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    NDC 63459-0416-30 GABITRIL 16 mg/1 Details

    GABITRIL 16 mg/1

    GABITRIL is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cephalon, LLC. The primary component is TIAGABINE HYDROCHLORIDE.

    Product Information

    NDC 63459-0416
    Product ID 63459-416_d7af694a-3367-452e-aeaa-5a529d1dd364
    Associated GPIs 72170070100320
    GCN Sequence Number 034739
    GCN Sequence Number Description tiagabine HCl TABLET 16 MG ORAL
    HIC3 H4B
    HIC3 Description ANTICONVULSANTS
    GCN 37982
    HICL Sequence Number 015773
    HICL Sequence Number Description TIAGABINE HCL
    Brand/Generic Brand
    Proprietary Name GABITRIL
    Proprietary Name Suffix n/a
    Non-Proprietary Name Tiagabine Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 16
    Active Ingredient Units mg/1
    Substance Name TIAGABINE HYDROCHLORIDE
    Labeler Name Cephalon, LLC
    Pharmaceutical Class Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA020646
    Listing Certified Through n/a

    Package

    NDC 63459-0416-30 (63459041630)

    NDC Package Code 63459-416-30
    Billing NDC 63459041630
    Package 30 TABLET, FILM COATED in 1 BOTTLE (63459-416-30)
    Marketing Start Date 2010-02-08
    NDC Exclude Flag N
    Pricing Information N/A