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    NDC 42291-0929-53 Varenicline Details

    Varenicline

    Varenicline is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is .

    Product Information

    NDC 42291-0929
    Product ID 42291-929_0552b8e6-579f-60f5-e063-6394a90ad1bf
    Associated GPIs
    GCN Sequence Number 060898
    GCN Sequence Number Description varenicline tartrate TAB DS PK 0.5 (11)-1 ORAL
    HIC3 J3C
    HIC3 Description SMOKING DETERRENT-NICOTINIC RECEPT.PARTIAL AGONIST
    GCN 27048
    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 tartrate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form KIT
    Route n/a
    Active Ingredient Strength n/a
    Active Ingredient Units n/a
    Substance Name n/a
    Labeler Name AvKARE
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA214557
    Listing Certified Through 2024-12-31

    Package

    NDC 42291-0929-53 (42291092953)

    NDC Package Code 42291-929-53
    Billing NDC 42291092953
    Package 1 KIT in 1 CARTON (42291-929-53) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
    Marketing Start Date 2023-09-14
    NDC Exclude Flag N
    Pricing Information N/A