bicalutamide

Generic: bicalutamide

Labeler: viona pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bicalutamide
Generic Name bicalutamide
Labeler viona pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bicalutamide 50 mg/1

Manufacturer
Viona Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72578-215
Product ID 72578-215_7f9961d0-109d-4640-bedc-319663483652
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079089
Listing Expiration 2026-12-31
Marketing Start 2009-06-07

Pharmacologic Class

Established (EPC)
androgen receptor inhibitor [epc]
Mechanism of Action
androgen receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578215
Hyphenated Format 72578-215

Supplemental Identifiers

RxCUI
199123
UPC
0372578215064 0372578215019
UNII
A0Z3NAU9DP
NUI
N0000000243 N0000175560

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 bicalutamide (source: ndc)
Generic Name bicalutamide (source: ndc)
Application Number ANDA079089 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72578-215-01)
  • 30 TABLET in 1 BOTTLE (72578-215-06)
source: ndc

Packages (2)

72578-215-01 100 TABLET in 1 BOTTLE (72578-215-01) 72578-215-06 30 TABLET in 1 BOTTLE (72578-215-06)

Ingredients (1)

bicalutamide (50 mg/1)

Linked Drug Pages (1)

Bicalutamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7f9961d0-109d-4640-bedc-319663483652", "openfda": {"nui": ["N0000000243", "N0000175560"], "upc": ["0372578215064", "0372578215019"], "unii": ["A0Z3NAU9DP"], "rxcui": ["199123"], "spl_set_id": ["5a7cbe80-f119-4b3d-949a-c7824ea91908"], "pharm_class_epc": ["Androgen Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Androgen Receptor Antagonists [MoA]"], "manufacturer_name": ["Viona Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72578-215-01)", "package_ndc": "72578-215-01", "marketing_start_date": "20090607"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72578-215-06)", "package_ndc": "72578-215-06", "marketing_start_date": "20090607"}], "brand_name": "Bicalutamide", "product_id": "72578-215_7f9961d0-109d-4640-bedc-319663483652", "dosage_form": "TABLET", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]"], "product_ndc": "72578-215", "generic_name": "Bicalutamide", "labeler_name": "Viona Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bicalutamide", "active_ingredients": [{"name": "BICALUTAMIDE", "strength": "50 mg/1"}], "application_number": "ANDA079089", "marketing_category": "ANDA", "marketing_start_date": "20090607", "listing_expiration_date": "20261231"}