Prescription drug · ANDA
Nebivolol NDC 71335-2648
Nebivolol hydrochloride 5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2648-1 | 71335264801 | 30 TABLET in 1 BOTTLE (71335-2648-1)Marketed from Jun 3, 2025 | |
| 71335-2648-2 | 71335264802 | 90 TABLET in 1 BOTTLE (71335-2648-2)Marketed from Jun 3, 2025 |
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 hydrochloride — 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 217397
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 71335-2648_366e45a3-20d8-4707-ba64-d12985872b58SPL ID 366e45a3-20d8-4707-ba64-d12985872b58SPL set ID 156c41be-551b-46ab-86a8-52f6f70a4689RxCUI 387013UNII JGS34J7L9I
- 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
N471335264801followed by a unit qualifier and the quantityPackage 71335-2648-01. 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)
Nebivolol tablets are 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 seen in controlled …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217397
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 hydrochloride 10 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-152 |
| Nebivolol | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-150 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-151 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4648 |
| Nebivolol | Nebivolol hydrochloride 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-7853 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3102 |
| Nebivolol | Nebivolol hydrochloride 20 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-153 |