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    NDC 36800-0650-60 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 36800-0650
    Product ID 36800-650_c5f7a858-8f41-4ea5-8354-aa9098741447
    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 36800-0650-60 (36800065060)

    NDC Package Code 36800-650-60
    Billing NDC 36800065060
    Package 20 BLISTER PACK in 1 CARTON (36800-650-60) / 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 03d9708a-923c-4fd3-ac3d-6ab4a4d8a804 Details

    Revised: 3/2021