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    NDC 36800-0957-02 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 36800-0957
    Product ID 36800-957_bd043d8b-19d9-409b-9def-03befd19604d
    Associated GPIs 62100010004720
    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 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 ANDA203690
    Listing Certified Through 2024-12-31

    Package

    NDC 36800-0957-02 (36800095702)

    NDC Package Code 36800-957-02
    Billing NDC 36800095702
    Package 3 CONTAINER in 1 CARTON (36800-957-02) / 27 LOZENGE in 1 CONTAINER
    Marketing Start Date 2013-02-14
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 9f2f06c3-4d9b-4c1a-85e3-26f021be5d7c Details

    Revised: 5/2021