bystolic

Generic: nebivolol hydrochloride

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bystolic
Generic Name nebivolol hydrochloride
Labeler allergan, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nebivolol hydrochloride 5 mg/1

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0456-1405
Product ID 0456-1405_0096cdf0-43e6-4128-8990-aed7e1fab83f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021742
Listing Expiration 2026-12-31
Marketing Start 2008-01-22

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04561405
Hyphenated Format 0456-1405

Supplemental Identifiers

RxCUI
387013 751612 751616 751618 751620 751623 827073 827075
UPC
0304561405909 0304561402304 0304561420902 0304561410903
UNII
JGS34J7L9I

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bystolic (source: ndc)
Generic Name nebivolol hydrochloride (source: ndc)
Application Number NDA021742 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0456-1405-01)
  • 30 TABLET in 1 BOTTLE (0456-1405-30)
  • 90 TABLET in 1 BOTTLE (0456-1405-90)
source: ndc

Packages (3)

0456-1405-01 100 TABLET in 1 BOTTLE (0456-1405-01) 0456-1405-30 30 TABLET in 1 BOTTLE (0456-1405-30) 0456-1405-90 90 TABLET in 1 BOTTLE (0456-1405-90)

Ingredients (1)

nebivolol hydrochloride (5 mg/1)

Linked Drug Pages (1)

Bystolic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0096cdf0-43e6-4128-8990-aed7e1fab83f", "openfda": {"upc": ["0304561405909", "0304561402304", "0304561420902", "0304561410903"], "unii": ["JGS34J7L9I"], "rxcui": ["387013", "751612", "751616", "751618", "751620", "751623", "827073", "827075"], "spl_set_id": ["8b8ad213-1dc8-454e-a524-075685c0e1a8"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0456-1405-01)", "package_ndc": "0456-1405-01", "marketing_start_date": "20080122"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (0456-1405-30)", "package_ndc": "0456-1405-30", "marketing_start_date": "20080122"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (0456-1405-90)", "package_ndc": "0456-1405-90", "marketing_start_date": "20080122"}], "brand_name": "Bystolic", "product_id": "0456-1405_0096cdf0-43e6-4128-8990-aed7e1fab83f", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "0456-1405", "generic_name": "nebivolol hydrochloride", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bystolic", "active_ingredients": [{"name": "NEBIVOLOL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "NDA021742", "marketing_category": "NDA", "marketing_start_date": "20080122", "listing_expiration_date": "20261231"}