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    NDC 70000-0117-01 Leader Nicotine 2 mg/1 Details

    Leader Nicotine 2 mg/1

    Leader Nicotine is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. The primary component is NICOTINE.

    Product Information

    NDC 70000-0117
    Product ID 70000-0117_24ab5894-ad52-453b-a3ed-263cb6af5bf5
    Associated GPIs 62100010004710
    GCN Sequence Number 077141
    GCN Sequence Number Description nicotine polacrilex LOZNG MINI 2 MG BUCCAL
    HIC3 J3A
    HIC3 Description SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS)
    GCN 43057
    HICL Sequence Number 002049
    HICL Sequence Number Description NICOTINE POLACRILEX
    Brand/Generic Generic
    Proprietary Name Leader Nicotine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Nicotine Polacrilex
    Product Type HUMAN OTC DRUG
    Dosage Form LOZENGE
    Route ORAL
    Active Ingredient Strength 2
    Active Ingredient Units mg/1
    Substance Name NICOTINE
    Labeler Name Cardinal Health 110, LLC. dba Leader
    Pharmaceutical Class Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203690
    Listing Certified Through 2024-12-31

    Package

    NDC 70000-0117-01 (70000011701)

    NDC Package Code 70000-0117-1
    Billing NDC 70000011701
    Package 3 CONTAINER in 1 CARTON (70000-0117-1) / 27 LOZENGE in 1 CONTAINER
    Marketing Start Date 2016-09-20
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 49871743-6a6d-4f76-972d-a272baaeae65 Details

    Revised: 6/2021