ELIQUIS
These highlights do not include all the information needed to use ELIQUIS safely and effectively. See full prescribing information for ELIQUIS. ELIQUIS (apixaban) tablets, for oral useInitial U.S. Approval: 2012
Approved
Approval ID
dbf07ee1-d09a-4d12-9812-58a76e96ef10
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 14, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
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 Code63629-7747
Application NumberNDA202155
Product Classification
M
Marketing Category
C73594
G
Generic Name
apixaban
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2022
FDA Product Classification
INGREDIENTS (11)
APIXABANActive
Quantity: 5 mg in 1 1
Code: 3Z9Y7UWC1J
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT