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    NDC 72189-0212-05 KETOTIFEN FUMARATE 0.35 mg/mL Details

    KETOTIFEN FUMARATE 0.35 mg/mL

    KETOTIFEN FUMARATE is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by DIRECT RX. The primary component is KETOTIFEN FUMARATE.

    Product Information

    NDC 72189-0212
    Product ID 72189-212_c2d7d12d-4186-6bde-e053-2995a90a538e
    Associated GPIs 86802040102010
    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 KETOTIFEN FUMARATE
    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 DIRECT RX
    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 72189-0212-05 (72189021205)

    NDC Package Code 72189-212-05
    Billing NDC 72189021205
    Package 5 mL in 1 BOTTLE (72189-212-05)
    Marketing Start Date 2021-05-07
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL a8ee2e96-d09a-d0fe-e053-2a95a90a30b1 Details

    Revised: 5/2021