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    NDC 00404-7194-01 Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc 400; 3.5; 10000 [USP'U]/g; mg/g; [USP'U]/g Details

    Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc 400; 3.5; 10000 [USP'U]/g; mg/g; [USP'U]/g

    Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc is a OPHTHALMIC OINTMENT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Henry Schein Inc.. The primary component is BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE.

    Product Information

    NDC 00404-7194
    Product ID 0404-7194_d6ca470d-dd66-45d4-b2b5-23090c9223b6
    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 Bacitracin Zinc
    Proprietary Name Suffix n/a
    Non-Proprietary Name Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form OINTMENT
    Route OPHTHALMIC
    Active Ingredient Strength 400; 3.5; 10000
    Active Ingredient Units [USP'U]/g; mg/g; [USP'U]/g
    Substance Name BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
    Labeler Name Henry Schein Inc.
    Pharmaceutical Class Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA065088
    Listing Certified Through 2023-12-31

    Package

    NDC 00404-7194-01 (00404719401)

    NDC Package Code 0404-7194-01
    Billing NDC 00404719401
    Package 1 TUBE in 1 CARTON (0404-7194-01) / 3.5 g in 1 TUBE
    Marketing Start Date 2015-05-13
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 02af2a5f-32fb-460b-b29f-7b18cb95204c Details

    Revised: 2/2022