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    NDC 00078-0470-15 Exjade 500 mg/1 Details

    Exjade 500 mg/1

    Exjade is a ORAL TABLET, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is DEFERASIROX.

    Product Information

    NDC 00078-0470
    Product ID 0078-0470_7dc3e0ba-efd7-4d96-99d5-199df65bcd0b
    Associated GPIs 93100025007340
    GCN Sequence Number 060048
    GCN Sequence Number Description deferasirox TAB DISPER 500 MG ORAL
    HIC3 C8A
    HIC3 Description METALLIC POISON,AGENTS TO TREAT
    GCN 26044
    HICL Sequence Number 033337
    HICL Sequence Number Description DEFERASIROX
    Brand/Generic Brand
    Proprietary Name Exjade
    Proprietary Name Suffix n/a
    Non-Proprietary Name deferasirox
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FOR SUSPENSION
    Route ORAL
    Active Ingredient Strength 500
    Active Ingredient Units mg/1
    Substance Name DEFERASIROX
    Labeler Name Novartis Pharmaceuticals Corporation
    Pharmaceutical Class Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021882
    Listing Certified Through 2024-12-31

    Package

    NDC 00078-0470-15 (00078047015)

    NDC Package Code 0078-0470-15
    Billing NDC 00078047015
    Package 30 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0470-15)
    Marketing Start Date 2005-11-30
    NDC Exclude Flag N
    Pricing Information N/A