Nebivolol
- Product NDC
- 72603-871
- 11-digit product format
- 726030871
- Labeler code
- 72603
- Product ID
- 72603-871_9a81733f-abb2-4090-a1e1-cbca356821e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nebivolol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA212661
- Marketing category
- ANDA
- Marketing start
- 2025-07-14
- 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 |
|---|---|---|---|---|---|---|
| 72603-871-01 | Nebivolol | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 72603-871-02 | Nebivolol | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72603-871-01 | EA - Each | 72603-871 | 1baf1e88-aff8-4c4b-80b7-2a0e6a3f482c | 1 | 2025-09-12 |
| 72603-871-02 | EA - Each | 72603-871 | ae1f4fbb-9c53-4e69-b03c-5fa6ac7d2cfa | 1 | 2025-09-12 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 751612 | nebivolol 10 MG Oral Tablet | PSN | 9a81733f-abb2-4090-a1e1-cbca356821e8 | 1 |
| 751618 | nebivolol 2.5 MG Oral Tablet | PSN | 9a81733f-abb2-4090-a1e1-cbca356821e8 | 1 |
| 827073 | nebivolol 20 MG Oral Tablet | PSN | 9a81733f-abb2-4090-a1e1-cbca356821e8 | 1 |
| 387013 | nebivolol 5 MG Oral Tablet | PSN | 9a81733f-abb2-4090-a1e1-cbca356821e8 | 1 |
| 751612 | nebivolol 10 MG Oral Tablet | SCD | 9a81733f-abb2-4090-a1e1-cbca356821e8 | 1 |
| 751618 | nebivolol 2.5 MG Oral Tablet | SCD | 9a81733f-abb2-4090-a1e1-cbca356821e8 | 1 |
| 827073 | nebivolol 20 MG Oral Tablet | SCD | 9a81733f-abb2-4090-a1e1-cbca356821e8 | 1 |
| 387013 | nebivolol 5 MG Oral Tablet | SCD | 9a81733f-abb2-4090-a1e1-cbca356821e8 | 1 |
| 751612 | nebivolol (as nebivolol hydrochloride) 10 MG Oral Tablet | SY | 9a81733f-abb2-4090-a1e1-cbca356821e8 | 1 |
| 751618 | nebivolol (as nebivolol hydrochloride) 2.5 MG Oral Tablet | SY | 9a81733f-abb2-4090-a1e1-cbca356821e8 | 1 |
| 827073 | nebivolol (as nebivolol hydrochloride) 20 MG Oral Tablet | SY | 9a81733f-abb2-4090-a1e1-cbca356821e8 | 1 |
| 387013 | nebivolol (as nebivolol hydrochloride) 5 MG Oral Tablet | SY | 9a81733f-abb2-4090-a1e1-cbca356821e8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72603-871-01 | 72603087101 | 30 TABLET in 1 BOTTLE (72603-871-01) | 30 tablet | 2025-07-14 | No | No | Historical |
| 72603-871-02 | 72603087102 | 90 TABLET in 1 BOTTLE (72603-871-02) | 90 tablet | 2025-07-14 | No | No | Historical |