bisoprolol fumarate

Generic: bisoprolol fumarate

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bisoprolol fumarate
Generic Name bisoprolol fumarate
Labeler viona pharmaceuticals inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

bisoprolol fumarate 5 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-111
Product ID 72578-111_d47ca4c0-7783-43d1-a951-5adca27ea13c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215680
Listing Expiration 2026-12-31
Marketing Start 2022-09-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578111
Hyphenated Format 72578-111

Supplemental Identifiers

RxCUI
854901 854905
UNII
UR59KN573L

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 bisoprolol fumarate (source: ndc)
Generic Name bisoprolol fumarate (source: ndc)
Application Number ANDA215680 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (72578-111-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (72578-111-06)
source: ndc

Packages (2)

72578-111-01 100 TABLET, FILM COATED in 1 BOTTLE (72578-111-01) 72578-111-06 30 TABLET, FILM COATED in 1 BOTTLE (72578-111-06)

Ingredients (1)

bisoprolol fumarate (5 mg/1)

Linked Drug Pages (1)

Bisoprolol Fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d47ca4c0-7783-43d1-a951-5adca27ea13c", "openfda": {"unii": ["UR59KN573L"], "rxcui": ["854901", "854905"], "spl_set_id": ["3c393b41-9423-4ea6-8a79-0cbff0693471"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72578-111-01)", "package_ndc": "72578-111-01", "marketing_start_date": "20220915"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72578-111-06)", "package_ndc": "72578-111-06", "marketing_start_date": "20220915"}], "brand_name": "Bisoprolol Fumarate", "product_id": "72578-111_d47ca4c0-7783-43d1-a951-5adca27ea13c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "72578-111", "generic_name": "Bisoprolol Fumarate", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bisoprolol Fumarate", "active_ingredients": [{"name": "BISOPROLOL FUMARATE", "strength": "5 mg/1"}], "application_number": "ANDA215680", "marketing_category": "ANDA", "marketing_start_date": "20220915", "listing_expiration_date": "20261231"}