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    NDC 43386-0700-02 SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE 1.6; 3.13; 17.5 g/177mL; g/177mL; g/177mL Details

    SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE 1.6; 3.13; 17.5 g/177mL; g/177mL; g/177mL

    SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE.

    Product Information

    NDC 43386-0700
    Product ID 43386-700_58ceb74b-a538-476d-a326-98ef0128a4c2
    Associated GPIs
    GCN Sequence Number 066670
    GCN Sequence Number Description sodium, potassium,mag sulfates SOLN RECON 17.5-3.13G ORAL
    HIC3 D6S
    HIC3 Description LAXATIVES AND CATHARTICS
    GCN 28997
    HICL Sequence Number 037152
    HICL Sequence Number Description SODIUM SULFATE/POTASSIUM SULFATE/MAGNESIUM SULFATE
    Brand/Generic Generic
    Proprietary Name SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE
    Proprietary Name Suffix n/a
    Non-Proprietary Name sodium sulfate, potassium sulfate, magnesium sulfate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 1.6; 3.13; 17.5
    Active Ingredient Units g/177mL; g/177mL; g/177mL
    Substance Name MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE
    Labeler Name Lupin Pharmaceuticals, Inc.
    Pharmaceutical Class Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Sma
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA202511
    Listing Certified Through 2024-12-31

    Package

    NDC 43386-0700-02 (43386070002)

    NDC Package Code 43386-700-02
    Billing NDC 43386070002
    Package 1 BOTTLE in 1 CONTAINER (43386-700-02) / 177 mL in 1 BOTTLE
    Marketing Start Date 2022-12-30
    NDC Exclude Flag N
    Pricing Information N/A