AKEEGA
These highlights do not include all the information needed to use AKEEGA safely and effectively. See full prescribing information for AKEEGA. AKEEGA™ (niraparib and abiraterone acetate) tablets, for oral use Initial U.S. Approval: 2023
Approved
Approval ID
8245a990-3268-4613-b5c5-9537858a1eb9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2023
Manufacturers
FDA
Janssen Biotech, Inc.
DUNS: 099091753
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57894-100
Application NumberNDA216793
Product Classification
M
Marketing Category
C73594
G
Generic Name
NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2023
FDA Product Classification
INGREDIENTS (15)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10N
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
NIRAPARIB TOSYLATE MONOHYDRATEActive
Quantity: 100 mg in 1 1
Code: 195Q483UZD
Classification: ACTIM
ABIRATERONE ACETATEActive
Quantity: 500 mg in 1 1
Code: EM5OCB9YJ6
Classification: ACTIB
NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57894-050
Application NumberNDA216793
Product Classification
M
Marketing Category
C73594
G
Generic Name
NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2023
FDA Product Classification
INGREDIENTS (15)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
NIRAPARIB TOSYLATE MONOHYDRATEActive
Quantity: 50 mg in 1 1
Code: 195Q483UZD
Classification: ACTIM
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10N
Classification: IACT
ABIRATERONE ACETATEActive
Quantity: 500 mg in 1 1
Code: EM5OCB9YJ6
Classification: ACTIB