bisoprolol fumarate

Generic: bisoprolol fumarate

Labeler: harman finochem limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bisoprolol fumarate
Generic Name bisoprolol fumarate
Labeler harman finochem limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bisoprolol fumarate 10 mg/1

Manufacturer
Harman Finochem Limited

Identifiers & Regulatory

Product NDC 82638-108
Product ID 82638-108_189028b6-aef4-6dd5-e063-6394a90afeed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217617
Listing Expiration 2026-12-31
Marketing Start 2024-05-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82638108
Hyphenated Format 82638-108

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 ANDA217617 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (82638-108-01)
  • 100 TABLET in 1 BOTTLE (82638-108-02)
source: ndc

Packages (2)

82638-108-01 30 TABLET in 1 BOTTLE (82638-108-01) 82638-108-02 100 TABLET in 1 BOTTLE (82638-108-02)

Ingredients (1)

bisoprolol fumarate (10 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": "189028b6-aef4-6dd5-e063-6394a90afeed", "openfda": {"unii": ["UR59KN573L"], "rxcui": ["854901", "854905"], "spl_set_id": ["65da2d2e-cce8-4bf6-a12d-3565b4b6b7c8"], "manufacturer_name": ["Harman Finochem Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (82638-108-01)", "package_ndc": "82638-108-01", "marketing_start_date": "20240730"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (82638-108-02)", "package_ndc": "82638-108-02", "marketing_start_date": "20240730"}], "brand_name": "Bisoprolol Fumarate", "product_id": "82638-108_189028b6-aef4-6dd5-e063-6394a90afeed", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "82638-108", "generic_name": "Bisoprolol Fumarate", "labeler_name": "Harman Finochem Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bisoprolol Fumarate", "active_ingredients": [{"name": "BISOPROLOL FUMARATE", "strength": "10 mg/1"}], "application_number": "ANDA217617", "marketing_category": "ANDA", "marketing_start_date": "20240512", "listing_expiration_date": "20261231"}