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    NDC 00121-0577-08 LACTULOSE 10 g/15mL Details

    LACTULOSE 10 g/15mL

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

    Product Information

    NDC 00121-0577
    Product ID 0121-0577_fb1e9286-2489-4141-87b8-1039e49f0d83
    Associated GPIs 46600020002010
    GCN Sequence Number 029054
    GCN Sequence Number Description lactulose SOLUTION 10 G/15 ML ORAL
    HIC3 D6S
    HIC3 Description LAXATIVES AND CATHARTICS
    GCN 10167
    HICL Sequence Number 001396
    HICL Sequence Number Description LACTULOSE
    Brand/Generic Generic
    Proprietary Name LACTULOSE
    Proprietary Name Suffix n/a
    Non-Proprietary Name LACTULOSE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units g/15mL
    Substance Name LACTULOSE
    Labeler Name PAI Holdings, LLC
    Pharmaceutical Class Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA074623
    Listing Certified Through 2024-12-31

    Package

    NDC 00121-0577-08 (00121057708)

    NDC Package Code 0121-0577-08
    Billing NDC 00121057708
    Package 237 mL in 1 BOTTLE (0121-0577-08)
    Marketing Start Date 1966-07-30
    NDC Exclude Flag N
    Pricing Information N/A