"57894-100-60" National Drug Code (NDC)

NDC Code	57894-100-60
Package Description	1 BOTTLE in 1 CARTON (57894-100-60) / 60 TABLET, FILM COATED in 1 BOTTLE
Product NDC	57894-100
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Akeega
Non-Proprietary Name	Niraparib Tosylate Monohydrate And Abiraterone Acetate
Dosage Form	TABLET, FILM COATED
Usage	ORAL
Start Marketing Date	20230811
Marketing Category Name	NDA
Application Number	NDA216793
Manufacturer	Janssen Biotech, Inc.
Substance Name	ABIRATERONE ACETATE; NIRAPARIB TOSYLATE MONOHYDRATE
Strength	500; 100
Strength Unit	mg/1; mg/1
Pharmacy Classes	Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]