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    NDC 68382-0756-96 temozolomide 250 mg/1 Details

    temozolomide 250 mg/1

    temozolomide is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is TEMOZOLOMIDE.

    Product Information

    NDC 68382-0756
    Product ID 68382-756_2da71848-9a09-45b2-820e-c43f37b0fe3e
    Associated GPIs 21104070000150
    GCN Sequence Number 043013
    GCN Sequence Number Description temozolomide CAPSULE 250 MG ORAL
    HIC3 V1A
    HIC3 Description ANTINEOPLASTIC - ALKYLATING AGENTS
    GCN 92933
    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 250
    Active Ingredient Units mg/1
    Substance Name TEMOZOLOMIDE
    Labeler Name Zydus Pharmaceuticals USA Inc.
    Pharmaceutical Class Alkylating Activity [MoA], Alkylating Drug [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA206750
    Listing Certified Through 2024-12-31

    Package

    NDC 68382-0756-96 (68382075696)

    NDC Package Code 68382-756-96
    Billing NDC 68382075696
    Package 5 CAPSULE in 1 BOTTLE (68382-756-96)
    Marketing Start Date 2017-10-26
    NDC Exclude Flag N
    Pricing Information N/A