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    NDC 63629-8713-01 Estradiol 0.1 mg/g Details

    Estradiol 0.1 mg/g

    Estradiol is a VAGINAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is ESTRADIOL HEMIHYDRATE.

    Product Information

    NDC 63629-8713
    Product ID 63629-8713_ad4ed7c0-a2a3-41cc-b380-57616f5bf6f7
    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
    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 HEMIHYDRATE
    Labeler Name Bryant Ranch Prepack
    Pharmaceutical Class Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA209767
    Listing Certified Through 2024-12-31

    Package

    NDC 63629-8713-01 (63629871301)

    NDC Package Code 63629-8713-1
    Billing NDC 63629871301
    Package 1 TUBE, WITH APPLICATOR in 1 CARTON (63629-8713-1) / 42.5 g in 1 TUBE, WITH APPLICATOR
    Marketing Start Date 2021-08-19
    NDC Exclude Flag N
    Pricing Information N/A