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    NDC 58602-0723-85 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 Aurohealth LLC. The primary component is NICOTINE.

    Product Information

    NDC 58602-0723
    Product ID 58602-723_85f05cc6-ae2e-4338-8c1e-c681c2f90858
    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 POLACRILEX MINI
    Product Type HUMAN OTC DRUG
    Dosage Form LOZENGE
    Route ORAL
    Active Ingredient Strength 4
    Active Ingredient Units mg/1
    Substance Name NICOTINE
    Labeler Name Aurohealth LLC
    Pharmaceutical Class Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA215357
    Listing Certified Through 2024-12-31

    Package

    NDC 58602-0723-85 (58602072385)

    NDC Package Code 58602-723-85
    Billing NDC 58602072385
    Package 5 CONTAINER in 1 CARTON (58602-723-85) / 27 LOZENGE in 1 CONTAINER
    Marketing Start Date 2022-11-03
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 85f05cc6-ae2e-4338-8c1e-c681c2f90858 Details

    Revised: 11/2022