Xarelto
These highlights do not include all the information needed to use XARELTOsafely and effectively. See full prescribing information for XARELTO. XARELTO (rivaroxaban) tablets, for oral use Initial U.S. Approval: 2011
Approved
Approval ID
65727928-9421-4df8-bff2-f72a9cc78069
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2021
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
NDC Product Code50090-4469
Application NumberNDA022406
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 19, 2019
Generic Namerivaroxaban
INGREDIENTS (10)
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
RIVAROXABANActive
Quantity: 10 mg in 1 1
Code: 9NDF7JZ4M3
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT