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    NDC 42806-0373-30 Deferasirox Oral Granules 360 mg/1 Details

    Deferasirox Oral Granules 360 mg/1

    Deferasirox Oral Granules is a ORAL GRANULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by EPIC PHARMA, LLC. The primary component is DEFERASIROX.

    Product Information

    NDC 42806-0373
    Product ID 42806-373_032860cb-ab2e-4fa7-aa43-672dee85e481
    Associated GPIs
    GCN Sequence Number 077443
    GCN Sequence Number Description deferasirox GRAN PACK 360 MG ORAL
    HIC3 C8A
    HIC3 Description METALLIC POISON,AGENTS TO TREAT
    GCN 43466
    HICL Sequence Number 033337
    HICL Sequence Number Description DEFERASIROX
    Brand/Generic Generic
    Proprietary Name Deferasirox Oral Granules
    Proprietary Name Suffix n/a
    Non-Proprietary Name deferasirox
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form GRANULE
    Route ORAL
    Active Ingredient Strength 360
    Active Ingredient Units mg/1
    Substance Name DEFERASIROX
    Labeler Name EPIC PHARMA, LLC
    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 ANDA214559
    Listing Certified Through 2024-12-31

    Package

    NDC 42806-0373-30 (42806037330)

    NDC Package Code 42806-373-30
    Billing NDC 42806037330
    Package 30 PACKET in 1 CARTON (42806-373-30) / 1 GRANULE in 1 PACKET
    Marketing Start Date 2022-10-06
    NDC Exclude Flag N
    Pricing Information N/A