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    NDC 43063-0505-30 ZALEPLON 5 mg/1 Details

    ZALEPLON 5 mg/1

    ZALEPLON is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. The primary component is ZALEPLON.

    Product Information

    NDC 43063-0505
    Product ID 43063-505_0646fb64-bd11-589e-e063-6394a90a0199
    Associated GPIs 60204070000120
    GCN Sequence Number 042993
    GCN Sequence Number Description zaleplon CAPSULE 5 MG ORAL
    HIC3 H2E
    HIC3 Description SEDATIVE-HYPNOTICS,NON-BARBITURATE
    GCN 92713
    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 5
    Active Ingredient Units mg/1
    Substance Name ZALEPLON
    Labeler Name PD-Rx Pharmaceuticals, Inc.
    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 ANDA078829
    Listing Certified Through 2024-12-31

    Package

    NDC 43063-0505-30 (43063050530)

    NDC Package Code 43063-505-30
    Billing NDC 43063050530
    Package 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-505-30)
    Marketing Start Date 2013-05-17
    NDC Exclude Flag N
    Pricing Information N/A