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    NDC 63187-0669-35 Neomycin and Polymyxin B Sulfates and Dexamethasone 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Details

    Neomycin and Polymyxin B Sulfates and Dexamethasone 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g

    Neomycin and Polymyxin B Sulfates and Dexamethasone is a OPHTHALMIC OINTMENT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE.

    Product Information

    NDC 63187-0669
    Product ID 63187-669_84f8a211-aaba-4d86-b71c-9a0632217c9e
    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 Neomycin and Polymyxin B Sulfates and Dexamethasone
    Proprietary Name Suffix n/a
    Non-Proprietary Name Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form OINTMENT
    Route OPHTHALMIC
    Active Ingredient Strength 1; 3.5; 10000
    Active Ingredient Units mg/g; mg/g; [USP'U]/g
    Substance Name DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
    Labeler Name Proficient Rx LP
    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 ANDA
    Application Number ANDA064063
    Listing Certified Through 2024-12-31

    Package

    NDC 63187-0669-35 (63187066935)

    NDC Package Code 63187-669-35
    Billing NDC 63187066935
    Package 1 TUBE in 1 CARTON (63187-669-35) / 3.5 g in 1 TUBE
    Marketing Start Date 2018-12-01
    NDC Exclude Flag N
    Pricing Information N/A