Buspirone hydrochloride
- Product NDC
- 11788-058
- 11-digit product format
- 117880058
- Labeler code
- 11788
- Product ID
- 11788-058_fe9868fd-eb67-48a4-99a3-f25125507e36
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AiPing Pharmaceutical, Inc.
- Application
- ANDA202087
- Marketing category
- ANDA
- Marketing start
- 2025-09-26
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 7.5 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Buspirone hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUSPIRONE HYDROCHLORIDE | 7.5 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 |
|---|---|---|---|---|---|---|
| 11788-058-01 | Buspirone hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 11788-058-01 | EA - Each | 11788-058 | 23e87ae8-33e3-4753-9dd6-a59efe102365 | 1 | 2025-11-13 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866083 | busPIRone HCl 10 MG Oral Tablet | PSN | 55810b17-4796-49d0-90e4-8e075d62eda4 | 1 |
| 866018 | busPIRone HCl 15 MG Oral Tablet | PSN | 55810b17-4796-49d0-90e4-8e075d62eda4 | 1 |
| 866090 | busPIRone HCl 30 MG Oral Tablet | PSN | 55810b17-4796-49d0-90e4-8e075d62eda4 | 1 |
| 866094 | busPIRone HCl 5 MG Oral Tablet | PSN | 55810b17-4796-49d0-90e4-8e075d62eda4 | 1 |
| 866111 | busPIRone HCl 7.5 MG Oral Tablet | PSN | 55810b17-4796-49d0-90e4-8e075d62eda4 | 1 |
| 866083 | buspirone hydrochloride 10 MG Oral Tablet | SCD | 55810b17-4796-49d0-90e4-8e075d62eda4 | 1 |
| 866018 | buspirone hydrochloride 15 MG Oral Tablet | SCD | 55810b17-4796-49d0-90e4-8e075d62eda4 | 1 |
| 866090 | buspirone hydrochloride 30 MG Oral Tablet | SCD | 55810b17-4796-49d0-90e4-8e075d62eda4 | 1 |
| 866094 | buspirone hydrochloride 5 MG Oral Tablet | SCD | 55810b17-4796-49d0-90e4-8e075d62eda4 | 1 |
| 866111 | buspirone hydrochloride 7.5 MG Oral Tablet | SCD | 55810b17-4796-49d0-90e4-8e075d62eda4 | 1 |
| 866083 | buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet | SY | 55810b17-4796-49d0-90e4-8e075d62eda4 | 1 |
| 866111 | buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet | SY | 55810b17-4796-49d0-90e4-8e075d62eda4 | 1 |
| 866018 | buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet | SY | 55810b17-4796-49d0-90e4-8e075d62eda4 | 1 |
| 866090 | buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet | SY | 55810b17-4796-49d0-90e4-8e075d62eda4 | 1 |
| 866094 | buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet | SY | 55810b17-4796-49d0-90e4-8e075d62eda4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 11788-058-01 | 11788005801 | 100 TABLET in 1 BOTTLE (11788-058-01) | 100 tablet | 2025-09-26 | No | No | Historical |