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    NDC 67877-0538-07 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 Ascend Laboratories, LLC. The primary component is TEMOZOLOMIDE.

    Product Information

    NDC 67877-0538
    Product ID 67877-538_2d0558e6-e623-468d-8478-148f89e24c88
    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 Ascend Laboratories, LLC
    Pharmaceutical Class Alkylating Activity [MoA], Alkylating Drug [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207658
    Listing Certified Through 2024-12-31

    Package

    NDC 67877-0538-07 (67877053807)

    NDC Package Code 67877-538-07
    Billing NDC 67877053807
    Package 5 CAPSULE in 1 BOTTLE (67877-538-07)
    Marketing Start Date 2017-04-28
    NDC Exclude Flag N
    Pricing Information N/A