NDC 55154-1423

Xarelto

Rivaroxaban

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

Product ID55154-1423_39cd791c-ad37-473a-87ab-39ad08ff2c48
NDC55154-1423
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 NameCardinal Health.
Substance NameRIVAROXABAN
Active Ingredient Strength20 mg/1
Pharm ClassesFactor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55154-1423-8

4440 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-1423-8)
Marketing Start Date2011-11-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55154-1423-8 [55154142308]

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

Drug Details

Active Ingredients

IngredientStrength
RIVAROXABAN20 mg/1

OpenFDA Data

SPL SET ID:d0e105f6-28f3-45ee-83bd-7d458835242b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1114198
  • 1114202
  • 1232088
  • 1232082
  • 1232084
  • 1232086
  • UPC Code
  • 0055154142205
  • 0055154142403
  • 0355154142381
  • Pharmacological Class

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

    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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