Nebivolol
- Product NDC
- 31722-586
- 11-digit product format
- 317220586
- Labeler code
- 31722
- Product ID
- 31722-586_103af555-44dd-5dfb-e063-6294a90a259f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nebivolol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA203825
- Marketing category
- ANDA
- Marketing start
- 2021-09-17
- Substance
- NEBIVOLOL HYDROCHLORIDE
- Active strength
- 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 |
|---|---|
| NEBIVOLOL HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | JGS34J7L9I |
| Rxcui | 387013, 751612, 751618, 827073 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b9af42fa-00cc-b314-02ce-e06da0a12313 | Product name | 6 | 20250423 |
| 52311e76-a520-4bd2-9d5b-e0b6d6f44519 | Product name | 2 | 20231208 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 31722-586-01 | Nebivolol | 100 in 1 BOTTLE | TABLET | 100 | 2 | |
| 31722-586-30 | Nebivolol | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 31722-586-31 | Nebivolol | 10 in 1 BLISTER PACK | TABLET | 10 | 2 | |
| 31722-586-32 | Nebivolol | 10 in 1 CARTON | TABLET | 10 | 2 | |
| 31722-586-33 | Nebivolol | 7 in 1 BLISTER PACK | TABLET | 7 | 2 | |
| 31722-586-34 | Nebivolol | 18 in 1 CARTON | TABLET | 18 | 2 | |
| 31722-586-90 | Nebivolol | 90 in 1 BOTTLE | TABLET | 90 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 31722-586-30 | EA - Each | 31722-586 | e875a948-ef9e-408e-be8f-21c382b29506 | 1 | 2021-10-08 |
| 31722-586-90 | EA - Each | 31722-586 | 76b86698-198c-4f8a-9ba3-ed2e946f7d28 | 1 | 2021-10-08 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 751612 | nebivolol 10 MG Oral Tablet | PSN | 202d5142-6180-4d48-9a9f-1bd6992fc49b | 2 |
| 751618 | nebivolol 2.5 MG Oral Tablet | PSN | 202d5142-6180-4d48-9a9f-1bd6992fc49b | 2 |
| 827073 | nebivolol 20 MG Oral Tablet | PSN | 202d5142-6180-4d48-9a9f-1bd6992fc49b | 2 |
| 387013 | nebivolol 5 MG Oral Tablet | PSN | 202d5142-6180-4d48-9a9f-1bd6992fc49b | 2 |
| 751612 | nebivolol 10 MG Oral Tablet | SCD | 202d5142-6180-4d48-9a9f-1bd6992fc49b | 2 |
| 751618 | nebivolol 2.5 MG Oral Tablet | SCD | 202d5142-6180-4d48-9a9f-1bd6992fc49b | 2 |
| 827073 | nebivolol 20 MG Oral Tablet | SCD | 202d5142-6180-4d48-9a9f-1bd6992fc49b | 2 |
| 387013 | nebivolol 5 MG Oral Tablet | SCD | 202d5142-6180-4d48-9a9f-1bd6992fc49b | 2 |
| 751612 | nebivolol (as nebivolol hydrochloride) 10 MG Oral Tablet | SY | 202d5142-6180-4d48-9a9f-1bd6992fc49b | 2 |
| 751618 | nebivolol (as nebivolol hydrochloride) 2.5 MG Oral Tablet | SY | 202d5142-6180-4d48-9a9f-1bd6992fc49b | 2 |
| 827073 | nebivolol (as nebivolol hydrochloride) 20 MG Oral Tablet | SY | 202d5142-6180-4d48-9a9f-1bd6992fc49b | 2 |
| 387013 | nebivolol (as nebivolol hydrochloride) 5 MG Oral Tablet | SY | 202d5142-6180-4d48-9a9f-1bd6992fc49b | 2 |
| 387013 | nebivolol 5 MG Oral Tablet | PSN | 90d4ea48-7831-4cb0-8796-1ed79407c363 | 1 |
| 387013 | nebivolol 5 MG Oral Tablet | PSN | 9f0bd0b4-ee17-46bb-b4e2-8ca0ea0e0489 | 1 |
| 387013 | nebivolol 5 MG Oral Tablet | PSN | c6606db5-3937-4e90-9870-3cbfa4ec909e | 1 |
| 387013 | nebivolol 5 MG Oral Tablet | SCD | 90d4ea48-7831-4cb0-8796-1ed79407c363 | 1 |
| 387013 | nebivolol 5 MG Oral Tablet | SCD | 9f0bd0b4-ee17-46bb-b4e2-8ca0ea0e0489 | 1 |
| 387013 | nebivolol 5 MG Oral Tablet | SCD | c6606db5-3937-4e90-9870-3cbfa4ec909e | 1 |
| 387013 | nebivolol (as nebivolol hydrochloride) 5 MG Oral Tablet | SY | 90d4ea48-7831-4cb0-8796-1ed79407c363 | 1 |
| 387013 | nebivolol (as nebivolol hydrochloride) 5 MG Oral Tablet | SY | 9f0bd0b4-ee17-46bb-b4e2-8ca0ea0e0489 | 1 |
| 387013 | nebivolol (as nebivolol hydrochloride) 5 MG Oral Tablet | SY | c6606db5-3937-4e90-9870-3cbfa4ec909e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 31722-586-01 | 31722058601 | 100 TABLET in 1 BOTTLE (31722-586-01) | 100 tablet | 2021-09-17 | 0000-00-00 | No | No | Current |
| 31722-586-30 | 31722058630 | 30 TABLET in 1 BOTTLE (31722-586-30) | 30 tablet | 2021-09-17 | 0000-00-00 | No | No | Current |
| 31722-586-31 | 31722058631 | 10 in 1 BLISTER PACK | Historical | |||||
| 31722-586-32 | 31722058632 | 10 BLISTER PACK in 1 CARTON (31722-586-32) / 10 TABLET in 1 BLISTER PACK (31722-586-31) | 10 blister pack | 2021-09-17 | 0000-00-00 | No | No | Current |
| 31722-586-33 | 31722058633 | 7 in 1 BLISTER PACK | Historical | |||||
| 31722-586-34 | 31722058634 | 18 BLISTER PACK in 1 CARTON (31722-586-34) / 7 TABLET in 1 BLISTER PACK (31722-586-33) | 18 blister pack | 2021-09-17 | 0000-00-00 | No | No | Current |
| 31722-586-90 | 31722058690 | 90 TABLET in 1 BOTTLE (31722-586-90) | 90 tablet | 2021-09-17 | 0000-00-00 | No | No | Current |