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    NDC 00023-5301-08 Restasis MultiDose 0.5 mg/mL Details

    Restasis MultiDose 0.5 mg/mL

    Restasis MultiDose is a OPHTHALMIC EMULSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Allergan, Inc.. The primary component is CYCLOSPORINE.

    Product Information

    NDC 00023-5301
    Product ID 0023-5301_884a1d8c-14e0-464c-a6b6-bfdd7009d514
    Associated GPIs 86720020001620
    GCN Sequence Number 076793
    GCN Sequence Number Description cyclosporine DROPS 0.05 % OPHTHALMIC
    HIC3 Q2C
    HIC3 Description OPHTHALMIC ANTI-INFLAMMATORY IMMUNOMODULATOR-TYPE
    GCN 42588
    HICL Sequence Number 004524
    HICL Sequence Number Description CYCLOSPORINE
    Brand/Generic Brand
    Proprietary Name Restasis MultiDose
    Proprietary Name Suffix n/a
    Non-Proprietary Name cyclosporine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form EMULSION
    Route OPHTHALMIC
    Active Ingredient Strength 0.5
    Active Ingredient Units mg/mL
    Substance Name CYCLOSPORINE
    Labeler Name Allergan, Inc.
    Pharmaceutical Class Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA050790
    Listing Certified Through 2024-12-31

    Package

    NDC 00023-5301-08 (00023530108)

    NDC Package Code 0023-5301-08
    Billing NDC 00023530108
    Package 1 BOTTLE in 1 CARTON (0023-5301-08) / 5.5 mL in 1 BOTTLE
    Marketing Start Date 2016-11-10
    NDC Exclude Flag N
    Pricing Information N/A