bicalutamide

Generic: bicalutamide

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bicalutamide
Generic Name bicalutamide
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

bicalutamide 50 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-082
Product ID 82804-082_10e21544-f181-4cf8-9824-df0f49d19511
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079110
Listing Expiration 2026-12-31
Marketing Start 2014-12-15

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 82804082
Hyphenated Format 82804-082

Supplemental Identifiers

RxCUI
199123
UPC
0382804082902
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 ANDA079110 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (82804-082-90)
source: ndc

Packages (1)

82804-082-90 90 TABLET, FILM COATED in 1 BOTTLE (82804-082-90)

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": "10e21544-f181-4cf8-9824-df0f49d19511", "openfda": {"nui": ["N0000000243", "N0000175560"], "upc": ["0382804082902"], "unii": ["A0Z3NAU9DP"], "rxcui": ["199123"], "spl_set_id": ["10e21544-f181-4cf8-9824-df0f49d19511"], "pharm_class_epc": ["Androgen Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Androgen Receptor Antagonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (82804-082-90)", "package_ndc": "82804-082-90", "marketing_start_date": "20240313"}], "brand_name": "bicalutamide", "product_id": "82804-082_10e21544-f181-4cf8-9824-df0f49d19511", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]"], "product_ndc": "82804-082", "generic_name": "bicalutamide", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "bicalutamide", "active_ingredients": [{"name": "BICALUTAMIDE", "strength": "50 mg/1"}], "application_number": "ANDA079110", "marketing_category": "ANDA", "marketing_start_date": "20141215", "listing_expiration_date": "20261231"}