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    NDC 00135-0158-11 Nicorette 4 mg/1 Details

    Nicorette 4 mg/1

    Nicorette is a ORAL GUM, CHEWING in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is NICOTINE.

    Product Information

    NDC 00135-0158
    Product ID 0135-0158_76540e6a-4694-4b85-b461-ed57698a5d41
    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 Brand
    Proprietary Name Nicorette
    Proprietary Name Suffix Original
    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 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
    Pharmaceutical Class Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA020066
    Listing Certified Through 2024-12-31

    Package

    NDC 00135-0158-11 (00135015811)

    NDC Package Code 0135-0158-11
    Billing NDC 00135015811
    Package 1 BLISTER PACK in 1 CARTON (0135-0158-11) / 200 GUM, CHEWING in 1 BLISTER PACK
    Marketing Start Date 2009-06-29
    NDC Exclude Flag N
    Pricing Information N/A