rivaroxaban Oral Tablet

Brand(s)
Xarelto
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Pharmaceuticals, Inc. (2015-09-16)
Oldest Current Product
2011-07-01
License(s)
NDA
RxNORM
ORAL TABLET\RIVAROXABAN
FDAOB
ORAL\TABLET\RIVAROXABAN
SPL Active
ORAL\TABLET, FILM COATED\RIVAROXABAN
SPL Moiety
ORAL\TABLET, FILM COATED\RIVAROXABAN

product(s) by strength(s)

rivaroxaban 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580580XareltoNDAJanssen Pharmaceuticals, Inc.2011-07-01RIVAROXABANORALTABLET, FILM COATEDNDA02240610db92f9-2300-4a80-836b-673e1ae91610

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551541422XareltoNDACardinal Health2011-07-01RIVAROXABANORALTABLET, FILM COATED504580580NDA022406d0e105f6-28f3-45ee-83bd-7d458835242b

rivaroxaban 15 mg oral tablet

product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1504580578XareltoNDAJanssen Pharmaceuticals, Inc.2011-11-04RIVAROXABANORALTABLET, FILM COATEDNDA20243910db92f9-2300-4a80-836b-673e1ae91610
2551541424XareltoNDACardinal Health2011-11-04RIVAROXABANORALTABLET, FILM COATED504580578NDA202439d0e105f6-28f3-45ee-83bd-7d458835242b

rivaroxaban 20 mg oral tablet

product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1504580579XareltoNDAJanssen Pharmaceuticals, Inc.2011-11-05RIVAROXABANORALTABLET, FILM COATEDNDA20243910db92f9-2300-4a80-836b-673e1ae91610
2551541423XareltoNDACardinal Health2011-11-05RIVAROXABANORALTABLET, FILM COATED504580579NDA202439d0e105f6-28f3-45ee-83bd-7d458835242b

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022406XARELTOJANSSEN PHARMACEUTICALS INC2011-07-01p7157456, TREATMENT OF DEEP VEIN THROMBOSIS (DVT)/ TREATMENT OF PULMONARY EMBOLISM (PE), SUBSTANCE
p7592339, TREATMENT OF DEEP VEIN THROMBOSIS (DVT)/ TREATMENT OF PULMONARY EMBOLISM (PE)/ REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM/ PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)/ REDUCTION IN THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM
p7585860, REDUCTION IN THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM
NEW CHEMICAL ENTITY [2016-07-01]
TREATMENT OF PULMONARY EMBOLISM [2015-11-02]
TREATMENT OF DEEP VEIN THROMBOSIS [2015-11-02]
REDUCTION IN RISK FOR DEEP VEIN THROMBOSIS AND THE REDUCTION IN RISK FOR PULMONARY EMBOLISM [2015-11-02]
REDUCE THE RISK OF STROKE AND SYSTEMIC EMBOLISM IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION. [2014-11-04]
NDA022406_001, NDA022406_002, NDA022406_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022406_001RXRIVAROXABAN (10MG)ORALTABLETFalse2011-07-01XARELTO
2NDA022406_002RXRIVAROXABAN (15MG)ORALTABLETFalse2011-11-04XARELTO
3NDA022406_003RXRIVAROXABAN (20MG)ORALTABLETTrue2011-11-04XARELTO

patent(s)

#idexpiration dateapplication(s)
1p7157456 (view patent)2021-02-08NDA022406
2p7585860 (view patent)2020-12-11NDA022406
3p7592339 (view patent)2020-12-11NDA022406

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
110db92f9-2300-4a80-836b-673e1ae91610 (view SPL)These highlights do not include all the information needed to use XARELTO (rivaroxaban) safely and effectively. See full prescribing information for XARELTO.XARELTO (rivaroxaban) tablets, for oral useInitial U.S. Approval: 2011prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2015-09-1617504580578, 504580579, 504580580, 504580584
2d0e105f6-28f3-45ee-83bd-7d458835242b (view SPL)These highlights do not include all the information needed to use XARELTO (rivaroxaban) safely and effectively. See full prescribing information for XARELTO.XARELTO (rivaroxaban) tablets, for oral useInitial U.S. Approval: 2011prescriptionHuman PrescriptionCardinal HealthREPACK2015-08-176551541422, 551541423, 551541424

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII