Abiraterone Acetate
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for ABIRATERONE ACETATE TABLETS. tablets, for oral use Initial U.S. Approval: 2011
Approved
Approval ID
39434b24-bf64-f5c9-fbb6-b0d225099424
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2023
Manufacturers
FDA
NorthStar Rx LLC
DUNS: 830546433
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Abiraterone Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-963
Application NumberANDA208416
Product Classification
M
Marketing Category
C73584
G
Generic Name
Abiraterone Acetate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 26, 2023
FDA Product Classification
INGREDIENTS (11)
ABIRATERONE ACETATEActive
Quantity: 250 mg in 1 1
Code: EM5OCB9YJ6
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT