ERLEADA
These highlights do not include all the information needed to use ERLEADA safely and effectively. See full prescribing information for ERLEADA. ERLEADA (apalutamide) tablets, for oral use Initial U.S. Approval – 2018
Approved
Approval ID
d1cda4f7-cb33-46ea-b9ac-431f6452b1a5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2024
Manufacturers
FDA
Janssen Products, LP
DUNS: 804684207
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Apalutamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59676-604
Application NumberNDA210951
Product Classification
M
Marketing Category
C73594
G
Generic Name
Apalutamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MPA.S)Inactive
Code: 24P2YXD2PW
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10N
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)Inactive
Code: 23ZQ42JZZH
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
APALUTAMIDEActive
Quantity: 240 mg in 1 1
Code: 4T36H88UA7
Classification: ACTIB
Apalutamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59676-600
Application NumberNDA210951
Product Classification
M
Marketing Category
C73594
G
Generic Name
Apalutamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MPA.S)Inactive
Code: 24P2YXD2PW
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
APALUTAMIDEActive
Quantity: 60 mg in 1 1
Code: 4T36H88UA7
Classification: ACTIB