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    NDC 70518-1953-00 topiramate 100 mg/1 Details

    topiramate 100 mg/1

    topiramate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by REMEDYREPACK INC.. The primary component is TOPIRAMATE.

    Product Information

    NDC 70518-1953
    Product ID 70518-1953_fe3f9956-1fe4-81d4-e053-6294a90a4e9e
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name topiramate
    Proprietary Name Suffix n/a
    Non-Proprietary Name topiramate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 100
    Active Ingredient Units mg/1
    Substance Name TOPIRAMATE
    Labeler Name REMEDYREPACK INC.
    Pharmaceutical Class Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA078235
    Listing Certified Through 2024-12-31

    Package

    NDC 70518-1953-00 (70518195300)

    NDC Package Code 70518-1953-0
    Billing NDC 70518195300
    Package 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1953-0)
    Marketing Start Date 2019-03-13
    NDC Exclude Flag N
    Pricing Information N/A