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    NDC 11822-4202-00 eye itch relief 0.35 mg/mL Details

    eye itch relief 0.35 mg/mL

    eye itch relief is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Rite Aid Corporation. The primary component is KETOTIFEN FUMARATE.

    Product Information

    NDC 11822-4202
    Product ID 11822-4202_99e27d97-9a66-46ec-a9cf-ffcc300ad7d0
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name eye itch relief
    Proprietary Name Suffix n/a
    Non-Proprietary Name ketotifen fumarate
    Product Type HUMAN OTC DRUG
    Dosage Form SOLUTION/ DROPS
    Route OPHTHALMIC
    Active Ingredient Strength 0.35
    Active Ingredient Units mg/mL
    Substance Name KETOTIFEN FUMARATE
    Labeler Name Rite Aid Corporation
    Pharmaceutical Class Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077958
    Listing Certified Through 2023-12-31

    Package

    NDC 11822-4202-00 (11822420200)

    NDC Package Code 11822-4202-0
    Billing NDC 11822420200
    Package 2 BOTTLE, DROPPER in 1 CARTON (11822-4202-0) / 5 mL in 1 BOTTLE, DROPPER
    Marketing Start Date 2013-12-06
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 6a077c02-1237-47f9-a762-757a0bedd992 Details

    Revised: 2/2022