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    NDC 62559-0921-51 Temozolomide 20 mg/1 Details

    Temozolomide 20 mg/1

    Temozolomide is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by ANI Pharmaceuticals, Inc.. The primary component is TEMOZOLOMIDE.

    Product Information

    NDC 62559-0921
    Product ID 62559-921_ea20ab6a-6558-4114-8983-c8df85adff0a
    Associated GPIs 21104070000120
    GCN Sequence Number 043011
    GCN Sequence Number Description temozolomide CAPSULE 20 MG ORAL
    HIC3 V1A
    HIC3 Description ANTINEOPLASTIC - ALKYLATING AGENTS
    GCN 92903
    HICL Sequence Number 020355
    HICL Sequence Number Description TEMOZOLOMIDE
    Brand/Generic Generic
    Proprietary Name Temozolomide
    Proprietary Name Suffix n/a
    Non-Proprietary Name Temozolomide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 20
    Active Ingredient Units mg/1
    Substance Name TEMOZOLOMIDE
    Labeler Name ANI Pharmaceuticals, Inc.
    Pharmaceutical Class Alkylating Activity [MoA], Alkylating Drug [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203490
    Listing Certified Through n/a

    Package

    NDC 62559-0921-51 (62559092151)

    NDC Package Code 62559-921-51
    Billing NDC 62559092151
    Package 1 BOTTLE, GLASS in 1 CARTON (62559-921-51) / 5 CAPSULE in 1 BOTTLE, GLASS
    Marketing Start Date 2020-11-16
    NDC Exclude Flag N
    Pricing Information N/A