NDC 50090-4468

Xarelto

Rivaroxaban

Xarelto is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Rivaroxaban.

Product ID50090-4468_8ca77452-ec4d-49c5-b331-e85d586d3f81
NDC50090-4468
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 NameA-S Medication Solutions
Substance NameRIVAROXABAN
Active Ingredient Strength20 mg/1
Pharm ClassesFactor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50090-4468-0

90 TABLET, FILM COATED in 1 BOTTLE (50090-4468-0)
Marketing Start Date2019-08-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-4468-0 [50090446800]

Xarelto TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202439
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-16

Drug Details

Active Ingredients

IngredientStrength
RIVAROXABAN20 mg/1

OpenFDA Data

SPL SET ID:e76bf2cf-a8b8-4471-a8ce-57c918b11a48
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1232088
  • 1232086
  • Pharmacological Class

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

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