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    NDC 36800-0539-05 Topcare Nicotine 4 mg/1 Details

    Topcare Nicotine 4 mg/1

    Topcare Nicotine is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is NICOTINE.

    Product Information

    NDC 36800-0539
    Product ID 36800-539_f06bbce5-3e07-4dee-abbd-8e0a8306177d
    Associated GPIs 62100010004720
    GCN Sequence Number 048775
    GCN Sequence Number Description nicotine polacrilex LOZENGE 4 MG BUCCAL
    HIC3 J3A
    HIC3 Description SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS)
    GCN 14688
    HICL Sequence Number 002049
    HICL Sequence Number Description NICOTINE POLACRILEX
    Brand/Generic Generic
    Proprietary Name Topcare 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 Topco Associates LLC
    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 36800-0539-05 (36800053905)

    NDC Package Code 36800-539-05
    Billing NDC 36800053905
    Package 3 CONTAINER in 1 CARTON (36800-539-05) / 24 LOZENGE in 1 CONTAINER
    Marketing Start Date 2013-02-12
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 99da90fa-00ff-4c62-91a2-1e434dadaf41 Details

    Revised: 11/2018