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    NDC 00054-0604-21 Everolimus 1 mg/1 Details

    Everolimus 1 mg/1

    Everolimus is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is EVEROLIMUS.

    Product Information

    NDC 00054-0604
    Product ID 0054-0604_9b85d4ee-2847-4f7b-ad84-8342e3e8b66f
    Associated GPIs 99404035000335
    GCN Sequence Number 066345
    GCN Sequence Number Description everolimus TABLET 1 MG ORAL
    HIC3 Z2E
    HIC3 Description IMMUNOSUPPRESSIVES
    GCN 28589
    HICL Sequence Number 032975
    HICL Sequence Number Description EVEROLIMUS
    Brand/Generic Generic
    Proprietary Name Everolimus
    Proprietary Name Suffix n/a
    Non-Proprietary Name Everolimus
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 1
    Active Ingredient Units mg/1
    Substance Name EVEROLIMUS
    Labeler Name Hikma Pharmaceuticals USA Inc.
    Pharmaceutical Class Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA206133
    Listing Certified Through 2024-12-31

    Package

    NDC 00054-0604-21 (00054060421)

    NDC Package Code 0054-0604-21
    Billing NDC 00054060421
    Package 60 TABLET in 1 BOTTLE (0054-0604-21)
    Marketing Start Date 2021-11-18
    NDC Exclude Flag N
    Pricing Information N/A