Buspirone Hydrochloride
- Product NDC
- 68788-8681
- 11-digit product format
- 687888681
- Labeler code
- 68788
- Product ID
- 68788-8681_ae5886ab-b496-4cc8-8792-9eba4b48d6b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA210907
- Marketing category
- ANDA
- Marketing start
- 2024-06-01
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 15 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 68788-8681_ae5886ab-b496-4cc8-8792-9eba4b48d6b7
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Buspirone Hydrochloride
- Generic name
- Buspirone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2024-06-01
- Marketing category
- ANDA
- Application number
- ANDA210907
- Listing expiration
- 2027-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| BUSPIRONE HYDROCHLORIDE | 15 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 207LT9J9OC |
| Rxcui | 866018 |
| Spl Set Id | 187c315b-9c2c-485f-aa63-e399e0796e78 |
| Manufacturer Name | Preferred Pharmaceuticals Inc. |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 207LT9J9OC | BUSPIRONE HYDROCHLORIDE | 33386-08-2 | BUSPIRONE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8681-1 | 68788868101 | 100 TABLET in 1 BOTTLE, PLASTIC (68788-8681-1) | 100 tablet | 2024-06-01 | No | No | Current |
| 68788-8681-3 | 68788868103 | 30 TABLET in 1 BOTTLE, PLASTIC (68788-8681-3) | 30 tablet | 2024-06-01 | No | No | Current |
| 68788-8681-6 | 68788868106 | 60 TABLET in 1 BOTTLE, PLASTIC (68788-8681-6) | 60 tablet | 2024-06-01 | No | No | Current |
| 68788-8681-9 | 68788868109 | 90 TABLET in 1 BOTTLE, PLASTIC (68788-8681-9) | 90 tablet | 2024-06-01 | No | No | Current |