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    NDC 36800-0494-21 TopCare Cough DM 30 mg/5mL Details

    TopCare Cough DM 30 mg/5mL

    TopCare Cough DM is a ORAL SUSPENSION, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE.

    Product Information

    NDC 36800-0494
    Product ID 36800-494_d8b67767-4748-4233-b41e-7d676d4730e5
    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 TopCare Cough DM
    Proprietary Name Suffix n/a
    Non-Proprietary Name dextromethorphan polistirex
    Product Type HUMAN OTC DRUG
    Dosage Form SUSPENSION, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 30
    Active Ingredient Units mg/5mL
    Substance Name DEXTROMETHORPHAN HYDROBROMIDE
    Labeler Name Topco Associates LLC
    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 ANDA
    Application Number ANDA091135
    Listing Certified Through 2024-12-31

    Package

    NDC 36800-0494-21 (36800049421)

    NDC Package Code 36800-494-21
    Billing NDC 36800049421
    Package 1 BOTTLE in 1 CARTON (36800-494-21) / 89 mL in 1 BOTTLE
    Marketing Start Date 2015-07-30
    NDC Exclude Flag N
    Pricing Information N/A