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    NDC 36800-0863-78 Topcare Nicotine Gum 2 mg/1 Details

    Topcare Nicotine Gum 2 mg/1

    Topcare Nicotine Gum is a ORAL GUM, CHEWING in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is NICOTINE.

    Product Information

    NDC 36800-0863
    Product ID 36800-863_8943b9d7-4616-4cc1-8c25-7e8e194e9399
    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 Gum
    Proprietary Name Suffix n/a
    Non-Proprietary Name Nicotine polacrilex
    Product Type HUMAN OTC DRUG
    Dosage Form GUM, CHEWING
    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 ANDA206394
    Listing Certified Through 2024-12-31

    Package

    NDC 36800-0863-78 (36800086378)

    NDC Package Code 36800-863-78
    Billing NDC 36800086378
    Package 100 BLISTER PACK in 1 CARTON (36800-863-78) / 1 GUM, CHEWING in 1 BLISTER PACK
    Marketing Start Date 2017-02-13
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL f0f79275-c27a-4d35-a79a-53b0905c3761 Details

    Revised: 3/2021