CASODEX
These 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 useInitial U.S. Approval: 1995
Approved
Approval ID
5bd7e54e-8497-4bc4-8964-151943db0626
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 27, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bicalutamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4503
Application NumberNDA020498
Product Classification
M
Marketing Category
C73594
G
Generic Name
Bicalutamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2012
FDA Product Classification
INGREDIENTS (8)
BICALUTAMIDEActive
Quantity: 50 mg in 1 1
Code: A0Z3NAU9DP
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT