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    NDC 50458-0575-01 Xarelto 155 mg/1 Details

    Xarelto 155 mg/1

    Xarelto is a ORAL GRANULE, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is RIVAROXABAN.

    Product Information

    NDC 50458-0575
    Product ID 50458-575_0aaf0811-077b-1625-e063-6394a90a9177
    Associated GPIs 83370060001920
    GCN Sequence Number 082570
    GCN Sequence Number Description rivaroxaban SUSP RECON 1 MG/ML ORAL
    HIC3 M9V
    HIC3 Description DIRECT FACTOR XA INHIBITORS
    GCN 50027
    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 GRANULE, FOR SUSPENSION
    Route ORAL
    Active Ingredient Strength 155
    Active Ingredient Units mg/1
    Substance Name RIVAROXABAN
    Labeler Name Janssen Pharmaceuticals, Inc.
    Pharmaceutical Class Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA215859
    Listing Certified Through 2024-12-31

    Package

    NDC 50458-0575-01 (50458057501)

    NDC Package Code 50458-575-01
    Billing NDC 50458057501
    Package 1 BOTTLE in 1 CARTON (50458-575-01) / 1 GRANULE, FOR SUSPENSION in 1 BOTTLE
    Marketing Start Date 2021-12-01
    NDC Exclude Flag N
    Pricing Information N/A