abiraterone acetate
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
ba32c453-a231-452a-a6d9-b3e57afb2e75
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 19, 2022
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
Products 2
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 Code68462-135
Application NumberANDA209227
Product Classification
M
Marketing Category
C73584
G
Generic Name
abiraterone acetate
Product Specifications
Route of AdministrationORAL
Effective DateMay 19, 2022
FDA Product Classification
INGREDIENTS (8)
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
abiraterone acetateActive
Quantity: 250 mg in 1 1
Code: EM5OCB9YJ6
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
abiraterone acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-882
Application NumberANDA209227
Product Classification
M
Marketing Category
C73584
G
Generic Name
abiraterone acetate
Product Specifications
Route of AdministrationORAL
Effective DateMay 19, 2022
FDA Product Classification
INGREDIENTS (14)
abiraterone acetateActive
Quantity: 500 mg in 1 1
Code: EM5OCB9YJ6
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT