bisoprolol fumarate

Generic: bisoprolol fumarate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bisoprolol fumarate
Generic Name bisoprolol fumarate
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

bisoprolol fumarate 5 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-392
Product ID 72789-392_31f66fad-b441-4f0e-e063-6394a90a3518
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217617
Listing Expiration 2026-12-31
Marketing Start 2024-03-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789392
Hyphenated Format 72789-392

Supplemental Identifiers

RxCUI
854905
UPC
0372789392820
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 ANDA217617 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-392-82)
source: ndc

Packages (1)

72789-392-82 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-392-82)

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": "31f66fad-b441-4f0e-e063-6394a90a3518", "openfda": {"upc": ["0372789392820"], "unii": ["UR59KN573L"], "rxcui": ["854905"], "spl_set_id": ["c8fa858c-7e42-4134-9fc6-604a11a66fe2"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-392-82)", "package_ndc": "72789-392-82", "marketing_start_date": "20240417"}], "brand_name": "BISOPROLOL FUMARATE", "product_id": "72789-392_31f66fad-b441-4f0e-e063-6394a90a3518", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "72789-392", "generic_name": "BISOPROLOL FUMARATE", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BISOPROLOL FUMARATE", "active_ingredients": [{"name": "BISOPROLOL FUMARATE", "strength": "5 mg/1"}], "application_number": "ANDA217617", "marketing_category": "ANDA", "marketing_start_date": "20240310", "listing_expiration_date": "20261231"}