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    NDC 42291-0478-03 Etonogestrel and Ethinyl Estradiol Vaginal .015; .12 mg/d; mg/d Details

    Etonogestrel and Ethinyl Estradiol Vaginal .015; .12 mg/d; mg/d

    Etonogestrel and Ethinyl Estradiol Vaginal is a VAGINAL RING in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is ETHINYL ESTRADIOL; ETONOGESTREL.

    Product Information

    NDC 42291-0478
    Product ID 42291-478_05e172aa-e18b-427b-e063-6294a90ae22f
    Associated GPIs
    GCN Sequence Number 050464
    GCN Sequence Number Description etonogestrel/ethinyl estradiol VAG RING .12-.015MG VAGINAL
    HIC3 G9B
    HIC3 Description CONTRACEPTIVES, INTRAVAGINAL, SYSTEMIC
    GCN 17528
    HICL Sequence Number 023721
    HICL Sequence Number Description ETONOGESTREL/ETHINYL ESTRADIOL
    Brand/Generic Generic
    Proprietary Name Etonogestrel and Ethinyl Estradiol Vaginal
    Proprietary Name Suffix n/a
    Non-Proprietary Name Etonogestrel and Ethinyl Estradiol Vaginal
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form RING
    Route VAGINAL
    Active Ingredient Strength .015; .12
    Active Ingredient Units mg/d; mg/d
    Substance Name ETHINYL ESTRADIOL; ETONOGESTREL
    Labeler Name AvKARE
    Pharmaceutical Class Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA211157
    Listing Certified Through 2024-12-31

    Package

    NDC 42291-0478-03 (42291047803)

    NDC Package Code 42291-478-03
    Billing NDC 42291047803
    Package 3 POUCH in 1 CARTON (42291-478-03) / 21 d in 1 POUCH (42291-478-11)
    Marketing Start Date 2023-09-21
    NDC Exclude Flag N
    Pricing Information N/A