bicalutamide

Generic: bicalutamide

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bicalutamide
Generic Name bicalutamide
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bicalutamide 50 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-890
Product ID 62559-890_cf149c3a-84aa-4ef8-befc-1dbeb7dcc678
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020498
Listing Expiration 2027-12-31
Marketing Start 2020-10-26

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 62559890
Hyphenated Format 62559-890

Supplemental Identifiers

RxCUI
199123
UPC
0362559890304
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 (62559-890-30)
source: ndc

Packages (1)

62559-890-30 30 TABLET in 1 BOTTLE (62559-890-30)

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": "cf149c3a-84aa-4ef8-befc-1dbeb7dcc678", "openfda": {"nui": ["N0000000243", "N0000175560"], "upc": ["0362559890304"], "unii": ["A0Z3NAU9DP"], "rxcui": ["199123"], "spl_set_id": ["7a08d88b-051a-4c16-9560-12685c500c58"], "pharm_class_epc": ["Androgen Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Androgen Receptor Antagonists [MoA]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (62559-890-30)", "package_ndc": "62559-890-30", "marketing_start_date": "20201026"}], "brand_name": "Bicalutamide", "product_id": "62559-890_cf149c3a-84aa-4ef8-befc-1dbeb7dcc678", "dosage_form": "TABLET", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]"], "product_ndc": "62559-890", "generic_name": "Bicalutamide", "labeler_name": "ANI Pharmaceuticals, 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": "20201026", "listing_expiration_date": "20271231"}