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    NDC 58552-0134-04 Giltuss Diabetic 20; 200 mg/10mL; mg/10mL Details

    Giltuss Diabetic 20; 200 mg/10mL; mg/10mL

    Giltuss Diabetic is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Gil Pharmaceutical Corp. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.

    Product Information

    NDC 58552-0134
    Product ID 58552-134_08754bfc-ff96-e11e-e063-6394a90a6540
    Associated GPIs 43997002520910
    GCN Sequence Number 000652
    GCN Sequence Number Description guaifenesin/dextromethorphan LIQUID 100-10MG/5 ORAL
    HIC3 B3T
    HIC3 Description NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION
    GCN 53491
    HICL Sequence Number 000223
    HICL Sequence Number Description GUAIFENESIN/DEXTROMETHORPHAN HBR
    Brand/Generic Generic
    Proprietary Name Giltuss Diabetic
    Proprietary Name Suffix Cough and Cold
    Non-Proprietary Name Dextromethorphan hydrobromide, Guaifenesin
    Product Type HUMAN OTC DRUG
    Dosage Form SOLUTION
    Route ORAL
    Active Ingredient Strength 20; 200
    Active Ingredient Units mg/10mL; mg/10mL
    Substance Name DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
    Labeler Name Gil Pharmaceutical Corp
    Pharmaceutical Class Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Ant
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH DRUG
    Application Number M012
    Listing Certified Through 2024-12-31

    Package

    NDC 58552-0134-04 (58552013404)

    NDC Package Code 58552-134-04
    Billing NDC 58552013404
    Package 1 BOTTLE in 1 CARTON (58552-134-04) / 118 mL in 1 BOTTLE
    Marketing Start Date 2018-10-17
    NDC Exclude Flag N
    Pricing Information N/A