Abiraterone
These highlights do not include all the information needed to use ABIRATERONE ACETATE TABLETS safely and effectively. See full prescribing information for ABIRATERONE ACETATE TABLETS. ABIRATERONE ACETATE tablets, for oral useInitial U.S. Approval: 2011
Approved
Approval ID
0ef857ee-2bfc-4d27-a417-ad58fc3a6ff6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2023
Manufacturers
FDA
CivicaScript, LLC
DUNS: 117941593
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 Code82249-010
Application NumberANDA208339
Product Classification
M
Marketing Category
C73584
G
Generic Name
Abiraterone acetate
Product Specifications
Route of AdministrationORAL
Effective DateJune 27, 2022
FDA Product Classification
INGREDIENTS (9)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ABIRATERONE ACETATEActive
Quantity: 250 mg in 1 1
Code: EM5OCB9YJ6
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT