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    NDC 43386-0312-85 GAVILAX 17 g/17g Details

    GAVILAX 17 g/17g

    GAVILAX is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Lupin Pharmaceuticals,Inc.. The primary component is POLYETHYLENE GLYCOL 3350.

    Product Information

    NDC 43386-0312
    Product ID 43386-312_19242eae-03a4-4e7d-96e0-f942ed594a32
    Associated GPIs 46600033002910
    GCN Sequence Number 041843
    GCN Sequence Number Description polyethylene glycol 3350 POWDER 17 G/DOSE ORAL
    HIC3 D6S
    HIC3 Description LAXATIVES AND CATHARTICS
    GCN 86212
    HICL Sequence Number 022819
    HICL Sequence Number Description POLYETHYLENE GLYCOL 3350
    Brand/Generic Generic
    Proprietary Name GAVILAX
    Proprietary Name Suffix n/a
    Non-Proprietary Name Polyethylene Glycol 3350
    Product Type HUMAN OTC DRUG
    Dosage Form POWDER, FOR SOLUTION
    Route ORAL
    Active Ingredient Strength 17
    Active Ingredient Units g/17g
    Substance Name POLYETHYLENE GLYCOL 3350
    Labeler Name Lupin Pharmaceuticals,Inc.
    Pharmaceutical Class Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA091077
    Listing Certified Through 2024-12-31

    Package

    NDC 43386-0312-85 (43386031285)

    NDC Package Code 43386-312-85
    Billing NDC 43386031285
    Package 850 g in 1 BOTTLE (43386-312-85)
    Marketing Start Date 2009-10-09
    NDC Exclude Flag N
    Pricing Information N/A