Search by Drug Name or NDC

    NDC 69238-1704-03 deferasirox 360 mg/1 Details

    deferasirox 360 mg/1

    deferasirox is a ORAL GRANULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals NY LLC. The primary component is DEFERASIROX.

    Product Information

    NDC 69238-1704
    Product ID 69238-1704_cd673946-3321-416a-9ea1-06b8a23f1329
    Associated GPIs 93100025003040
    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
    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 Amneal Pharmaceuticals NY 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 ANDA214194
    Listing Certified Through 2024-12-31

    Package

    NDC 69238-1704-03 (69238170403)

    NDC Package Code 69238-1704-3
    Billing NDC 69238170403
    Package 30 PACKET in 1 CARTON (69238-1704-3) / 1 GRANULE in 1 PACKET (69238-1704-1)
    Marketing Start Date 2021-02-09
    NDC Exclude Flag N
    Pricing Information N/A