Prescription drug · NDA
Bystolic (Nebivolol hydrochloride) NDC 0456-1405
Nebivolol hydrochloride 5 mg/1 · Tablet · Oral · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0456-1405-01 | 0045614050100456140501 | 100 TABLET in 1 BOTTLE (0456-1405-01)Marketed from Jan 22, 2008 | |
| 0456-1405-30 | 0045614053000456140530 | 30 TABLET in 1 BOTTLE (0456-1405-30)Marketed from Jan 22, 2008 | |
| 0456-1405-90 | 0045614059000456140590 | 90 TABLET in 1 BOTTLE (0456-1405-90)Marketed from Jan 22, 2008 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Bystolic
- Generic name (nonproprietary)
- nebivolol hydrochloride
- Active ingredients
- Nebivolol hydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Allergan, Inc.NDC labeler code 0456
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021742
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 0456-1405_0096cdf0-43e6-4128-8990-aed7e1fab83fSPL ID 0096cdf0-43e6-4128-8990-aed7e1fab83fSPL set ID 8b8ad213-1dc8-454e-a524-075685c0e1a8RxCUI 387013, 751612, 751616, 751618, 751620, 751623, 827073, 827075UNII JGS34J7L9IUPC 0304561405909, 0304561402304, 0304561420902, 0304561410903
- 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
N400456140501followed by a unit qualifier and the quantityPackage 00456-1405-01. 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 BYSTOLIC 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 BYSTOLIC is indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies ( 14.1 )]. BYSTOLIC 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 tr…
Excerpt only. Read the full label for complete information.
About NDC 0456-1405
- What is NDC 0456-1405?
- 0456-1405 is the product NDC for Bystolic (nebivolol hydrochloride), Nebivolol hydrochloride 5 mg/1 tablet, listed with the FDA by Allergan, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bystolic (Nebivolol hydrochloride).
- What is the active ingredient?
- Nebivolol hydrochloride.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 0456. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bystolic?
- 3 other product NDCs are listed under this name. See all Bystolic NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bystolic products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bystolicnebivolol hydrochloride | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | Allergan, Inc. | 0456-1402 | 00456-1402-0100456-1402-3000456-1402-90 |
| Bystolicnebivolol hydrochloride | Nebivolol hydrochloride 10 mg/1 | TabletOral | Allergan, Inc. | 0456-1410 | 00456-1410-0100456-1410-3000456-1410-63+1 more |
| Bystolicnebivolol hydrochloride | Nebivolol hydrochloride 20 mg/1 | TabletOral | Allergan, Inc. | 0456-1420 | 00456-1420-0100456-1420-6300456-1420-90 |
Other NDCs under NDA 021742
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 |
|---|---|---|---|---|
| Bystolicnebivolol hydrochloride | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | Allergan, Inc. | 0456-1402 |
| Bystolicnebivolol hydrochloride | Nebivolol hydrochloride 10 mg/1 | TabletOral | Allergan, Inc. | 0456-1410 |
| Bystolicnebivolol hydrochloride | Nebivolol hydrochloride 20 mg/1 | TabletOral | Allergan, Inc. | 0456-1420 |