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    NDC 47335-0317-90 XELPROS 0.05 mg/mL Details

    XELPROS 0.05 mg/mL

    XELPROS is a OPHTHALMIC; TOPICAL SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is LATANOPROST.

    Product Information

    NDC 47335-0317
    Product ID 47335-317_c866d64c-e5c1-4ae5-b023-957d0211581d
    Associated GPIs 86330050001620
    GCN Sequence Number 078927
    GCN Sequence Number Description latanoprost DRPS EMULS 0.005 % OPHTHALMIC
    HIC3 Q6G
    HIC3 Description MIOTICS AND OTHER INTRAOCULAR PRESSURE REDUCERS
    GCN 45371
    HICL Sequence Number 011560
    HICL Sequence Number Description LATANOPROST
    Brand/Generic Brand
    Proprietary Name XELPROS
    Proprietary Name Suffix n/a
    Non-Proprietary Name latanoprost
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION/ DROPS
    Route OPHTHALMIC; TOPICAL
    Active Ingredient Strength 0.05
    Active Ingredient Units mg/mL
    Substance Name LATANOPROST
    Labeler Name Sun Pharmaceutical Industries, Inc.
    Pharmaceutical Class Prostaglandin Analog [EPC], Prostaglandins [CS]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA206185
    Listing Certified Through 2024-12-31

    Package

    NDC 47335-0317-90 (47335031790)

    NDC Package Code 47335-317-90
    Billing NDC 47335031790
    Package 1 BOTTLE, DROPPER in 1 BOX (47335-317-90) / 2.5 mL in 1 BOTTLE, DROPPER
    Marketing Start Date 2018-09-12
    NDC Exclude Flag N
    Pricing Information N/A