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    NDC 70069-0051-12 DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Details

    DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE 20; 5 mg/mL; mg/mL

    DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE is a OPHTHALMIC SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Somerset Therapeutics, LLC. The primary component is DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE.

    Product Information

    NDC 70069-0051
    Product ID 70069-051_3acff60b-3a7a-4b15-8d13-950b9cd77f81
    Associated GPIs 86259902202020
    GCN Sequence Number 039531
    GCN Sequence Number Description dorzolamide HCl/timolol maleat DROPS 22.3-6.8/1 OPHTHALMIC
    HIC3 Q6G
    HIC3 Description MIOTICS AND OTHER INTRAOCULAR PRESSURE REDUCERS
    GCN 95919
    HICL Sequence Number 018269
    HICL Sequence Number Description DORZOLAMIDE HCL/TIMOLOL MALEATE
    Brand/Generic Generic
    Proprietary Name DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE
    Proprietary Name Suffix n/a
    Non-Proprietary Name DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route OPHTHALMIC
    Active Ingredient Strength 20; 5
    Active Ingredient Units mg/mL; mg/mL
    Substance Name DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
    Labeler Name Somerset Therapeutics, LLC
    Pharmaceutical Class Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207523
    Listing Certified Through 2024-12-31

    Package

    NDC 70069-0051-12 (70069005112)

    NDC Package Code 70069-051-12
    Billing NDC 70069005112
    Package 12 CARTON in 1 BOX (70069-051-12) / 1 BOTTLE in 1 CARTON (70069-051-01) / 10 mL in 1 BOTTLE
    Marketing Start Date 2019-06-25
    NDC Exclude Flag N
    Pricing Information N/A