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    NDC 43393-0001-06 Mifepristone 200 mg/1 Details

    Mifepristone 200 mg/1

    Mifepristone is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by GenBioPro, Inc.. The primary component is MIFEPRISTONE.

    Product Information

    NDC 43393-0001
    Product ID 43393-001_f827a5f5-c021-61dd-e053-6294a90a94d9
    Associated GPIs 30502060000320
    GCN Sequence Number 046706
    GCN Sequence Number Description mifepristone TABLET 200 MG ORAL
    HIC3 G8D
    HIC3 Description ABORTIFACIENT-PROGESTERONE RECEPTOR ANTAGONISTS
    GCN 12207
    HICL Sequence Number 007325
    HICL Sequence Number Description MIFEPRISTONE
    Brand/Generic Generic
    Proprietary Name Mifepristone
    Proprietary Name Suffix n/a
    Non-Proprietary Name MIFEPRISTONE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 200
    Active Ingredient Units mg/1
    Substance Name MIFEPRISTONE
    Labeler Name GenBioPro, Inc.
    Pharmaceutical Class Progestational Hormone Receptor Antagonists [MoA], Progestin Antagonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA091178
    Listing Certified Through 2024-12-31

    Package

    NDC 43393-0001-06 (43393000106)

    NDC Package Code 43393-001-06
    Billing NDC 43393000106
    Package 6 CARTON in 1 PACKAGE (43393-001-06) / 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (43393-001-01)
    Marketing Start Date 2019-05-01
    NDC Exclude Flag N
    Pricing Information N/A