bisoprolol fumarate

Generic: bisoprolol fumarate

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

bisoprolol fumarate 5 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-603
Product ID 46708-603_ae10b8e1-557d-4437-8a1d-89d7844122c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204891
Listing Expiration 2026-12-31
Marketing Start 2019-09-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708603
Hyphenated Format 46708-603

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 ANDA204891 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-30)
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-31)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-71)
source: ndc

Packages (3)

46708-603-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-30) 46708-603-31 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-31) 46708-603-71 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-71)

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": "ae10b8e1-557d-4437-8a1d-89d7844122c8", "openfda": {"unii": ["UR59KN573L"], "rxcui": ["854901", "854905"], "spl_set_id": ["ae10b8e1-557d-4437-8a1d-89d7844122c8"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-30)", "package_ndc": "46708-603-30", "marketing_start_date": "20190911"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-31)", "package_ndc": "46708-603-31", "marketing_start_date": "20210325"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-71)", "package_ndc": "46708-603-71", "marketing_start_date": "20190911"}], "brand_name": "BISOPROLOL FUMARATE", "product_id": "46708-603_ae10b8e1-557d-4437-8a1d-89d7844122c8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "46708-603", "generic_name": "BISOPROLOL FUMARATE", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BISOPROLOL FUMARATE", "active_ingredients": [{"name": "BISOPROLOL FUMARATE", "strength": "5 mg/1"}], "application_number": "ANDA204891", "marketing_category": "ANDA", "marketing_start_date": "20190911", "listing_expiration_date": "20261231"}