bicalutamide

Generic: bicalutamide

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bicalutamide
Generic Name bicalutamide
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bicalutamide 50 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6019
Product ID 0904-6019_8ac6fd8c-6c02-4bd1-8e19-ab1a6ce4b9c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078917
Marketing Start 2010-05-11
Marketing End 2026-03-31

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 09046019
Hyphenated Format 0904-6019

Supplemental Identifiers

RxCUI
199123
UNII
A0Z3NAU9DP
NUI
N0000000243 N0000175560

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 ANDA078917 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0904-6019-46)
source: ndc

Packages (1)

0904-6019-46 30 TABLET in 1 BOTTLE (0904-6019-46)

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": "8ac6fd8c-6c02-4bd1-8e19-ab1a6ce4b9c1", "openfda": {"nui": ["N0000000243", "N0000175560"], "unii": ["A0Z3NAU9DP"], "rxcui": ["199123"], "spl_set_id": ["82d4877e-6ebf-4f75-a108-28dc840b07fc"], "pharm_class_epc": ["Androgen Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Androgen Receptor Antagonists [MoA]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0904-6019-46)", "package_ndc": "0904-6019-46", "marketing_end_date": "20260331", "marketing_start_date": "20100511"}], "brand_name": "Bicalutamide", "product_id": "0904-6019_8ac6fd8c-6c02-4bd1-8e19-ab1a6ce4b9c1", "dosage_form": "TABLET", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]"], "product_ndc": "0904-6019", "generic_name": "Bicalutamide", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bicalutamide", "active_ingredients": [{"name": "BICALUTAMIDE", "strength": "50 mg/1"}], "application_number": "ANDA078917", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20100511"}