bicalutamide

Generic: bicalutamide

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

Drug Facts

Product Profile

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

bicalutamide 50 mg/1

Manufacturer
Golden State Medical Supply, Inc.

Identifiers & Regulatory

Product NDC 51407-010
Product ID 51407-010_45a1a56c-b3e9-0beb-e063-6294a90a83a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020498
Listing Expiration 2026-12-31
Marketing Start 1995-10-04

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 51407010
Hyphenated Format 51407-010

Supplemental Identifiers

RxCUI
199123
UPC
0351407010308
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 NDA020498 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (51407-010-30)
source: ndc

Packages (1)

51407-010-30 30 TABLET in 1 BOTTLE (51407-010-30)

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": "45a1a56c-b3e9-0beb-e063-6294a90a83a7", "openfda": {"nui": ["N0000000243", "N0000175560"], "upc": ["0351407010308"], "unii": ["A0Z3NAU9DP"], "rxcui": ["199123"], "spl_set_id": ["26e30155-a50b-df14-e063-6394a90a9be4"], "pharm_class_epc": ["Androgen Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Androgen Receptor Antagonists [MoA]"], "manufacturer_name": ["Golden State Medical Supply, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (51407-010-30)", "package_ndc": "51407-010-30", "marketing_start_date": "20240930"}], "brand_name": "Bicalutamide", "product_id": "51407-010_45a1a56c-b3e9-0beb-e063-6294a90a83a7", "dosage_form": "TABLET", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]"], "product_ndc": "51407-010", "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": "NDA020498", "marketing_category": "NDA", "marketing_start_date": "19951004", "listing_expiration_date": "20261231"}