Oral Tablet | SCD | 8b6e7ae6-5b83-4a5a-ab45-cf4be4287d78 | 1 |
| 866094 | buspirone hydrochloride 5 MG Oral Tablet | SCD | 8e85d869-fe78-3148-e053-2995a90a207c | 1 |
| 866094 | buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet | SY | 4f5855b7-d3d4-3477-e054-00144ff8d46c | 1 |
| 866094 | buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet | SY | 8b6e7ae6-5b83-4a5a-ab45-cf4be4287d78 | 1 |
| 866094 | buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet | SY | 8e85d869-fe78-3148-e053-2995a90a207c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16729-200-01 | 16729020001 | 100 TABLET in 1 BOTTLE (16729-200-01) | 100 tablet | 2016-12-15 | 0000-00-00 | No | No | Current |
| 16729-200-16 | 16729020016 | 500 TABLET in 1 BOTTLE (16729-200-16) | 500 tablet | 2016-12-15 | 0000-00-00 | No | No | Current |
| 16729-200-17 | 16729020017 | 1000 TABLET in 1 BOTTLE (16729-200-17) | 1000 tablet | 2020-01-01 | 0000-00-00 | No | No | Current |