Nebivolol
- Product NDC
- 71209-058
- 11-digit product format
- 712090058
- Labeler code
- 71209
- Product ID
- 71209-058_0ab335f1-2089-496b-b65f-02c697f6ee89
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nebivolol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cadila Pharmaceuticals Limited
- Application
- ANDA208717
- Marketing category
- ANDA
- Marketing start
- 2017-12-29
- 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 |
|---|
| 71209-058-01 | Nebivolol | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
| 71209-058-04 | Nebivolol | 90 in 1 BOTTLE | TABLET | 90 | | 7 |
| 71209-058-05 | Nebivolol | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 71209-058-11 | Nebivolol | 1000 in 1 BOTTLE | TABLET | 1000 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71209-058 | NEBIVOLOL TABLET [CADILA PHARMACEUTICALS LIMITED] | 7 | Current NDC, Legacy NDC, 4 package rows | 20231110_451cdd6e-13b4-402f-8a44-cdf5f7433a49.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 |
|---|
| 71209-058-01 | 71209005801 | 30 TABLET in 1 BOTTLE (71209-058-01) | 30 tablet | 2018-10-16 | 0000-00-00 | No | No | Current |
| 71209-058-04 | 71209005804 | 90 TABLET in 1 BOTTLE (71209-058-04) | 90 tablet | 2018-10-16 | 0000-00-00 | No | No | Current |
| 71209-058-05 | 71209005805 | 100 TABLET in 1 BOTTLE (71209-058-05) | 100 tablet | 2018-10-16 | 0000-00-00 | No | No | Current |
| 71209-058-11 | 71209005811 | 1000 TABLET in 1 BOTTLE (71209-058-11) | 1000 tablet | 2018-10-16 | 0000-00-00 | No | No | Current |