Prescription drug · ANDA
Nebivolol NDC 70518-4032
Nebivolol 5 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4032-0 | 70518403200 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4032-0)Marketed from Mar 5, 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
- REMEDYREPACK INC.
- 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 70518-4032_3f91fb6d-6d25-a881-e063-6394a90a3c61SPL ID 3f91fb6d-6d25-a881-e063-6394a90a3c61SPL set ID a9bad35e-cd48-48f1-93ca-46490dbf70a8RxCUI 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
N470518403200followed by a unit qualifier and the quantityPackage 70518-4032-00. 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 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 ha…
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 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2516 |
| 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 |