Nebivolol
- Product NDC
- 27241-179
- 11-digit product format
- 272410179
- Labeler code
- 27241
- Product ID
- 27241-179_4c94e072-38a5-49ca-98ac-90a6319f614d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nebivolol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ajanta Pharma USA Inc.
- Application
- ANDA213349
- Marketing category
- ANDA
- Marketing start
- 2022-03-31
- Marketing end
- 0000-00-00
- Substance
- NEBIVOLOL HYDROCHLORIDE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 27241-179-30 | 2026-01-29 | C162847 | 48780-1 | 49896155-bdd7-586f-e063-e6dba90add90 | These highlights do not include all the information needed to use NEBIVOLOL TABLETS safely and effectively. See full prescribing information for NEBIVOLOL TABLETS. NEBIVOLOL tablets, for oral use Initial U.S. Approval: 2007 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 27241-179-30 | Nebivolol | 30 in 1 BOTTLE | TABLET | 30 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 751612 | nebivolol 10 MG Oral Tablet | PSN | 375f239f-58a7-496b-b0ce-dbacf4b82757 | 4 |
| 751618 | nebivolol 2.5 MG Oral Tablet | PSN | 375f239f-58a7-496b-b0ce-dbacf4b82757 | 4 |
| 827073 | nebivolol 20 MG Oral Tablet | PSN | 375f239f-58a7-496b-b0ce-dbacf4b82757 | 4 |
| 387013 | nebivolol 5 MG Oral Tablet | PSN | 375f239f-58a7-496b-b0ce-dbacf4b82757 | 4 |
| 751612 | nebivolol 10 MG Oral Tablet | SCD | 375f239f-58a7-496b-b0ce-dbacf4b82757 | 4 |
| 751618 | nebivolol 2.5 MG Oral Tablet | SCD | 375f239f-58a7-496b-b0ce-dbacf4b82757 | 4 |
| 827073 | nebivolol 20 MG Oral Tablet | SCD | 375f239f-58a7-496b-b0ce-dbacf4b82757 | 4 |
| 387013 | nebivolol 5 MG Oral Tablet | SCD | 375f239f-58a7-496b-b0ce-dbacf4b82757 | 4 |
| 751612 | nebivolol (as nebivolol hydrochloride) 10 MG Oral Tablet | SY | 375f239f-58a7-496b-b0ce-dbacf4b82757 | 4 |
| 751618 | nebivolol (as nebivolol hydrochloride) 2.5 MG Oral Tablet | SY | 375f239f-58a7-496b-b0ce-dbacf4b82757 | 4 |
| 827073 | nebivolol (as nebivolol hydrochloride) 20 MG Oral Tablet | SY | 375f239f-58a7-496b-b0ce-dbacf4b82757 | 4 |
| 387013 | nebivolol (as nebivolol hydrochloride) 5 MG Oral Tablet | SY | 375f239f-58a7-496b-b0ce-dbacf4b82757 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 27241-179-30 | 27241017930 | 30 TABLET in 1 BOTTLE (27241-179-30) | 30 tablet | 2022-03-31 | 0000-00-00 | No | No | Current |