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    NDC 36800-0170-60 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 36800-0170
    Product ID 36800-170_0ef9405d-d300-45f0-a1bb-f358dfd9245d
    Associated GPIs 62100010002820
    GCN Sequence Number 013486
    GCN Sequence Number Description nicotine polacrilex GUM 4 MG BUCCAL
    HIC3 J3A
    HIC3 Description SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS)
    GCN 03201
    HICL Sequence Number 002049
    HICL Sequence Number Description NICOTINE POLACRILEX
    Brand/Generic Generic
    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 ANDA076789
    Listing Certified Through 2024-12-31

    Package

    NDC 36800-0170-60 (36800017060)

    NDC Package Code 36800-170-60
    Billing NDC 36800017060
    Package 20 BLISTER PACK in 1 CARTON (36800-170-60) / 1 GUM, CHEWING in 1 BLISTER PACK
    Marketing Start Date 2013-02-14
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 1a916693-6092-4875-872a-7438816c0ddf Details

    Revised: 11/2021