Prescription drug · ANDA
Nebivolol NDC 59651-137
Nebivolol hydrochloride 2.5 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-137-30 | 5965101373059651013730 | 30 TABLET in 1 BOTTLE (59651-137-30)Marketed from Feb 19, 2025 | |
| 59651-137-90 | 5965101379059651013790 | 90 TABLET in 1 BOTTLE (59651-137-90)Marketed from Feb 19, 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 — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211053
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 59651-137_2690da17-6194-47ba-9078-e27821283ee2SPL ID 2690da17-6194-47ba-9078-e27821283ee2SPL set ID 6e43a4e2-574e-4f4a-804d-e346b4edd2f1RxCUI 387013, 751612, 751618, 827073UNII JGS34J7L9IUPC 0359651137307
- 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
N459651013730followed by a unit qualifier and the quantityPackage 59651-0137-30. 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.
About NDC 59651-137
- What is NDC 59651-137?
- 59651-137 is the product NDC for Nebivolol, Nebivolol hydrochloride 2.5 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nebivolol.
- What is the active ingredient?
- Nebivolol hydrochloride.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nebivolol?
- 89 other product NDCs are listed under this name. See all Nebivolol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nebivolol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nebivolol | Nebivolol 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7500 | 00904-7500-04 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4648 | 70518-4648-00 |
| Nebivolol | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | NorthStar RxLLC | 72603-870 | 72603-0870-01 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | NorthStar RxLLC | 72603-871 | 72603-0871-0172603-0871-02 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | NorthStar RxLLC | 72603-872 | 72603-0872-0172603-0872-02 |
| Nebivolol | Nebivolol hydrochloride 20 mg/1 | TabletOral | NorthStar RxLLC | 72603-873 | 72603-0873-0172603-0873-02 |
| Nebivolol | Nebivolol 2.5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7497 | 00904-7497-04 |
| Nebivolol | Nebivolol 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7498 | 00904-7498-04 |
| Nebivolol | Nebivolol 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7499 | 00904-7499-04 |
| Nebivolol | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-457 | 33342-0457-0733342-0457-1033342-0457-25 |
Other NDCs under ANDA 211053
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 20 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-140 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-138 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-139 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9424 |
| Nebivolol | Nebivolol hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9423 |