Search by Drug Name or NDC

    NDC 60505-3613-05 VARENICLINE 0.5 mg/1 Details

    VARENICLINE 0.5 mg/1

    VARENICLINE is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Apotex Corp. The primary component is VARENICLINE TARTRATE.

    Product Information

    NDC 60505-3613
    Product ID 60505-3613_b320350d-ea25-000d-b064-9316b177edca
    Associated GPIs
    GCN Sequence Number 060896
    GCN Sequence Number Description varenicline tartrate TABLET 0.5 MG ORAL
    HIC3 J3C
    HIC3 Description SMOKING DETERRENT-NICOTINIC RECEPT.PARTIAL AGONIST
    GCN 27046
    HICL Sequence Number 033766
    HICL Sequence Number Description VARENICLINE TARTRATE
    Brand/Generic Generic
    Proprietary Name VARENICLINE
    Proprietary Name Suffix n/a
    Non-Proprietary Name VARENICLINE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 0.5
    Active Ingredient Units mg/1
    Substance Name VARENICLINE TARTRATE
    Labeler Name Apotex Corp
    Pharmaceutical Class Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA201962
    Listing Certified Through 2024-12-31

    Package

    NDC 60505-3613-05 (60505361305)

    NDC Package Code 60505-3613-5
    Billing NDC 60505361305
    Package 56 TABLET, FILM COATED in 1 BOTTLE (60505-3613-5)
    Marketing Start Date 2023-01-26
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 2.43871
    Pricing Unit EA
    Effective Date 2024-02-21
    NDC Description VARENICLINE 0.5 MG TABLET
    Pharmacy Type Indicator C/I
    OTC N
    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