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    NDC 80725-0010-30 Lunesta 1 mg/1 Details

    Lunesta 1 mg/1

    Lunesta is a ORAL TABLET, COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Waylis Therapeutics LLC. The primary component is ESZOPICLONE.

    Product Information

    NDC 80725-0010
    Product ID 80725-010_2c91f978-7c47-4f1d-8523-417d038c5030
    Associated GPIs
    GCN Sequence Number 058484
    GCN Sequence Number Description eszopiclone TABLET 1 MG ORAL
    HIC3 H2E
    HIC3 Description SEDATIVE-HYPNOTICS,NON-BARBITURATE
    GCN 23927
    HICL Sequence Number 026791
    HICL Sequence Number Description ESZOPICLONE
    Brand/Generic Brand
    Proprietary Name Lunesta
    Proprietary Name Suffix n/a
    Non-Proprietary Name ESZOPICLONE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, COATED
    Route ORAL
    Active Ingredient Strength 1
    Active Ingredient Units mg/1
    Substance Name ESZOPICLONE
    Labeler Name Waylis Therapeutics LLC
    Pharmaceutical Class n/a
    DEA Schedule CIV
    Marketing Category NDA
    Application Number NDA021476
    Listing Certified Through 2024-12-31

    Package

    NDC 80725-0010-30 (80725001030)

    NDC Package Code 80725-010-30
    Billing NDC 80725001030
    Package 30 TABLET, COATED in 1 BOTTLE (80725-010-30)
    Marketing Start Date 2023-08-15
    NDC Exclude Flag N
    Pricing Information N/A