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    NDC 00363-0919-78 Nicotine 4 mg/1 Details

    Nicotine 4 mg/1

    Nicotine is a ORAL GUM, CHEWING in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is NICOTINE.

    Product Information

    NDC 00363-0919
    Product ID 0363-0919_e49e88a5-07f5-4c8f-b630-1ace1da11b84
    Associated GPIs
    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 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 Walgreen Company
    Pharmaceutical Class Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA076779
    Listing Certified Through 2024-12-31

    Package

    NDC 00363-0919-78 (00363091978)

    NDC Package Code 0363-0919-78
    Billing NDC 00363091978
    Package 100 BLISTER PACK in 1 CARTON (0363-0919-78) / 1 GUM, CHEWING in 1 BLISTER PACK
    Marketing Start Date 2014-03-18
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL c44821ba-5c2a-4586-8210-afc02a4031d5 Details

    Revised: 9/2022