Prescription drug · ANDA
Nebivolol NDC 71209-058
Nebivolol hydrochloride 2.5 mg/1 · Tablet · Oral · Cadila Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71209-058-01 | 71209005801 | 30 TABLET in 1 BOTTLE (71209-058-01)Marketed from Oct 16, 2018 | |
| 71209-058-04 | 71209005804 | 90 TABLET in 1 BOTTLE (71209-058-04)Marketed from Oct 16, 2018 | |
| 71209-058-05 | 71209005805 | 100 TABLET in 1 BOTTLE (71209-058-05)Marketed from Oct 16, 2018 | |
| 71209-058-11 | 71209005811 | 1000 TABLET in 1 BOTTLE (71209-058-11)Marketed from Oct 16, 2018 |
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 — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208717
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 71209-058_0ab335f1-2089-496b-b65f-02c697f6ee89SPL ID 0ab335f1-2089-496b-b65f-02c697f6ee89SPL set ID 451cdd6e-13b4-402f-8a44-cdf5f7433a49RxCUI 387013, 751612, 751618, 827073UNII JGS34J7L9IUPC 0371209060042, 0371209060059, 0371209058056
- 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
N471209005801followed by a unit qualifier and the quantityPackage 71209-0058-01. 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 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 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 of ant…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208717
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 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2415 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2414 |
| Nebivolol | Nebivolol hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2416 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2417 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-060 |
| Nebivolol | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-032 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-033 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-059 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-034 |
| Nebivolol | Nebivolol hydrochloride 20 mg/1 | TabletOral | Modavar Pharmaceuticals LLC | 72241-035 |
| Nebivolol | Nebivolol hydrochloride 20 mg/1 | TabletOral | Cadila Pharmaceuticals Limited | 71209-061 |