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    NDC 00085-3004-04 TEMODAR 5 mg/1 Details

    TEMODAR 5 mg/1

    TEMODAR is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Merck Sharp & Dohme LLC. The primary component is TEMOZOLOMIDE.

    Product Information

    NDC 00085-3004
    Product ID 0085-3004_377e34ef-4f0a-4edc-8353-a9967683b580
    Associated GPIs 21104070000110
    GCN Sequence Number 043010
    GCN Sequence Number Description temozolomide CAPSULE 5 MG ORAL
    HIC3 V1A
    HIC3 Description ANTINEOPLASTIC - ALKYLATING AGENTS
    GCN 92893
    HICL Sequence Number 020355
    HICL Sequence Number Description TEMOZOLOMIDE
    Brand/Generic Brand
    Proprietary Name TEMODAR
    Proprietary Name Suffix n/a
    Non-Proprietary Name Temozolomide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name TEMOZOLOMIDE
    Labeler Name Merck Sharp & Dohme LLC
    Pharmaceutical Class Alkylating Activity [MoA], Alkylating Drug [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021029
    Listing Certified Through 2024-12-31

    Package

    NDC 00085-3004-04 (00085300404)

    NDC Package Code 0085-3004-04
    Billing NDC 00085300404
    Package 14 PACKET in 1 CARTON (0085-3004-04) / 1 CAPSULE in 1 PACKET (0085-3004-05)
    Marketing Start Date 1999-08-11
    NDC Exclude Flag N
    Pricing Information N/A