bisoprolol fumarate

Generic: bisoprolol fumarate

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

Drug Facts

Product Profile

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

bisoprolol fumarate 10 mg/1

Manufacturer
Natco Pharma USA LLC

Identifiers & Regulatory

Product NDC 69339-237
Product ID 69339-237_e907bfcb-5e64-45b8-ae9d-822b3d360104
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075831
Listing Expiration 2026-12-31
Marketing Start 2024-11-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69339237
Hyphenated Format 69339-237

Supplemental Identifiers

RxCUI
854901 854905
UPC
0369339237038 0369339236031 0369339236017
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 ANDA075831 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (69339-237-01)
  • 30 TABLET in 1 BOTTLE, PLASTIC (69339-237-03)
source: ndc

Packages (2)

69339-237-01 100 TABLET in 1 BOTTLE, PLASTIC (69339-237-01) 69339-237-03 30 TABLET in 1 BOTTLE, PLASTIC (69339-237-03)

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": "e907bfcb-5e64-45b8-ae9d-822b3d360104", "openfda": {"upc": ["0369339237038", "0369339236031", "0369339236017"], "unii": ["UR59KN573L"], "rxcui": ["854901", "854905"], "spl_set_id": ["e907bfcb-5e64-45b8-ae9d-822b3d360104"], "manufacturer_name": ["Natco Pharma USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (69339-237-01)", "package_ndc": "69339-237-01", "marketing_start_date": "20241125"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (69339-237-03)", "package_ndc": "69339-237-03", "marketing_start_date": "20241125"}], "brand_name": "Bisoprolol fumarate", "product_id": "69339-237_e907bfcb-5e64-45b8-ae9d-822b3d360104", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "69339-237", "generic_name": "Bisoprolol fumarate", "labeler_name": "Natco Pharma USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bisoprolol fumarate", "active_ingredients": [{"name": "BISOPROLOL FUMARATE", "strength": "10 mg/1"}], "application_number": "ANDA075831", "marketing_category": "ANDA", "marketing_start_date": "20241125", "listing_expiration_date": "20261231"}