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    NDC 45802-0089-02 Nicotine Polacrilex 2 mg/1 Details

    Nicotine Polacrilex 2 mg/1

    Nicotine Polacrilex is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is NICOTINE.

    Product Information

    NDC 45802-0089
    Product ID 45802-089_365ced3c-1cba-43a1-9b6e-346532d5bfa6
    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 Nicotine Polacrilex
    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 Padagis Israel Pharmaceuticals Ltd
    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 45802-0089-02 (45802008902)

    NDC Package Code 45802-089-02
    Billing NDC 45802008902
    Package 3 CONTAINER in 1 CARTON (45802-089-02) / 27 LOZENGE in 1 CONTAINER
    Marketing Start Date 2016-07-08
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.3805
    Pricing Unit EA
    Effective Date 2024-02-21
    NDC Description NICOTINE 2 MG MINI LOZENGE
    Pharmacy Type Indicator C/I
    OTC Y
    Explanation Code 1
    Classification for Rate Setting G
    As of Date 2024-02-21
    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 b765570e-e5b5-48e4-b4d2-2a85ac19a2ea Details

    Revised: 11/2021