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    NDC 70710-1641-01 Lubiprostone 8 ug/1 Details

    Lubiprostone 8 ug/1

    Lubiprostone is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is LUBIPROSTONE.

    Product Information

    NDC 70710-1641
    Product ID 70710-1641_f06e99fa-9894-48ab-99d8-914987dbb73f
    Associated GPIs
    GCN Sequence Number 063946
    GCN Sequence Number Description lubiprostone CAPSULE 8 MCG ORAL
    HIC3 D6S
    HIC3 Description LAXATIVES AND CATHARTICS
    GCN 99658
    HICL Sequence Number 033451
    HICL Sequence Number Description LUBIPROSTONE
    Brand/Generic Generic
    Proprietary Name Lubiprostone
    Proprietary Name Suffix n/a
    Non-Proprietary Name Lubiprostone
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 8
    Active Ingredient Units ug/1
    Substance Name LUBIPROSTONE
    Labeler Name Zydus Pharmaceuticals USA Inc.
    Pharmaceutical Class Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA214131
    Listing Certified Through 2024-12-31

    Package

    NDC 70710-1641-01 (70710164101)

    NDC Package Code 70710-1641-1
    Billing NDC 70710164101
    Package 100 CAPSULE in 1 BOTTLE (70710-1641-1)
    Marketing Start Date 2023-03-23
    NDC Exclude Flag N
    Pricing Information N/A