Prescription drug · ANDA
Nebivolol (Nebibolol) NDC 71335-2443
Nebivolol 10 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2443-1 | 7133524430171335244301 | 30 TABLET in 1 BOTTLE (71335-2443-1)Marketed from Aug 15, 2024 | |
| 71335-2443-2 | 7133524430271335244302 | 90 TABLET in 1 BOTTLE (71335-2443-2)Marketed from Aug 15, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- nebibolol
- Active ingredients
- Nebivolol — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212682
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 71335-2443_3e583d86-66cb-4a0f-a868-416721f24ad1SPL ID 3e583d86-66cb-4a0f-a868-416721f24ad1SPL set ID 78c0945a-b8dc-4397-95d5-9f209224ad5eRxCUI 751612UNII 030Y90569U
- 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
N471335244301followed by a unit qualifier and the quantityPackage 71335-2443-01. 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)
1. INDICATIONS AND USAGE 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 s…
Excerpt only. Read the full label for complete information.
About NDC 71335-2443
- What is NDC 71335-2443?
- 71335-2443 is the product NDC for Nebivolol (nebibolol), Nebivolol 10 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nebivolol (Nebibolol).
- What is the active ingredient?
- Nebivolol.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 212682
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 2.5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7497 |
| Nebivolol | Nebivolol 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7498 |
| Nebivolol | Nebivolol 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7499 |
| Nebivolol | Nebivolol 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7500 |
| Nebivolol | Nebivolol 2.5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-524 |
| Nebivolol | Nebivolol 5 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-525 |
| Nebivolol | Nebivolol 10 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-526 |
| Nebivolol | Nebivolol 20 mg/1 | TabletOral | Solco Healthcare US, LLC | 43547-527 |
| Nebivololnebibolol | Nebivolol 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7185 |
| Nebivolol | Nebivolol 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-7301 |
| Nebivolol | Nebivolol 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9589 |
| Nebivolol | Nebivolol 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4032 |
| Nebivolol | Nebivolol 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2516 |
| Nebivolol | Nebivolol 20 mg/1 | TabletOral | Direct_Rx | 72189-592 |