bisoprolol fumarate

Generic: bisoprolol fumarate

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

bisoprolol fumarate 5 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-127
Product ID 50268-127_0e85a1ff-1540-187e-e063-6394a90a3b1e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077910
Listing Expiration 2026-12-31
Marketing Start 2022-01-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268127
Hyphenated Format 50268-127

Supplemental Identifiers

RxCUI
854905
UNII
UR59KN573L

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 ANDA077910 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-127-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-127-11)
source: ndc

Packages (1)

50268-127-15 50 BLISTER PACK in 1 BOX (50268-127-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-127-11)

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": "0e85a1ff-1540-187e-e063-6394a90a3b1e", "openfda": {"unii": ["UR59KN573L"], "rxcui": ["854905"], "spl_set_id": ["d540ef44-9016-9d66-e053-2a95a90a16a9"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-127-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-127-11)", "package_ndc": "50268-127-15", "marketing_start_date": "20220110"}], "brand_name": "Bisoprolol Fumarate", "product_id": "50268-127_0e85a1ff-1540-187e-e063-6394a90a3b1e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "50268-127", "generic_name": "Bisoprolol Fumarate", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bisoprolol Fumarate", "active_ingredients": [{"name": "BISOPROLOL FUMARATE", "strength": "5 mg/1"}], "application_number": "ANDA077910", "marketing_category": "ANDA", "marketing_start_date": "20220110", "listing_expiration_date": "20261231"}