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    NDC 47335-0321-08 Memantine Hydrochloride 5 mg/1 Details

    Memantine Hydrochloride 5 mg/1

    Memantine Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is MEMANTINE HYDROCHLORIDE.

    Product Information

    NDC 47335-0321
    Product ID 47335-321_81ca8cbf-7854-43a2-bd0b-1dbaf4709a42
    Associated GPIs 62053550100320
    GCN Sequence Number 053324
    GCN Sequence Number Description memantine HCl TABLET 5 MG ORAL
    HIC3 H1A
    HIC3 Description ALZHEIMER'S THERAPY, NMDA RECEPTOR ANTAGONISTS
    GCN 20773
    HICL Sequence Number 013778
    HICL Sequence Number Description MEMANTINE HCL
    Brand/Generic Generic
    Proprietary Name Memantine Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Memantine Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/1
    Substance Name MEMANTINE HYDROCHLORIDE
    Labeler Name Sun Pharmaceutical Industries, Inc.
    Pharmaceutical Class N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA090058
    Listing Certified Through 2024-12-31

    Package

    NDC 47335-0321-08 (47335032108)

    NDC Package Code 47335-321-08
    Billing NDC 47335032108
    Package 100 TABLET, FILM COATED in 1 BOTTLE (47335-321-08)
    Marketing Start Date 2015-07-11
    NDC Exclude Flag N
    Pricing Information N/A