Search by Drug Name or NDC

    NDC 65162-0986-09 Lamotrigine 200 mg/1 Details

    Lamotrigine 200 mg/1

    Lamotrigine is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is LAMOTRIGINE.

    Product Information

    NDC 65162-0986
    Product ID 65162-986_4a93bf08-dc27-4901-8dfa-614b120bb970
    Associated GPIs 72600040007540
    GCN Sequence Number 065253
    GCN Sequence Number Description lamotrigine TAB ER 24 200 MG ORAL
    HIC3 H4B
    HIC3 Description ANTICONVULSANTS
    GCN 24739
    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, FILM COATED, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 200
    Active Ingredient Units mg/1
    Substance Name LAMOTRIGINE
    Labeler Name Amneal Pharmaceuticals LLC
    Pharmaceutical Class Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207497
    Listing Certified Through 2022-12-31

    Package

    NDC 65162-0986-09 (65162098609)

    NDC Package Code 65162-986-09
    Billing NDC 65162098609
    Package 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-986-09)
    Marketing Start Date 2018-11-30
    NDC Exclude Flag N
    Pricing Information N/A