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    NDC 36800-0375-05 topcare nicotine polacrilex 2 mg/1 Details

    topcare nicotine polacrilex 2 mg/1

    topcare nicotine polacrilex is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is NICOTINE.

    Product Information

    NDC 36800-0375
    Product ID 36800-375_9e612581-f787-4fd1-8642-1b5b55f6e178
    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 nicotine polacrilex
    Proprietary Name Suffix n/a
    Non-Proprietary Name Nicotine Polacrilex
    Product Type HUMAN OTC DRUG
    Dosage Form LOZENGE
    Route ORAL
    Active Ingredient Strength 2
    Active Ingredient Units mg/1
    Substance Name NICOTINE
    Labeler Name Topco Associates LLC
    Pharmaceutical Class Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA090711
    Listing Certified Through 2024-12-31

    Package

    NDC 36800-0375-05 (36800037505)

    NDC Package Code 36800-375-05
    Billing NDC 36800037505
    Package 3 CONTAINER in 1 CARTON (36800-375-05) / 24 LOZENGE in 1 CONTAINER
    Marketing Start Date 2013-02-13
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL d0403746-f866-42da-ad66-2a686c8bce01 Details

    Revised: 11/2018