Search by Drug Name or NDC

    NDC 63629-8803-01 Estradiol 10 ug/1 Details

    Estradiol 10 ug/1

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

    Product Information

    NDC 63629-8803
    Product ID 63629-8803_77bfa766-1e62-4b42-807f-cd7c08a650d6
    Associated GPIs 55350020000310
    GCN Sequence Number 065966
    GCN Sequence Number Description estradiol TABLET 10 MCG VAGINAL
    HIC3 Q4K
    HIC3 Description VAGINAL ESTROGEN PREPARATIONS
    GCN 28107
    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 INSERT
    Route VAGINAL
    Active Ingredient Strength 10
    Active Ingredient Units ug/1
    Substance Name ESTRADIOL
    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 ANDA206388
    Listing Certified Through 2025-12-31

    Package

    NDC 63629-8803-01 (63629880301)

    NDC Package Code 63629-8803-1
    Billing NDC 63629880301
    Package 8 BLISTER PACK in 1 CARTON (63629-8803-1) / 1 APPLICATOR in 1 BLISTER PACK / 1 INSERT in 1 APPLICATOR
    Marketing Start Date 2021-09-10
    NDC Exclude Flag N
    Pricing Information N/A