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    NDC 69452-0161-13 Deferasirox 500 mg/1 Details

    Deferasirox 500 mg/1

    Deferasirox is a ORAL TABLET, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bionpharma Inc.. The primary component is DEFERASIROX.

    Product Information

    NDC 69452-0161
    Product ID 69452-161_f1ee8cb0-3294-a9a9-e053-2a95a90a1061
    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 Generic
    Proprietary Name Deferasirox
    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 Bionpharma Inc.
    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 ANDA
    Application Number ANDA210920
    Listing Certified Through 2024-12-31

    Package

    NDC 69452-0161-13 (69452016113)

    NDC Package Code 69452-161-13
    Billing NDC 69452016113
    Package 30 TABLET, FOR SUSPENSION in 1 BOTTLE (69452-161-13)
    Marketing Start Date 2018-09-28
    NDC Exclude Flag N
    Pricing Information N/A