Prescription drug · ANDA
Nebivolol NDC 62559-277
Nebivolol hydrochloride 10 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-277-05 | 62559027705 | 500 TABLET in 1 BOTTLE (62559-277-05)Marketed from Sep 17, 2021 | |
| 62559-277-30 | 62559027730 | 30 TABLET in 1 BOTTLE (62559-277-30)Marketed from Sep 17, 2021 | |
| 62559-277-90 | 62559027790 | 90 TABLET in 1 BOTTLE (62559-277-90)Marketed from Sep 17, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203659
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 62559-277_4bca2b49-cd1c-4645-99e7-511dd1b67da6SPL ID 4bca2b49-cd1c-4645-99e7-511dd1b67da6SPL set ID 3ebcc539-efe0-4545-bd83-37c20de7efb0RxCUI 387013, 751612, 751618, 827073UNII JGS34J7L9IUPC 0362559275309, 0362559276306, 0362559278300, 0362559277303
- 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
N462559027705followed by a unit qualifier and the quantityPackage 62559-0277-05. 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 control…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203659
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 | Golden State Medical Supply, Inc. | 51407-485 |
| Nebivolol | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-483 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-484 |
| Nebivolol | Nebivolol hydrochloride 20 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-486 |
| Nebivolol | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-275 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-276 |
| Nebivolol | Nebivolol hydrochloride 20 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-278 |