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    NDC 50102-0300-13 Lyleq 0.35 mg/1 Details

    Lyleq 0.35 mg/1

    Lyleq is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Afaxys Pharma, LLC. The primary component is NORETHINDRONE.

    Product Information

    NDC 50102-0300
    Product ID 50102-300_ffb8f5fe-9e1a-4ca9-adc9-181093af01b9
    Associated GPIs 25100010000305
    GCN Sequence Number 003313
    GCN Sequence Number Description norethindrone TABLET 0.35 MG ORAL
    HIC3 G8A
    HIC3 Description CONTRACEPTIVES,ORAL
    GCN 11520
    HICL Sequence Number 001459
    HICL Sequence Number Description NORETHINDRONE
    Brand/Generic Generic
    Proprietary Name Lyleq
    Proprietary Name Suffix n/a
    Non-Proprietary Name NORETHINDRONE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 0.35
    Active Ingredient Units mg/1
    Substance Name NORETHINDRONE
    Labeler Name Afaxys Pharma, LLC
    Pharmaceutical Class Progesterone Congeners [CS], Progestin [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207304
    Listing Certified Through 2024-12-31

    Package

    NDC 50102-0300-13 (50102030013)

    NDC Package Code 50102-300-13
    Billing NDC 50102030013
    Package 3 PACKAGE in 1 CARTON (50102-300-13) / 1 BLISTER PACK in 1 PACKAGE (50102-300-11) / 28 TABLET in 1 BLISTER PACK (50102-300-01)
    Marketing Start Date 2016-09-23
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.11055
    Pricing Unit EA
    Effective Date 2024-02-21
    NDC Description LYLEQ 0.35 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