FDA.reportPublic FDA data

Application 202439

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XARELTORIVAROXABANTABLET;ORAL10MGNoNo
002XARELTORIVAROXABANTABLET;ORAL15MGNoNo
003XARELTORIVAROXABANTABLET;ORAL20MGNoNo
004XARELTORIVAROXABANTABLET;ORAL2.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XareltoRIVAROXABANCardinal Health 107, LLCd0e105f6-28f3-45ee-83bd-7d458835242b2026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 55154-1423
ndc (product): 55154-1424
XareltoRIVAROXABANJanssen Pharmaceuticals, Inc.10db92f9-2300-4a80-836b-673e1ae916102026-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 50458-578
ndc (product): 50458-579
ndc (product): 50458-577
XareltoRIVAROXABANA-S Medication Solutionse76bf2cf-a8b8-4471-a8ce-57c918b11a482024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 50090-4468
XARELTORIVAROXABANA-S Medication Solutions3e95389b-0a93-4560-98c5-02637fb2600f2023-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 50090-3639

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 69 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3639XareltorivaroxabanA-S Medication SolutionsNDACurrent
50090-4468XareltorivaroxabanA-S Medication SolutionsNDACurrent
50090-4468XareltorivaroxabanA-S Medication SolutionsNDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-577XARELTOrivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-578XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
50458-579XareltorivaroxabanJanssen Pharmaceuticals, Inc.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health 107, LLCNDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health 107, LLCNDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1423XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health 107, LLCNDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health 107, LLCNDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent
55154-1424XareltorivaroxabanCardinal Health.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70375SUPPL2022-03-02
70374SUPPL2022-03-02
70356SUPPL2022-03-02
70093SUPPL2022-02-04
68460SUPPL2021-08-25
68459SUPPL2021-08-25
68454SUPPL2021-08-25
66026SUPPL2021-01-29
66025SUPPL2021-01-29
66022SUPPL2021-01-29
62123SUPPL2020-03-11
62122SUPPL2020-03-11
62116SUPPL2020-03-11
61024SUPPL2019-11-22
61023SUPPL2019-11-22
60902SUPPL2019-11-19
60565SUPPL2019-10-15
60544SUPPL2019-10-11
59866SUPPL2019-08-28
59845SUPPL2019-08-27
57534SUPPL2019-02-13
57412SUPPL2019-02-04
55878SUPPL2018-10-11
55047SUPPL2018-07-30
54835SUPPL2018-07-06
54763SUPPL2018-07-05
52546SUPPL2018-02-09
52527SUPPL2018-02-09
47841SUPPL2017-04-03
47786SUPPL2017-03-30
47281SUPPL2017-02-22
45541SUPPL2016-10-14
45273SUPPL2016-09-08
40185SUPPL2016-05-09
32262SUPPL2016-05-09
10050SUPPL2015-09-14
40184SUPPL2015-09-11
43402ORIG2014-06-03
32260ORIG2014-06-03
19348ORIG2014-06-03
32261SUPPL2014-02-13
19349SUPPL2013-08-09
10049SUPPL2013-08-08