bicalutamide

Generic: bicalutamide

Labeler: golden state medical supply, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bicalutamide
Generic Name bicalutamide
Labeler golden state medical supply, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

bicalutamide 50 mg/1

Manufacturer
Golden State Medical Supply, Inc.

Identifiers & Regulatory

Product NDC 60429-177
Product ID 60429-177_2cccc802-3402-4d27-e063-6394a90a0687
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078917
Marketing Start 2009-07-06
Marketing End 2026-08-31

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 60429177
Hyphenated Format 60429-177

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
  • 500 TABLET, FILM COATED in 1 BOTTLE (60429-177-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (60429-177-30)
source: ndc

Packages (2)

60429-177-05 500 TABLET, FILM COATED in 1 BOTTLE (60429-177-05) 60429-177-30 30 TABLET, FILM COATED in 1 BOTTLE (60429-177-30)

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": "2cccc802-3402-4d27-e063-6394a90a0687", "openfda": {"nui": ["N0000000243", "N0000175560"], "unii": ["A0Z3NAU9DP"], "rxcui": ["199123"], "spl_set_id": ["7c9a8877-7364-4a3c-9345-78279fa282eb"], "pharm_class_epc": ["Androgen Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Androgen Receptor Antagonists [MoA]"], "manufacturer_name": ["Golden State Medical Supply, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (60429-177-05)", "package_ndc": "60429-177-05", "marketing_end_date": "20260831", "marketing_start_date": "20140508"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (60429-177-30)", "package_ndc": "60429-177-30", "marketing_end_date": "20260831", "marketing_start_date": "20140508"}], "brand_name": "Bicalutamide", "product_id": "60429-177_2cccc802-3402-4d27-e063-6394a90a0687", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]"], "product_ndc": "60429-177", "generic_name": "Bicalutamide", "labeler_name": "Golden State Medical Supply, Inc.", "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": "20260831", "marketing_start_date": "20090706"}