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    NDC 36800-0967-78 topcare nicotine 4 mg/1 Details

    topcare nicotine 4 mg/1

    topcare nicotine 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 36800-0967
    Product ID 36800-967_15a281f4-f652-4729-9214-9d8a9eac4361
    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
    Proprietary Name Suffix n/a
    Non-Proprietary Name nicotine polacrilex
    Product Type HUMAN OTC DRUG
    Dosage Form GUM, CHEWING
    Route ORAL
    Active Ingredient Strength 4
    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 ANDA206393
    Listing Certified Through 2024-12-31

    Package

    NDC 36800-0967-78 (36800096778)

    NDC Package Code 36800-967-78
    Billing NDC 36800096778
    Package 100 BLISTER PACK in 1 CARTON (36800-967-78) / 1 GUM, CHEWING in 1 BLISTER PACK
    Marketing Start Date 2019-12-06
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 79d5ffe7-7fc1-4ab0-bce9-f6554b06dc0c Details

    Revised: 4/2021