Buspirone Hydrochloride
- Product NDC
- 64980-650
- 11-digit product format
- 649800650
- Labeler code
- 64980
- Product ID
- 64980-650_66cf8d73-ea13-47fe-be0f-45edd9101d2d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA075413
- Marketing category
- ANDA
- Marketing start
- 2026-02-27
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 5 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 Identifiers#
| Field | Values |
|---|---|
| Unii | 207LT9J9OC |
| Rxcui | 866018, 866083, 866090, 866094, 866111 |
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 |
|---|---|---|---|---|---|---|
| 64980-650-01 | Buspirone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 64980-650-06 | Buspirone Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 64980-650-50 | Buspirone Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866083 | busPIRone HCl 10 MG Oral Tablet | PSN | b9aa144c-cb36-4069-9eaa-7c150298cdd7 | 1 |
| 866018 | busPIRone HCl 15 MG Oral Tablet | PSN | b9aa144c-cb36-4069-9eaa-7c150298cdd7 | 1 |
| 866090 | busPIRone HCl 30 MG Oral Tablet | PSN | b9aa144c-cb36-4069-9eaa-7c150298cdd7 | 1 |
| 866094 | busPIRone HCl 5 MG Oral Tablet | PSN | b9aa144c-cb36-4069-9eaa-7c150298cdd7 | 1 |
| 866111 | busPIRone HCl 7.5 MG Oral Tablet | PSN | b9aa144c-cb36-4069-9eaa-7c150298cdd7 | 1 |
| 866083 | buspirone hydrochloride 10 MG Oral Tablet | SCD | b9aa144c-cb36-4069-9eaa-7c150298cdd7 | 1 |
| 866018 | buspirone hydrochloride 15 MG Oral Tablet | SCD | b9aa144c-cb36-4069-9eaa-7c150298cdd7 | 1 |
| 866090 | buspirone hydrochloride 30 MG Oral Tablet | SCD | b9aa144c-cb36-4069-9eaa-7c150298cdd7 | 1 |
| 866094 | buspirone hydrochloride 5 MG Oral Tablet | SCD | b9aa144c-cb36-4069-9eaa-7c150298cdd7 | 1 |
| 866111 | buspirone hydrochloride 7.5 MG Oral Tablet | SCD | b9aa144c-cb36-4069-9eaa-7c150298cdd7 | 1 |
| 866083 | buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet | SY | b9aa144c-cb36-4069-9eaa-7c150298cdd7 | 1 |
| 866111 | buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet | SY | b9aa144c-cb36-4069-9eaa-7c150298cdd7 | 1 |
| 866018 | buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet | SY | b9aa144c-cb36-4069-9eaa-7c150298cdd7 | 1 |
| 866090 | buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet | SY | b9aa144c-cb36-4069-9eaa-7c150298cdd7 | 1 |
| 866094 | buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet | SY | b9aa144c-cb36-4069-9eaa-7c150298cdd7 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 64980-650-01 | 64980065001 | 100 TABLET in 1 BOTTLE (64980-650-01) | 100 tablet | 2026-02-27 | No | No | Current |
| 64980-650-06 | 64980065006 | 60 TABLET in 1 BOTTLE (64980-650-06) | 60 tablet | 2026-02-27 | No | No | Current |
| 64980-650-50 | 64980065050 | 500 TABLET in 1 BOTTLE (64980-650-50) | 500 tablet | 2026-02-27 | No | No | Current |