Prescription drug · ANDA
Nebivolol NDC 33342-458
Nebivolol hydrochloride 5 mg/1 · Tablet · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-458-07 | 33342045807 | 30 TABLET in 1 BOTTLE (33342-458-07)Marketed from Jan 29, 2025 | |
| 33342-458-10 | 33342045810 | 90 TABLET in 1 BOTTLE (33342-458-10)Marketed from Jan 29, 2025 | |
| 33342-458-25 | 33342045825 | 12 BLISTER PACK in 1 CARTON (33342-458-25) / 10 TABLET in 1 BLISTER PACKMarketed from Jan 29, 2025 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212661
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 33342-458_b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0eSPL ID b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0eSPL set ID b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0eRxCUI 387013, 751612, 751618, 827073UNII JGS34J7L9IUPC 0333342458070, 0333342459077, 0333342460073, 0333342457073
- 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
N433342045807followed by a unit qualifier and the quantityPackage 33342-0458-07. 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 controlle…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212661
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 5 mg/1 | TabletOral | NorthStar RxLLC | 72603-871 |
| Nebivolol | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | NorthStar RxLLC | 72603-870 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-459 |
| Nebivolol | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-457 |
| Nebivolol | Nebivolol hydrochloride 20 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-460 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | NorthStar RxLLC | 72603-872 |
| Nebivolol | Nebivolol hydrochloride 20 mg/1 | TabletOral | NorthStar RxLLC | 72603-873 |