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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

d0e105f6-28f3-45ee-83bd-7d458835242b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 31, 2023

Manufacturers
FDA

Cardinal Health 107, LLC

DUNS: 118546603

Products 3

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 Code55154-1423
Application NumberNDA202439
Product Classification
M
Marketing Category
C73594
G
Generic Name
rivaroxaban
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2021
FDA Product Classification

INGREDIENTS (10)

croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
rivaroxabanActive
Quantity: 20 mg in 1 1
Code: 9NDF7JZ4M3
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT

rivaroxaban

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55154-1424
Application NumberNDA202439
Product Classification
M
Marketing Category
C73594
G
Generic Name
rivaroxaban
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2021
FDA Product Classification

INGREDIENTS (10)

rivaroxabanActive
Quantity: 15 mg in 1 1
Code: 9NDF7JZ4M3
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
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

rivaroxaban

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55154-1422
Application NumberNDA022406
Product Classification
M
Marketing Category
C73594
G
Generic Name
rivaroxaban
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2021
FDA Product Classification

INGREDIENTS (10)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
rivaroxabanActive
Quantity: 10 mg in 1 1
Code: 9NDF7JZ4M3
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT

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