Prescription drug · ANDA
Nebivolol NDC 71335-2516
Nebivolol 5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2516-1 | 71335251601 | 30 TABLET in 1 BOTTLE (71335-2516-1)Marketed from Oct 24, 2024 | |
| 71335-2516-2 | 71335251602 | 90 TABLET in 1 BOTTLE (71335-2516-2)Marketed from Oct 24, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Nebivolol
- Generic name (nonproprietary)
- nebivolol
- Active ingredients
- Nebivolol — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212682
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 71335-2516_afe4a662-64fe-49a5-a45c-2bee2070ef85SPL ID afe4a662-64fe-49a5-a45c-2bee2070ef85SPL set ID 126de78c-fb3d-4a53-9aaf-f2dfe1ac2a2fRxCUI 387013UNII 030Y90569U
- Pharmacologic class
- beta-Adrenergic Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471335251601followed by a unit qualifier and the quantityPackage 71335-2516-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
1. INDICATIONS AND USAGE Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) 1.1 Hypertension Nebivolol tablets are indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies ( 14.1 )]. Nebivolol tablets may be used alone or in combination with other antihypertensive agents [see Drug Interactions ( 7 )]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been s…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212682
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nebivolol | Nebivolol 20 mg/1 | TabletOral | Direct_Rx | 72189-592 |
| Nebivolol | Nebivolol 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-7301 |
| Nebivolol | Nebivolol 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9589 |
| Nebivolol | Nebivolol 2.5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-524 |
| Nebivolol | Nebivolol 5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-525 |
| Nebivolol | Nebivolol 10 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-526 |
| Nebivolol | Nebivolol 20 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-527 |
| Nebivolol | Nebivolol 2.5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7497 |
| Nebivolol | Nebivolol 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7498 |
| Nebivolol | Nebivolol 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7499 |
| Nebivolol | Nebivolol 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7500 |
| Nebivololnebibolol | Nebivolol 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2443 |
| Nebivololnebibolol | Nebivolol 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7185 |
| Nebivolol | Nebivolol 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4032 |