FDA.reportPublic FDA data

BICALUTAMIDE

Substance profile for UNII A0Z3NAU9DP, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for BICALUTAMIDE
Structure render from PubChem CID 2375

Substance Identity#

UNII
A0Z3NAU9DP
Preferred term
BICALUTAMIDE
Registry number
90357-06-5
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C18H14F4N2O4S
Chemical structure for BICALUTAMIDE
Structure render from PubChem CID 2375

Chemical And Database Identifiers#

SMILES
CC(O)(CS(=O)(=O)C1=CC=C(F)C=C1)C(=O)NC2=CC(=C(C=C2)C#N)C(F)(F)F
RxCUI
83008
PubChem
2375
NCIt
C1599
INN ID
7021

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound2375pubchem.ncbi.nlm.nih.gov/compound/2375
RxNorm83008mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=83008
NCI ThesaurusC1599ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C1599
FDA Substance Registration SystemA0Z3NAU9DPprecision.fda.gov/uniisearch/srs/unii/A0Z3NAU9DP

DailyMed Socrata Ingredients#

Type, DailyMed label, SPL version table
TypeDailyMed labelSPL version
ACTIVE MOIETYThese highlights do not include all the information needed to use bicalutamide safely and effectively. See full prescribing information for bicalutamide. Bicalutamide Tablets USP for Oral use Initial U.S. Approval : 19951
ACTIVE INGREDIENTThese highlights do not include all the information needed to use bicalutamide safely and effectively. See full prescribing information for bicalutamide. Bicalutamide Tablets USP for Oral use Initial U.S. Approval : 19951
ACTIVE MOIETYThese highlights do not include all the information needed to use CASODEX® safely and effectively. See full prescribing information for CASODEX. CASODEX® (bicalutamide) Tablet for Oral use Initial U.S. Approval: 19952
ACTIVE INGREDIENTThese highlights do not include all the information needed to use CASODEX® safely and effectively. See full prescribing information for CASODEX. CASODEX® (bicalutamide) Tablet for Oral use Initial U.S. Approval: 19952
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Bicalutamide Tablets, USP safely and effectively. See full prescribing information for Bicalutamide Tablets, USP. Bicalutamide Tablets, USP for Oral use Initial U.S. Approval: 19951
ACTIVE MOIETYThese highlights do not include all the information needed to use Bicalutamide Tablets, USP safely and effectively. See full prescribing information for Bicalutamide Tablets, USP. Bicalutamide Tablets, USP for Oral use Initial U.S. Approval: 19951
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Bicalutamide Tablets, USP safely and effectively. See full prescribing information for Bicalutamide Tablets, USP. Bicalutamide Tablets, USP for Oral use Initial U.S. Approval: 19951
ACTIVE MOIETYThese highlights do not include all the information needed to use Bicalutamide Tablets, USP safely and effectively. See full prescribing information for Bicalutamide Tablets, USP. Bicalutamide Tablets, USP for Oral use Initial U.S. Approval: 19951
ACTIVE INGREDIENTThese highlights do not include all the information needed to use bicalutamide tablets USP safely and effectively. See full prescribing information for bicalutamide tablets USP. Bicalutamide Tablets USP for Oral use Initial U.S. Approval: 19951
ACTIVE MOIETYThese highlights do not include all the information needed to use bicalutamide tablets USP safely and effectively. See full prescribing information for bicalutamide tablets USP. Bicalutamide Tablets USP for Oral use Initial U.S. Approval: 19951
ACTIVE MOIETYBICALUTAMIDE TABLET [BRYANT RANCH PREPACK]1000
ACTIVE INGREDIENTBICALUTAMIDE TABLET [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYBICALUTAMIDE TABLET [SANDOZ INC]16
ACTIVE INGREDIENTBICALUTAMIDE TABLET [SANDOZ INC]16
ACTIVE MOIETYCASODEX (BICALUTAMIDE) TABLET [ASTRAZENECA PHARMACEUTICALS LP]13
ACTIVE INGREDIENTCASODEX (BICALUTAMIDE) TABLET [ASTRAZENECA PHARMACEUTICALS LP]13
ACTIVE INGREDIENTBICALUTAMIDE TABLET [SUN PHARMA GLOBAL INC.]6
ACTIVE MOIETYBICALUTAMIDE TABLET [SUN PHARMA GLOBAL INC.]6
ACTIVE INGREDIENTBICALUTAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC]5
ACTIVE MOIETYBICALUTAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC]5
ACTIVE INGREDIENTBICALUTAMIDE TABLET, FILM COATED [NORTHSTAR RXLLC]5
ACTIVE MOIETYBICALUTAMIDE TABLET, FILM COATED [NORTHSTAR RXLLC]5
ACTIVE MOIETYBICALUTAMIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
ACTIVE INGREDIENTBICALUTAMIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
ACTIVE INGREDIENTBICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]5
ACTIVE MOIETYBICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]5
ACTIVE INGREDIENTBICALUTAMIDE TABLET [ACCORD HEALTHCARE INC.]2
ACTIVE MOIETYBICALUTAMIDE TABLET [ACCORD HEALTHCARE INC.]2
ACTIVE INGREDIENTBICALUTAMIDE TABLET [AMERICAN HEALTH PACKAGING]2
ACTIVE MOIETYBICALUTAMIDE TABLET [AMERICAN HEALTH PACKAGING]2
ACTIVE MOIETYBICALUTAMIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
ACTIVE INGREDIENTBICALUTAMIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
ACTIVE INGREDIENTBICALUTAMIDE (BICALUTAMIDE) TABLET, FILM COATED [AVKARE, INC.]1
ACTIVE MOIETYBICALUTAMIDE (BICALUTAMIDE) TABLET, FILM COATED [AVKARE, INC.]1
ACTIVE MOIETYBICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]1
ACTIVE INGREDIENTBICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]1
ACTIVE MOIETYBICALUTAMIDE TABLET [REMEDYREPACK INC. ]1
ACTIVE INGREDIENTBICALUTAMIDE TABLET [REMEDYREPACK INC. ]1
ACTIVE MOIETYBICALUTAMIDE TABLET, FILM COATED [AVERA MCKENNAN HOSPITAL]1
ACTIVE INGREDIENTBICALUTAMIDE TABLET, FILM COATED [AVERA MCKENNAN HOSPITAL]1
ACTIVE MOIETYBICALUTAMIDE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]1
ACTIVE INGREDIENTBICALUTAMIDE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]1
ACTIVE MOIETYBICALUTAMIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ACTIVE INGREDIENTBICALUTAMIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ACTIVE MOIETYBICALUTAMIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ACTIVE INGREDIENTBICALUTAMIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ACTIVE MOIETYBICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]1
ACTIVE INGREDIENTBICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]1