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    NDC 68462-0228-10 Lamotrigine 5 mg/1 Details

    Lamotrigine 5 mg/1

    Lamotrigine is a ORAL TABLET, CHEWABLE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., USA. The primary component is LAMOTRIGINE.

    Product Information

    NDC 68462-0228
    Product ID 68462-228_4b6c4092-c0df-45a4-a1ab-9fcc9b5b8ded
    Associated GPIs 72600040000510
    GCN Sequence Number 021935
    GCN Sequence Number Description lamotrigine TB CHW DSP 5 MG ORAL
    HIC3 H4B
    HIC3 Description ANTICONVULSANTS
    GCN 64323
    HICL Sequence Number 007378
    HICL Sequence Number Description LAMOTRIGINE
    Brand/Generic Generic
    Proprietary Name Lamotrigine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Lamotrigine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, CHEWABLE
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name LAMOTRIGINE
    Labeler Name Glenmark Pharmaceuticals Inc., USA
    Pharmaceutical Class Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA079099
    Listing Certified Through 2025-12-31

    Package

    NDC 68462-0228-10 (68462022810)

    NDC Package Code 68462-228-10
    Billing NDC 68462022810
    Package 1000 TABLET, CHEWABLE in 1 BOTTLE (68462-228-10)
    Marketing Start Date 2009-02-19
    NDC Exclude Flag N
    Pricing Information N/A