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    NDC 37808-0383-10 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 H E B. The primary component is NICOTINE.

    Product Information

    NDC 37808-0383
    Product ID 37808-383_fbecca27-2bc4-4673-ba65-b6fd6a446218
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name nicotine
    Proprietary Name Suffix n/a
    Non-Proprietary Name nicotine
    Product Type HUMAN OTC DRUG
    Dosage Form LOZENGE
    Route ORAL
    Active Ingredient Strength 4
    Active Ingredient Units mg/1
    Substance Name NICOTINE
    Labeler Name H E B
    Pharmaceutical Class Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA090711
    Listing Certified Through 2024-12-31

    Package

    NDC 37808-0383-10 (37808038310)

    NDC Package Code 37808-383-10
    Billing NDC 37808038310
    Package 4 CONTAINER in 1 CARTON (37808-383-10) / 27 LOZENGE in 1 CONTAINER
    Marketing Start Date 2019-04-17
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 98633912-74d8-49db-a03e-4a3f882297ac Details

    Revised: 4/2019