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    NDC 42291-0426-42 Estradiol Vaginal 0.1 mg/g Details

    Estradiol Vaginal 0.1 mg/g

    Estradiol Vaginal is a VAGINAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is ESTRADIOL.

    Product Information

    NDC 42291-0426
    Product ID 42291-426_0e8fc3b1-2e7a-ac30-e063-6394a90ad8cb
    Associated GPIs 55350020003705
    GCN Sequence Number 007011
    GCN Sequence Number Description estradiol CREAM/APPL 0.01 % VAGINAL
    HIC3 Q4K
    HIC3 Description VAGINAL ESTROGEN PREPARATIONS
    GCN 67170
    HICL Sequence Number 001421
    HICL Sequence Number Description ESTRADIOL
    Brand/Generic Generic
    Proprietary Name Estradiol Vaginal
    Proprietary Name Suffix n/a
    Non-Proprietary Name Estradiol
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CREAM
    Route VAGINAL
    Active Ingredient Strength 0.1
    Active Ingredient Units mg/g
    Substance Name ESTRADIOL
    Labeler Name AvKARE
    Pharmaceutical Class Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA210194
    Listing Certified Through 2025-12-31

    Package

    NDC 42291-0426-42 (42291042642)

    NDC Package Code 42291-426-42
    Billing NDC 42291042642
    Package 1 TUBE in 1 CARTON (42291-426-42) / 42.5 g in 1 TUBE
    Marketing Start Date 2021-02-16
    NDC Exclude Flag N
    Pricing Information N/A