Prescription drug · ANDA
Nebivolol NDC 67877-393
Nebivolol hydrochloride 2.5 mg/1 · Tablet · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-393-01 | 67877039301 | 100 TABLET in 1 BOTTLE (67877-393-01)Marketed from Sep 16, 2021 | |
| 67877-393-30 | 67877039330 | 30 TABLET in 1 BOTTLE (67877-393-30)Marketed from Sep 16, 2021 | |
| 67877-393-33 | 67877039333 | 1 BLISTER PACK in 1 CARTON (67877-393-33) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 16, 2021 | |
| 67877-393-90 | 67877039390 | 90 TABLET in 1 BOTTLE (67877-393-90)Marketed from Sep 16, 2021 |
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
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203828
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 67877-393_4f315a54-2598-4463-8884-0b643e86f8c0SPL ID 4f315a54-2598-4463-8884-0b643e86f8c0SPL set ID fecef8fc-b66b-4133-b66f-8d6b72750622RxCUI 387013, 751612, 751618, 827073UNII JGS34J7L9IUPC 0367877393308, 0367877391304, 0367877392905, 0367877390901
- 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
N467877039301followed by a unit qualifier and the quantityPackage 67877-0393-01. 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 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 trial…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203828
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 | A-S Medication Solutions | 50090-5708 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3527 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5752 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-5761 |
| Nebivolol | Nebivolol hydrochloride 20 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-390 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-391 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-392 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 60687-641 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | American Health Packaging | 60687-652 |