NDC 50458-577

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 ID50458-577_271c2898-67e5-11e9-974e-d1c20099106d
NDC50458-577
Product TypeHuman Prescription Drug
Proprietary NameXARELTO
Generic NameRivaroxaban
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-10-09
Marketing CategoryNDA / NDA
Application NumberNDA202439
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameRIVAROXABAN
Active Ingredient Strength3 mg/1
Pharm ClassesFactor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50458-577-10

10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-577-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK (50458-577-01)
Marketing Start Date2018-10-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-577-60 [50458057760]

XARELTO TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202439
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-09

NDC 50458-577-18 [50458057718]

XARELTO TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202439
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-09

NDC 50458-577-01 [50458057701]

XARELTO TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202439
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-13

NDC 50458-577-10 [50458057710]

XARELTO TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202439
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-09

NDC 50458-577-14 [50458057714]

XARELTO TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202439
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-09

Drug Details

Active Ingredients

IngredientStrength
RIVAROXABAN2.5 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

    50458057760 XARELTO 2.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    50458057718 XARELTO 2.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    50458057710 XARELTO 2.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    50458057701 XARELTO 2.5 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.