bisoprolol fumarate

Generic: bisoprolol fumarate

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bisoprolol fumarate
Generic Name bisoprolol fumarate
Labeler solco healthcare us, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bisoprolol fumarate 5 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-616
Product ID 43547-616_e8b6cea1-8a7f-4255-8a24-ff96d6ceece2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217368
Listing Expiration 2026-12-31
Marketing Start 2022-07-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547616
Hyphenated Format 43547-616

Supplemental Identifiers

RxCUI
854901 854905
UPC
0343547616038 0343547617035
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 ANDA217368 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (43547-616-03)
  • 100 TABLET in 1 BOTTLE (43547-616-10)
  • 500 TABLET in 1 BOTTLE (43547-616-50)
source: ndc

Packages (3)

43547-616-03 30 TABLET in 1 BOTTLE (43547-616-03) 43547-616-10 100 TABLET in 1 BOTTLE (43547-616-10) 43547-616-50 500 TABLET in 1 BOTTLE (43547-616-50)

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": "e8b6cea1-8a7f-4255-8a24-ff96d6ceece2", "openfda": {"upc": ["0343547616038", "0343547617035"], "unii": ["UR59KN573L"], "rxcui": ["854901", "854905"], "spl_set_id": ["084308e4-3b8b-40d6-acbf-d775772a8a73"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43547-616-03)", "package_ndc": "43547-616-03", "marketing_start_date": "20220705"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (43547-616-10)", "package_ndc": "43547-616-10", "marketing_start_date": "20220705"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43547-616-50)", "package_ndc": "43547-616-50", "marketing_start_date": "20220705"}], "brand_name": "Bisoprolol fumarate", "product_id": "43547-616_e8b6cea1-8a7f-4255-8a24-ff96d6ceece2", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "43547-616", "generic_name": "Bisoprolol fumarate", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bisoprolol fumarate", "active_ingredients": [{"name": "BISOPROLOL FUMARATE", "strength": "5 mg/1"}], "application_number": "ANDA217368", "marketing_category": "ANDA", "marketing_start_date": "20220705", "listing_expiration_date": "20261231"}