bicalutamide

Generic: bicalutamide

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bicalutamide
Generic Name bicalutamide
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bicalutamide 50 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8308
Product ID 63629-8308_01c32f48-8661-4d25-8e50-c6c97180cc42
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 636298308
Hyphenated Format 63629-8308

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 (63629-8308-1)
  • 100 TABLET in 1 BOTTLE (63629-8308-2)
source: ndc

Packages (2)

63629-8308-1 30 TABLET in 1 BOTTLE (63629-8308-1) 63629-8308-2 100 TABLET in 1 BOTTLE (63629-8308-2)

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": "01c32f48-8661-4d25-8e50-c6c97180cc42", "openfda": {"nui": ["N0000000243", "N0000175560"], "unii": ["A0Z3NAU9DP"], "rxcui": ["199123"], "spl_set_id": ["6d27f9b0-6b93-42fa-807e-fc819c0da14f"], "pharm_class_epc": ["Androgen Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Androgen Receptor Antagonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63629-8308-1)", "package_ndc": "63629-8308-1", "marketing_start_date": "20210608"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (63629-8308-2)", "package_ndc": "63629-8308-2", "marketing_start_date": "20200316"}], "brand_name": "Bicalutamide", "product_id": "63629-8308_01c32f48-8661-4d25-8e50-c6c97180cc42", "dosage_form": "TABLET", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]"], "product_ndc": "63629-8308", "generic_name": "Bicalutamide", "labeler_name": "Bryant Ranch Prepack", "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"}