BUSPIRONE HYDROCHLORIDE
- Product NDC
- 59651-389
- 11-digit product format
- 596510389
- Labeler code
- 59651
- Product ID
- 59651-389_270d4008-311a-4f5c-905e-95f14bd9f700
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUSPIRONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA078246
- Marketing category
- ANDA
- Marketing start
- 2020-02-21
- Substance
- BUSPIRONE HYDROCHLORIDE
- Active strength
- 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 table| Ingredient | Strength |
|---|
| BUSPIRONE HYDROCHLORIDE | 5 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 |
|---|
| 59651-389-01 | BUSPIRONE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 59651-389-05 | BUSPIRONE HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
| 59651-389-10 | BUSPIRONE HYDROCHLORIDE | 10 in 1 BLISTER PACK | TABLET | 10 | | 2 |
| 59651-389-10 | BUSPIRONE HYDROCHLORIDE | 10 in 1 CARTON | TABLET | 10 | | 2 |
| 59651-389-30 | BUSPIRONE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 59651-389-60 | BUSPIRONE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-389 | BUSPIRONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, Legacy NDC, 6 package rows | 20210706_05c006d2-44b9-431f-bce2-aff09c043ecb.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 |
|---|
| 59651-389-01 | 59651038901 | 100 TABLET in 1 BOTTLE (59651-389-01) | 100 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 59651-389-05 | 59651038905 | 500 TABLET in 1 BOTTLE (59651-389-05) | 500 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 59651-389-10 | 59651038910 | 10 BLISTER PACK in 1 CARTON (59651-389-10) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2020-02-21 | 0000-00-00 | No | No | Current |
| 59651-389-30 | 59651038930 | 30 TABLET in 1 BOTTLE (59651-389-30) | 30 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |
| 59651-389-60 | 59651038960 | 60 TABLET in 1 BOTTLE (59651-389-60) | 60 tablet | 2020-02-21 | 0000-00-00 | No | No | Current |