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    NDC 69339-0150-19 Guaifenesin Syrup and Dextromethorphan 10; 100 mg/5mL; mg/5mL Details

    Guaifenesin Syrup and Dextromethorphan 10; 100 mg/5mL; mg/5mL

    Guaifenesin Syrup and Dextromethorphan is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by Natco Pharma USA LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.

    Product Information

    NDC 69339-0150
    Product ID 69339-150_6bc4ec89-dcf0-4e03-ac41-abb85c1a5efd
    Associated GPIs 43997002521220
    GCN Sequence Number 016414
    GCN Sequence Number Description guaifenesin/dextromethorphan SYRUP 100-10MG/5 ORAL
    HIC3 B3T
    HIC3 Description NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION
    GCN 53495
    HICL Sequence Number 000223
    HICL Sequence Number Description GUAIFENESIN/DEXTROMETHORPHAN HBR
    Brand/Generic Generic
    Proprietary Name Guaifenesin Syrup and Dextromethorphan
    Proprietary Name Suffix n/a
    Non-Proprietary Name Guaifenesin Syrup and Dextromethorphan
    Product Type HUMAN OTC DRUG
    Dosage Form SYRUP
    Route ORAL
    Active Ingredient Strength 10; 100
    Active Ingredient Units mg/5mL; mg/5mL
    Substance Name DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
    Labeler Name Natco Pharma USA LLC
    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 69339-0150-19 (69339015019)

    NDC Package Code 69339-150-19
    Billing NDC 69339015019
    Package 10 TRAY in 1 CASE (69339-150-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-150-01)
    Marketing Start Date 2020-10-19
    NDC Exclude Flag N
    Pricing Information N/A