Buspirone Hydrochloride
- Product NDC
- 48433-012
- 11-digit product format
- 484330012
- Labeler code
- 48433
- Product ID
- 48433-012_4b433e49-a0b8-2f27-e063-6294a90af1b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buspirone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Safecor Health, LLC
- Application
- ANDA076008
- Marketing category
- ANDA
- Marketing start
- 2026-02-04
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 10 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 table| Ingredient | Strength |
|---|
| BUSPIRONE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 207LT9J9OC |
| Rxcui | 866018, 866083, 866090, 866094 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 48433-012-01 | Buspirone Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 3 |
| 48433-012-20 | Buspirone Hydrochloride | 100 in 1 CARTON | TABLET | 100 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 48433-012-01 | 48433001201 | 1 in 1 BLISTER PACK | | | | | Historical |
| 48433-012-20 | 48433001220 | 100 BLISTER PACK in 1 CARTON (48433-012-20) / 1 TABLET in 1 BLISTER PACK (48433-012-01) | 100 blister pack | 2026-02-04 | No | No | Historical |