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    NDC 47335-0893-87 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 Sun Pharmaceutical Industries, Inc.. The primary component is TEMOZOLOMIDE.

    Product Information

    NDC 47335-0893
    Product ID 47335-893_3f33dbae-6f6d-4863-8d02-cc8bd27bc795
    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 Sun Pharmaceutical Industries, Inc.
    Pharmaceutical Class Alkylating Activity [MoA], Alkylating Drug [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA201742
    Listing Certified Through 2024-12-31

    Package

    NDC 47335-0893-87 (47335089387)

    NDC Package Code 47335-893-87
    Billing NDC 47335089387
    Package 1 BOTTLE in 1 CARTON (47335-893-87) / 20 CAPSULE in 1 BOTTLE
    Marketing Start Date 2014-02-13
    NDC Exclude Flag N
    Pricing Information N/A