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
Routes
ORAL
Active Ingredients

bicalutamide 50 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-577
Product ID 71205-577_d8a5e670-a721-42c1-a384-4efe056f3a65
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078917
Listing Expiration 2026-12-31
Marketing Start 2009-07-06

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 71205577
Hyphenated Format 71205-577

Supplemental Identifiers

RxCUI
199123
UPC
0371205577308
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 (71205-577-30)
  • 60 TABLET in 1 BOTTLE (71205-577-60)
  • 90 TABLET in 1 BOTTLE (71205-577-90)
source: ndc

Packages (3)

71205-577-30 30 TABLET in 1 BOTTLE (71205-577-30) 71205-577-60 60 TABLET in 1 BOTTLE (71205-577-60) 71205-577-90 90 TABLET in 1 BOTTLE (71205-577-90)

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": "d8a5e670-a721-42c1-a384-4efe056f3a65", "openfda": {"nui": ["N0000000243", "N0000175560"], "upc": ["0371205577308"], "unii": ["A0Z3NAU9DP"], "rxcui": ["199123"], "spl_set_id": ["c5c04006-0078-4fd7-9ecd-c50d8d9fa5d6"], "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": "30 TABLET in 1 BOTTLE (71205-577-30)", "package_ndc": "71205-577-30", "marketing_start_date": "20210609"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71205-577-60)", "package_ndc": "71205-577-60", "marketing_start_date": "20210609"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71205-577-90)", "package_ndc": "71205-577-90", "marketing_start_date": "20210609"}], "brand_name": "Bicalutamide", "product_id": "71205-577_d8a5e670-a721-42c1-a384-4efe056f3a65", "dosage_form": "TABLET", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]"], "product_ndc": "71205-577", "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": "ANDA078917", "marketing_category": "ANDA", "marketing_start_date": "20090706", "listing_expiration_date": "20261231"}