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    NDC 50458-0584-52 XARELTO Details

    XARELTO

    XARELTO is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is .

    Product Information

    NDC 50458-0584
    Product ID 50458-584_0aaf0811-077b-1625-e063-6394a90a9177
    Associated GPIs 8337006000B720
    GCN Sequence Number 072904
    GCN Sequence Number Description rivaroxaban TAB DS PK 15 MG-20MG ORAL
    HIC3 M9V
    HIC3 Description DIRECT FACTOR XA INHIBITORS
    GCN 37212
    HICL Sequence Number 035915
    HICL Sequence Number Description RIVAROXABAN
    Brand/Generic Brand
    Proprietary Name XARELTO
    Proprietary Name Suffix n/a
    Non-Proprietary Name Rivaroxaban
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form KIT
    Route n/a
    Active Ingredient Strength n/a
    Active Ingredient Units n/a
    Substance Name n/a
    Labeler Name Janssen Pharmaceuticals, Inc.
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA022406
    Listing Certified Through 2024-12-31

    Package

    NDC 50458-0584-52 (50458058452)

    NDC Package Code 50458-584-52
    Billing NDC 50458058452
    Package 1 KIT in 1 CARTON (50458-584-52) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACK
    Marketing Start Date 2016-11-01
    NDC Exclude Flag N
    Pricing Information N/A