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    NDC 00078-0792-05 Maxitrol 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Details

    Maxitrol 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL

    Maxitrol is a OPHTHALMIC SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE.

    Product Information

    NDC 00078-0792
    Product ID 0078-0792_0ab4f06d-887e-afc2-e063-6394a90a4cb1
    Associated GPIs
    GCN Sequence Number 048547
    GCN Sequence Number Description neomycin/polymyxin B/dexametha DROPS SUSP 0.1 % OPHTHALMIC
    HIC3 Q6I
    HIC3 Description EYE ANTIBIOTIC AND GLUCOCORTICOID COMBINATIONS
    GCN 14286
    HICL Sequence Number 003523
    HICL Sequence Number Description NEOMYCIN/POLYMYXIN B SULFATE/DEXAMETHASONE
    Brand/Generic Brand
    Proprietary Name Maxitrol
    Proprietary Name Suffix n/a
    Non-Proprietary Name neomycin sulfate, polymyxin b sulfate and dexamethasone
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SUSPENSION
    Route OPHTHALMIC
    Active Ingredient Strength 1; 3.5; 10000
    Active Ingredient Units mg/mL; mg/mL; [USP'U]/mL
    Substance Name DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
    Labeler Name Novartis Pharmaceuticals Corporation
    Pharmaceutical Class Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA050023
    Listing Certified Through n/a

    Package

    NDC 00078-0792-05 (00078079205)

    NDC Package Code 0078-0792-05
    Billing NDC 00078079205
    Package 5 mL in 1 BOTTLE, PLASTIC (0078-0792-05)
    Marketing Start Date 2022-12-01
    NDC Exclude Flag N
    Pricing Information N/A