Buspirone Hydrochloride
- Product NDC
- 75834-269
- 11-digit product format
- 758340269
- Labeler code
- 75834
- Product ID
- 75834-269_5bad7053-8f63-45fc-adb0-88c628fa039b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buspirone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Nivagen Pharmaceuticals Inc.
- Application
- ANDA209696
- Marketing category
- ANDA
- Marketing start
- 2021-02-15
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 15 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 table| Ingredient | Strength |
|---|
| BUSPIRONE HYDROCHLORIDE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 207LT9J9OC |
| Rxcui | 866018, 866083, 866090, 866094, 866111 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75834-269-01 | Buspirone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 75834-269-05 | Buspirone Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
| 75834-269-60 | Buspirone Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-269 | BUSPIRONE HYDROCHLORIDE TABLET [NIVAGEN PHARMACEUTICALS INC.] | 1 | Current NDC, Legacy NDC, 3 package rows | 20210227_b08dd2e7-e808-4b51-b404-5009076b82eb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75834-269-01 | 75834026901 | 100 TABLET in 1 BOTTLE (75834-269-01) | 100 tablet | 2021-02-15 | 0000-00-00 | No | No | Current |
| 75834-269-05 | 75834026905 | 500 TABLET in 1 BOTTLE (75834-269-05) | 500 tablet | 2021-02-15 | 0000-00-00 | No | No | Current |
| 75834-269-60 | 75834026960 | 60 TABLET in 1 BOTTLE (75834-269-60) | 60 tablet | 2021-02-15 | 0000-00-00 | No | No | Current |