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    NDC 00121-2024-95 Lacosamide 100 mg/10mL Details

    Lacosamide 100 mg/10mL

    Lacosamide is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PAI Holdings, LLC. The primary component is LACOSAMIDE.

    Product Information

    NDC 00121-2024
    Product ID 0121-2024_597d3a63-1ba4-4680-9329-dd60ef73fbaf
    Associated GPIs
    GCN Sequence Number 066386
    GCN Sequence Number Description lacosamide SOLUTION 10 MG/ML ORAL
    HIC3 H4B
    HIC3 Description ANTICONVULSANTS
    GCN 28643
    HICL Sequence Number 035872
    HICL Sequence Number Description LACOSAMIDE
    Brand/Generic Generic
    Proprietary Name Lacosamide
    Proprietary Name Suffix n/a
    Non-Proprietary Name Lacosamide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 100
    Active Ingredient Units mg/10mL
    Substance Name LACOSAMIDE
    Labeler Name PAI Holdings, LLC
    Pharmaceutical Class Decreased Central Nervous System Disorganized Electrical Activity [PE]
    DEA Schedule CV
    Marketing Category ANDA
    Application Number ANDA216151
    Listing Certified Through 2024-12-31

    Package

    NDC 00121-2024-95 (00121202495)

    NDC Package Code 0121-2024-95
    Billing NDC 00121202495
    Package 1 TRAY in 1 TRAY (0121-2024-95) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-2024-10)
    Marketing Start Date 2023-04-28
    NDC Exclude Flag N
    Pricing Information N/A