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    NDC 63187-0193-10 Trimethoprim sulfate and Polymyxin B sulfate 10000; 1 [USP'U]/mL; mg/mL Details

    Trimethoprim sulfate and Polymyxin B sulfate 10000; 1 [USP'U]/mL; mg/mL

    Trimethoprim sulfate and Polymyxin B sulfate is a OPHTHALMIC SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE.

    Product Information

    NDC 63187-0193
    Product ID 63187-193_a0deddd4-f2c7-4594-ac0d-1ed4ce48b891
    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 Trimethoprim sulfate and Polymyxin B sulfate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Trimethoprim sulfate and Polymyxin B sulfate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route OPHTHALMIC
    Active Ingredient Strength 10000; 1
    Active Ingredient Units [USP'U]/mL; mg/mL
    Substance Name POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
    Labeler Name Proficient Rx LP
    Pharmaceutical Class Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA065006
    Listing Certified Through 2024-12-31

    Package

    NDC 63187-0193-10 (63187019310)

    NDC Package Code 63187-193-10
    Billing NDC 63187019310
    Package 1 BOTTLE, DROPPER in 1 CARTON (63187-193-10) / 10 mL in 1 BOTTLE, DROPPER
    Marketing Start Date 2019-01-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 2c5579eb-ad81-415e-8dcb-9f1c94c897ae Details

    Revised: 1/2021