bisoprolol

Generic: bisoprolol fumarate

Labeler: trupharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

bisoprolol fumarate 5 mg/1

Manufacturer
TruPharma, LLC

Identifiers & Regulatory

Product NDC 52817-270
Product ID 52817-270_2a9e4180-cb1c-f924-e063-6394a90a60c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075474
Listing Expiration 2026-12-31
Marketing Start 2019-06-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52817270
Hyphenated Format 52817-270

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 (source: ndc)
Generic Name bisoprolol fumarate (source: ndc)
Application Number ANDA075474 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (52817-270-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (52817-270-30)
source: ndc

Packages (2)

52817-270-10 100 TABLET, FILM COATED in 1 BOTTLE (52817-270-10) 52817-270-30 30 TABLET, FILM COATED in 1 BOTTLE (52817-270-30)

Ingredients (1)

bisoprolol fumarate (5 mg/1)

Linked Drug Pages (1)

Bisoprolol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a9e4180-cb1c-f924-e063-6394a90a60c6", "openfda": {"unii": ["UR59KN573L"], "rxcui": ["854901", "854905"], "spl_set_id": ["bba0bc2b-602f-4df1-a761-85bd3c80c7de"], "manufacturer_name": ["TruPharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (52817-270-10)", "package_ndc": "52817-270-10", "marketing_start_date": "20190620"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (52817-270-30)", "package_ndc": "52817-270-30", "marketing_start_date": "20190620"}], "brand_name": "Bisoprolol", "product_id": "52817-270_2a9e4180-cb1c-f924-e063-6394a90a60c6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "52817-270", "generic_name": "Bisoprolol fumarate", "labeler_name": "TruPharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bisoprolol", "active_ingredients": [{"name": "BISOPROLOL FUMARATE", "strength": "5 mg/1"}], "application_number": "ANDA075474", "marketing_category": "ANDA", "marketing_start_date": "20190620", "listing_expiration_date": "20261231"}