apixaban
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use APIXABAN TABLETS safely and effectively. See full prescribing information for APIXABAN TABLETS. APIXABAN tablets, for oral use Initial U.S. Approval: 2012
Approved
Approval ID
095a08ac-cf0e-497e-a682-ddef38d6b29c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2021
Manufacturers
FDA
Indoco Remedies Limited
DUNS: 650445950
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
apixaban
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14445-149
Application NumberANDA209898
Product Classification
M
Marketing Category
C73584
G
Generic Name
apixaban
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2021
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
APIXABANActive
Quantity: 2.5 mg in 1 1
Code: 3Z9Y7UWC1J
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
apixaban
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14445-150
Application NumberANDA209898
Product Classification
M
Marketing Category
C73584
G
Generic Name
apixaban
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2021
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
APIXABANActive
Quantity: 5 mg in 1 1
Code: 3Z9Y7UWC1J
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT