bicalutamide

Generic: bicalutamide

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bicalutamide
Generic Name bicalutamide
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

bicalutamide 50 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-485
Product ID 47335-485_3259c219-2548-4ea5-b6ad-e22f249879c7
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 47335485
Hyphenated Format 47335-485

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (47335-485-08)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (47335-485-18)
  • 30 TABLET, FILM COATED in 1 BOTTLE (47335-485-83)
  • 100 TABLET, FILM COATED in 1 BOTTLE (47335-485-88)
source: ndc

Packages (4)

47335-485-08 100 TABLET, FILM COATED in 1 BOTTLE (47335-485-08) 47335-485-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-485-18) 47335-485-83 30 TABLET, FILM COATED in 1 BOTTLE (47335-485-83) 47335-485-88 100 TABLET, FILM COATED in 1 BOTTLE (47335-485-88)

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": "3259c219-2548-4ea5-b6ad-e22f249879c7", "openfda": {"nui": ["N0000000243", "N0000175560"], "unii": ["A0Z3NAU9DP"], "rxcui": ["199123"], "spl_set_id": ["8b533fe4-287f-482c-b530-d9a5bf2ce40c"], "pharm_class_epc": ["Androgen Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Androgen Receptor Antagonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (47335-485-08)", "package_ndc": "47335-485-08", "marketing_start_date": "20141215"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (47335-485-18)", "package_ndc": "47335-485-18", "marketing_start_date": "20141215"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (47335-485-83)", "package_ndc": "47335-485-83", "marketing_start_date": "20141215"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (47335-485-88)", "package_ndc": "47335-485-88", "marketing_start_date": "20141215"}], "brand_name": "bicalutamide", "product_id": "47335-485_3259c219-2548-4ea5-b6ad-e22f249879c7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]"], "product_ndc": "47335-485", "generic_name": "bicalutamide", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "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"}