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    NDC 69315-0318-20 Lacosamide 10 mg/mL Details

    Lacosamide 10 mg/mL

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

    Product Information

    NDC 69315-0318
    Product ID 69315-318_a6251270-fa62-4c7c-9bb4-ca0d88ec77b3
    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 10
    Active Ingredient Units mg/mL
    Substance Name LACOSAMIDE
    Labeler Name Leading Pharma, LLC
    Pharmaceutical Class Decreased Central Nervous System Disorganized Electrical Activity [PE]
    DEA Schedule CV
    Marketing Category ANDA
    Application Number ANDA216461
    Listing Certified Through 2024-12-31

    Package

    NDC 69315-0318-20 (69315031820)

    NDC Package Code 69315-318-20
    Billing NDC 69315031820
    Package 200 mL in 1 BOTTLE, PLASTIC (69315-318-20)
    Marketing Start Date 2023-07-25
    NDC Exclude Flag N
    Pricing Information N/A