Xarelto
These highlights do not include all the information needed to use XARELTO safely and effectively. See full prescribing information for XARELTO. XARELTO (rivaroxaban) tablets, for oral use XARELTO (rivaroxaban) for oral suspension Initial U.S. Approval: 2011
Approved
Approval ID
7e9ab975-db2f-423c-a089-bc5a73313609
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
rivaroxaban
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-3625
Application NumberNDA022406
Product Classification
M
Marketing Category
C73594
G
Generic Name
rivaroxaban
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (10)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
RIVAROXABANActive
Quantity: 10 mg in 1 1
Code: 9NDF7JZ4M3
Classification: ACTIB