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    NDC 45737-0225-16 BioTPres 15; 200; 5 mg/5mL; mg/5mL; mg/5mL Details

    BioTPres 15; 200; 5 mg/5mL; mg/5mL; mg/5mL

    BioTPres 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; PHENYLEPHRINE HYDROCHLORIDE.

    Product Information

    NDC 45737-0225
    Product ID 45737-225_7ae95891-2078-4569-bbcf-c96fadc2fc6f
    Associated GPIs 43997303100970
    GCN Sequence Number 065638
    GCN Sequence Number Description guaifen/dextromethorphan/PE LIQUID 200-10-5/5 ORAL
    HIC3 B4R
    HIC3 Description NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT
    GCN 27655
    HICL Sequence Number 000216
    HICL Sequence Number Description GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE
    Brand/Generic Brand
    Proprietary Name BioTPres
    Proprietary Name Suffix n/a
    Non-Proprietary Name Dextromethorphan, Guaifenesin, Phenylephrine
    Product Type HUMAN OTC DRUG
    Dosage Form LIQUID
    Route ORAL
    Active Ingredient Strength 15; 200; 5
    Active Ingredient Units mg/5mL; mg/5mL; mg/5mL
    Substance Name DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
    Labeler Name Advanced Generic Corporation
    Pharmaceutical Class Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part341
    Listing Certified Through 2022-12-31

    Package

    NDC 45737-0225-16 (45737022516)

    NDC Package Code 45737-225-16
    Billing NDC 45737022516
    Package 473 mL in 1 BOTTLE (45737-225-16)
    Marketing Start Date 2009-10-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 42eb824f-4de4-4c67-9932-6038a8dbea8c Details

    Revised: 12/2020