bisoprolol fumarate

Generic: bisoprolol fumarate

Labeler: novitium pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bisoprolol fumarate
Generic Name bisoprolol fumarate
Labeler novitium pharma llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bisoprolol fumarate 5 mg/1

Manufacturer
Novitium Pharma LLC

Identifiers & Regulatory

Product NDC 70954-455
Product ID 70954-455_6517d564-ea55-4084-a8ab-34fea548c24e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215563
Listing Expiration 2026-12-31
Marketing Start 2021-10-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954455
Hyphenated Format 70954-455

Supplemental Identifiers

RxCUI
854901 854905
UPC
0370954456100 0370954456209 0370954455103 0370954455202
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 ANDA215563 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (70954-455-10)
  • 100 TABLET in 1 BOTTLE (70954-455-20)
source: ndc

Packages (2)

70954-455-10 30 TABLET in 1 BOTTLE (70954-455-10) 70954-455-20 100 TABLET in 1 BOTTLE (70954-455-20)

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": "6517d564-ea55-4084-a8ab-34fea548c24e", "openfda": {"upc": ["0370954456100", "0370954456209", "0370954455103", "0370954455202"], "unii": ["UR59KN573L"], "rxcui": ["854901", "854905"], "spl_set_id": ["6517d564-ea55-4084-a8ab-34fea548c24e"], "manufacturer_name": ["Novitium Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (70954-455-10)", "package_ndc": "70954-455-10", "marketing_start_date": "20211029"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-455-20)", "package_ndc": "70954-455-20", "marketing_start_date": "20211029"}], "brand_name": "Bisoprolol Fumarate", "product_id": "70954-455_6517d564-ea55-4084-a8ab-34fea548c24e", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "70954-455", "generic_name": "Bisoprolol Fumarate", "labeler_name": "Novitium Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bisoprolol Fumarate", "active_ingredients": [{"name": "BISOPROLOL FUMARATE", "strength": "5 mg/1"}], "application_number": "ANDA215563", "marketing_category": "ANDA", "marketing_start_date": "20211029", "listing_expiration_date": "20261231"}