Search by Drug Name or NDC

    NDC 70000-0121-00 Leader Nicotine 4 mg/1 Details

    Leader Nicotine 4 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 70000-0121
    Product ID 70000-0121_3164ba9f-09a7-4805-8d4c-9e3dad2aae38
    Associated GPIs 62100010004720
    GCN Sequence Number 077140
    GCN Sequence Number Description nicotine polacrilex LOZNG MINI 4 MG BUCCAL
    HIC3 J3A
    HIC3 Description SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS)
    GCN 43056
    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 4
    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 70000-0121-00 (70000012100)

    NDC Package Code 70000-0121-0
    Billing NDC 70000012100
    Package 3 CONTAINER in 1 CARTON (70000-0121-0) / 27 LOZENGE in 1 CONTAINER
    Marketing Start Date 2016-09-27
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.38843
    Pricing Unit EA
    Effective Date 2022-01-19
    NDC Description NICOTINE 4 MG MINI LOZENGE
    Pharmacy Type Indicator C/I
    OTC Y
    Explanation Code 4
    Classification for Rate Setting G
    As of Date 2022-03-16
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

    Standard Product Labeling (SPL)/Prescribing Information SPL f028c625-aa4c-4458-86df-373b9808e23e Details

    Revised: 6/2021