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    NDC 00363-0424-05 Nicotine 4 mg/1 Details

    Nicotine 4 mg/1

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

    Product Information

    NDC 00363-0424
    Product ID 0363-0424_25ffadb3-a5e9-41a8-b788-97604f6b65d5
    Associated GPIs 62100010004720
    GCN Sequence Number 048775
    GCN Sequence Number Description nicotine polacrilex LOZENGE 4 MG BUCCAL
    HIC3 J3A
    HIC3 Description SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS)
    GCN 14688
    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 LOZENGE
    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 ANDA090821
    Listing Certified Through 2024-12-31

    Package

    NDC 00363-0424-05 (00363042405)

    NDC Package Code 0363-0424-05
    Billing NDC 00363042405
    Package 3 CONTAINER in 1 CARTON (0363-0424-05) / 24 LOZENGE in 1 CONTAINER
    Marketing Start Date 2010-01-12
    NDC Exclude Flag N
    Pricing Information N/A