NEBIVOLOL
- Product NDC
- 43547-525
- 11-digit product format
- 435470525
- Labeler code
- 43547
- Product ID
- 43547-525_a3b47cb5-4f9f-4788-945b-0012a54c0884
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nebivolol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA212682
- Marketing category
- ANDA
- Marketing start
- 2022-02-14
- Substance
- NEBIVOLOL
- 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 | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 030Y90569U |
| 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 |
|---|---|---|---|---|---|---|
| 43547-525-03 | NEBIVOLOL | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 43547-525-09 | NEBIVOLOL | 90 in 1 BOTTLE | TABLET | 90 | 3 | |
| 43547-525-50 | NEBIVOLOL | 500 in 1 BOTTLE | TABLET | 500 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-525-03 | EA - Each | 43547-525 | 1926abf0-3d3a-4173-aafd-88af9a62677e | 1 | 2022-07-06 |
| 43547-525-09 | EA - Each | 43547-525 | 00124635-0352-48e2-ae9b-06c814a10ef1 | 1 | 2022-07-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 387013 | nebivolol 5 MG Oral Tablet | PSN | 77fb6b5f-7bfe-4fc8-980c-fc688ac9837a | 103 |
| 387013 | nebivolol 5 MG Oral Tablet | SCD | 77fb6b5f-7bfe-4fc8-980c-fc688ac9837a | 103 |
| 387013 | nebivolol (as nebivolol hydrochloride) 5 MG Oral Tablet | SY | 77fb6b5f-7bfe-4fc8-980c-fc688ac9837a | 103 |
| 751612 | nebivolol 10 MG Oral Tablet | PSN | 3e9e1048-b5ea-4d6a-9363-3ee0d059e088 | 4 |
| 751618 | nebivolol 2.5 MG Oral Tablet | PSN | 3e9e1048-b5ea-4d6a-9363-3ee0d059e088 | 4 |
| 827073 | nebivolol 20 MG Oral Tablet | PSN | 3e9e1048-b5ea-4d6a-9363-3ee0d059e088 | 4 |
| 387013 | nebivolol 5 MG Oral Tablet | PSN | 3e9e1048-b5ea-4d6a-9363-3ee0d059e088 | 4 |
| 751612 | nebivolol 10 MG Oral Tablet | SCD | 3e9e1048-b5ea-4d6a-9363-3ee0d059e088 | 4 |
| 751618 | nebivolol 2.5 MG Oral Tablet | SCD | 3e9e1048-b5ea-4d6a-9363-3ee0d059e088 | 4 |
| 827073 | nebivolol 20 MG Oral Tablet | SCD | 3e9e1048-b5ea-4d6a-9363-3ee0d059e088 | 4 |
| 387013 | nebivolol 5 MG Oral Tablet | SCD | 3e9e1048-b5ea-4d6a-9363-3ee0d059e088 | 4 |
| 751612 | nebivolol (as nebivolol hydrochloride) 10 MG Oral Tablet | SY | 3e9e1048-b5ea-4d6a-9363-3ee0d059e088 | 4 |
| 751618 | nebivolol (as nebivolol hydrochloride) 2.5 MG Oral Tablet | SY | 3e9e1048-b5ea-4d6a-9363-3ee0d059e088 | 4 |
| 827073 | nebivolol (as nebivolol hydrochloride) 20 MG Oral Tablet | SY | 3e9e1048-b5ea-4d6a-9363-3ee0d059e088 | 4 |
| 387013 | nebivolol (as nebivolol hydrochloride) 5 MG Oral Tablet | SY | 3e9e1048-b5ea-4d6a-9363-3ee0d059e088 | 4 |
| 387013 | nebivolol 5 MG Oral Tablet | PSN | a9bad35e-cd48-48f1-93ca-46490dbf70a8 | 2 |
| 387013 | nebivolol 5 MG Oral Tablet | PSN | 126de78c-fb3d-4a53-9aaf-f2dfe1ac2a2f | 2 |
| 387013 | nebivolol 5 MG Oral Tablet | SCD | 126de78c-fb3d-4a53-9aaf-f2dfe1ac2a2f | 2 |
| 387013 | nebivolol 5 MG Oral Tablet | SCD | a9bad35e-cd48-48f1-93ca-46490dbf70a8 | 2 |
| 387013 | nebivolol (as nebivolol hydrochloride) 5 MG Oral Tablet | SY | a9bad35e-cd48-48f1-93ca-46490dbf70a8 | 2 |
| 387013 | nebivolol (as nebivolol hydrochloride) 5 MG Oral Tablet | SY | 126de78c-fb3d-4a53-9aaf-f2dfe1ac2a2f | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43547-525-03 | 43547052503 | 30 TABLET in 1 BOTTLE (43547-525-03) | 30 tablet | 2022-02-14 | 0000-00-00 | No | No | Current |
| 43547-525-09 | 43547052509 | 90 TABLET in 1 BOTTLE (43547-525-09) | 90 tablet | 2022-02-14 | 0000-00-00 | No | No | Current |
| 43547-525-50 | 43547052550 | 500 TABLET in 1 BOTTLE (43547-525-50) | 500 tablet | 2022-02-14 | 0000-00-00 | No | No | Current |