nebivolol
- Product NDC
- 68462-615
- 11-digit product format
- 684620615
- Labeler code
- 68462
- Product ID
- 68462-615_151f00ae-13ed-4174-bf4d-bc30f1fb9d69
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nebivolol hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA203821
- Marketing category
- ANDA
- Marketing start
- 2017-05-25
- Substance
- NEBIVOLOL HYDROCHLORIDE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- nebivolol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NEBIVOLOL HYDROCHLORIDE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JGS34J7L9I |
| Rxcui | 387013, 751612, 751618, 827073 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-615-01 | nebivolol | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 68462-615-11 | nebivolol | 10 in 1 CARTON | TABLET | 10 | | 2 |
| 68462-615-11 | nebivolol | 10 in 1 BLISTER PACK | TABLET | 10 | | 2 |
| 68462-615-30 | nebivolol | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-615 | NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE) TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 2 | Current NDC, Legacy NDC, 4 package rows | 20230808_cb47560d-9e35-4b0f-b12b-6ea478684a5b.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 |
|---|
| 68462-615-01 | 68462061501 | 100 TABLET in 1 BOTTLE (68462-615-01) | 100 tablet | 2017-05-25 | 0000-00-00 | No | No | Current |
| 68462-615-11 | 68462061511 | 10 BLISTER PACK in 1 CARTON (68462-615-11) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2017-05-25 | 0000-00-00 | No | No | Current |
| 68462-615-30 | 68462061530 | 30 TABLET in 1 BOTTLE (68462-615-30) | 30 tablet | 2017-05-25 | 0000-00-00 | No | No | Current |