NDC 50458-579

Xarelto

Rivaroxaban

Xarelto is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Rivaroxaban.

Product ID50458-579_271c2898-67e5-11e9-974e-d1c20099106d
NDC50458-579
Product TypeHuman Prescription Drug
Proprietary NameXarelto
Generic NameRivaroxaban
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-11-05
Marketing CategoryNDA / NDA
Application NumberNDA202439
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameRIVAROXABAN
Active Ingredient Strength20 mg/1
Pharm ClassesFactor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50458-579-07

7 TABLET, FILM COATED in 1 BOTTLE (50458-579-07)
Marketing Start Date2016-09-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-579-01 [50458057901]

Xarelto TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202439
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-25

NDC 50458-579-90 [50458057990]

Xarelto TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202439
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-05

NDC 50458-579-30 [50458057930]

Xarelto TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202439
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-05

NDC 50458-579-10 [50458057910]

Xarelto TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202439
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-05

NDC 50458-579-99 [50458057999]

Xarelto TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202439
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-11-05

NDC 50458-579-07 [50458057907]

Xarelto TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202439
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-20

NDC 50458-579-89 [50458057989]

Xarelto TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202439
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-06

Drug Details

Active Ingredients

IngredientStrength
RIVAROXABAN20 mg/1

OpenFDA Data

SPL SET ID:10db92f9-2300-4a80-836b-673e1ae91610
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1114198
  • 1549683
  • 1114202
  • 1549682
  • 1232088
  • 2059015
  • 2059017
  • 1232082
  • 1232084
  • 1232086
  • Pharmacological Class

    • Factor Xa Inhibitors [MoA]
    • Factor Xa Inhibitor [EPC]

    Medicade Reported Pricing

    50458057990 XARELTO 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    50458057989 XARELTO 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    50458057930 XARELTO 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    50458057910 XARELTO 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Xarelto" or generic name "Rivaroxaban"

    NDCBrand NameGeneric Name
    50090-3625Xareltorivaroxaban
    50090-3639Xareltorivaroxaban
    50090-4468Xareltorivaroxaban
    50090-4469Xareltorivaroxaban
    50458-575Xareltorivaroxaban
    50458-577XARELTOrivaroxaban
    50458-578Xareltorivaroxaban
    50458-579Xareltorivaroxaban
    50458-580XareltoXarelto
    50458-584XARELTOXARELTO
    55154-1423XareltoXarelto
    55154-1424XareltoXarelto
    55154-1422XareltoXarelto

    Trademark Results [Xarelto]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XARELTO
    XARELTO
    78152154 2804753 Live/Registered
    Bayer Aktiengesellschaft
    2002-08-08
    XARELTO
    XARELTO
    77752463 4105934 Live/Registered
    Bayer Aktiengesellschaft
    2009-06-04

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