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    NDC 13925-0540-12 Memantine Hydrochloride 2 mg/mL Details

    Memantine Hydrochloride 2 mg/mL

    Memantine Hydrochloride is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Seton Pharmaceuticals. The primary component is MEMANTINE HYDROCHLORIDE.

    Product Information

    NDC 13925-0540
    Product ID 13925-540_2169d573-cb80-451b-926f-bcd46948f8c0
    Associated GPIs 62053550102020
    GCN Sequence Number 058996
    GCN Sequence Number Description memantine HCl SOLUTION 2 MG/ML ORAL
    HIC3 H1A
    HIC3 Description ALZHEIMER'S THERAPY, NMDA RECEPTOR ANTAGONISTS
    GCN 24545
    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 Oral
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 2
    Active Ingredient Units mg/mL
    Substance Name MEMANTINE HYDROCHLORIDE
    Labeler Name Seton Pharmaceuticals
    Pharmaceutical Class N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA210319
    Listing Certified Through 2024-12-31

    Package

    NDC 13925-0540-12 (13925054012)

    NDC Package Code 13925-540-12
    Billing NDC 13925054012
    Package 360 mL in 1 BOTTLE (13925-540-12)
    Marketing Start Date 2021-05-19
    NDC Exclude Flag N
    Pricing Information N/A