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    NDC 45737-0264-16 Biospec 10; 187 mg/5mL; mg/5mL Details

    Biospec 10; 187 mg/5mL; mg/5mL

    Biospec is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Advanced Generic Corporation. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.

    Product Information

    NDC 45737-0264
    Product ID 45737-264_2a2354c5-aee5-4dc9-b397-3d10c72a9b58
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Biospec
    Proprietary Name Suffix DMX
    Non-Proprietary Name Dextromethorphan, Guaifenesin
    Product Type HUMAN OTC DRUG
    Dosage Form LIQUID
    Route ORAL
    Active Ingredient Strength 10; 187
    Active Ingredient Units mg/5mL; mg/5mL
    Substance Name DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
    Labeler Name Advanced Generic Corporation
    Pharmaceutical Class Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part341
    Listing Certified Through 2024-12-31

    Package

    NDC 45737-0264-16 (45737026416)

    NDC Package Code 45737-264-16
    Billing NDC 45737026416
    Package 473 mL in 1 BOTTLE (45737-264-16)
    Marketing Start Date 2015-03-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL eb29e7cc-e6bb-4b33-88ee-aa3acd6f2970 Details

    Revised: 12/2020