Prescription drug · ANDA
Nebivolol Hydrochloride NDC 29300-375
Nebivolol hydrochloride 2.5 mg/1 · Tablet · Oral · Unichem Pharmaceuticals (USA), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 29300-375-05 | 29300037505 | 500 TABLET in 1 BOTTLE (29300-375-05)Marketed from Apr 4, 2022 | |
| 29300-375-13 | 29300037513 | 30 TABLET in 1 BOTTLE (29300-375-13)Marketed from Apr 4, 2022 | |
| 29300-375-19 | 29300037519 | 90 TABLET in 1 BOTTLE (29300-375-19)Marketed from Apr 4, 2022 |
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 Hydrochloride
- Generic name (nonproprietary)
- nebivolol hydrochloride
- Active ingredients
- Nebivolol hydrochloride — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213830
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 29300-375_1a80b28a-62f6-443e-8e8d-fc89b74be5eaSPL ID 1a80b28a-62f6-443e-8e8d-fc89b74be5eaSPL set ID b1762bbb-b5be-48a7-8101-bb736f28845aRxCUI 387013, 751612, 751618, 827073UNII JGS34J7L9IUPC 0329300375138, 0329300376135, 0329300377132, 0329300378139
- 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
N429300037505followed by a unit qualifier and the quantityPackage 29300-0375-05. 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 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 seen in controlled trials …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213830
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 Hydrochloride | Nebivolol hydrochloride 10 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-377 |
| Nebivolol Hydrochloride | Nebivolol hydrochloride 5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-376 |
| Nebivolol Hydrochloride | Nebivolol hydrochloride 20 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-378 |