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    NDC 68462-0494-30 deferasirox 125 mg/1 Details

    deferasirox 125 mg/1

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

    Product Information

    NDC 68462-0494
    Product ID 68462-494_1595b336-a89a-49bc-b0b8-13c204726f13
    Associated GPIs 93100025007320
    GCN Sequence Number 060046
    GCN Sequence Number Description deferasirox TAB DISPER 125 MG ORAL
    HIC3 C8A
    HIC3 Description METALLIC POISON,AGENTS TO TREAT
    GCN 26042
    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 125
    Active Ingredient Units mg/1
    Substance Name DEFERASIROX
    Labeler Name Glenmark Pharmaceuticals Inc., USA
    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 ANDA209433
    Listing Certified Through 2025-12-31

    Package

    NDC 68462-0494-30 (68462049430)

    NDC Package Code 68462-494-30
    Billing NDC 68462049430
    Package 30 TABLET, FOR SUSPENSION in 1 BOTTLE (68462-494-30)
    Marketing Start Date 2020-01-06
    NDC Exclude Flag N
    Pricing Information N/A