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    NDC 63629-3405-04 zaleplon 10 mg/1 Details

    zaleplon 10 mg/1

    zaleplon is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is ZALEPLON.

    Product Information

    NDC 63629-3405
    Product ID 63629-3405_b59bfb24-a009-4400-9ba3-c3d8fd08b36a
    Associated GPIs 60204070000130
    GCN Sequence Number 042994
    GCN Sequence Number Description zaleplon CAPSULE 10 MG ORAL
    HIC3 H2E
    HIC3 Description SEDATIVE-HYPNOTICS,NON-BARBITURATE
    GCN 92723
    HICL Sequence Number 020347
    HICL Sequence Number Description ZALEPLON
    Brand/Generic Generic
    Proprietary Name zaleplon
    Proprietary Name Suffix n/a
    Non-Proprietary Name zaleplon
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/1
    Substance Name ZALEPLON
    Labeler Name Bryant Ranch Prepack
    Pharmaceutical Class Central Nervous System Depression [PE], GABA A Agonists [MoA], gamma-Aminobutyric Acid A Receptor Agonist [EPC]
    DEA Schedule CIV
    Marketing Category ANDA
    Application Number ANDA078989
    Listing Certified Through 2024-12-31

    Package

    NDC 63629-3405-04 (63629340504)

    NDC Package Code 63629-3405-4
    Billing NDC 63629340504
    Package 90 CAPSULE in 1 BOTTLE (63629-3405-4)
    Marketing Start Date 2013-05-31
    NDC Exclude Flag N
    Pricing Information N/A