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    NDC 00363-0365-78 Nicotine 2 mg/1 Details

    Nicotine 2 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 00363-0365
    Product ID 0363-0365_3f364d1d-07d0-4b85-bda1-bc5edcac2652
    Associated GPIs 62100010002810
    GCN Sequence Number 004930
    GCN Sequence Number Description nicotine polacrilex GUM 2 MG BUCCAL
    HIC3 J3A
    HIC3 Description SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS)
    GCN 03200
    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 2
    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 ANDA091349
    Listing Certified Through 2024-12-31

    Package

    NDC 00363-0365-78 (00363036578)

    NDC Package Code 0363-0365-78
    Billing NDC 00363036578
    Package 100 BLISTER PACK in 1 CARTON (0363-0365-78) / 1 GUM, CHEWING in 1 BLISTER PACK
    Marketing Start Date 2013-06-07
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 9adf55d6-330b-4828-bab3-befad8c950ef Details

    Revised: 10/2022