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    NDC 69396-0002-22 Triple Antibiotic 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g Details

    Triple Antibiotic 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g

    Triple Antibiotic is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by TRIFECTA PHARMACEUTICALS USA LLC. The primary component is BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE.

    Product Information

    NDC 69396-0002
    Product ID 69396-002_fbe78692-c017-4e0c-e053-6294a90a7b3a
    Associated GPIs 90109803104200
    GCN Sequence Number 007694
    GCN Sequence Number Description neomycin/bacitracin/polymyxinB OINT. (G) 3.5-400-5K TOPICAL
    HIC3 Q5W
    HIC3 Description TOPICAL ANTIBIOTICS
    GCN 85459
    HICL Sequence Number 033356
    HICL Sequence Number Description NEOMYCIN SULFATE/BACITRACIN ZINC/POLYMYXIN B
    Brand/Generic Brand
    Proprietary Name Triple Antibiotic
    Proprietary Name Suffix n/a
    Non-Proprietary Name Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.
    Product Type HUMAN OTC DRUG
    Dosage Form OINTMENT
    Route TOPICAL
    Active Ingredient Strength 400; 3.5; 5000
    Active Ingredient Units [USP'U]/g; mg/g; [USP'U]/g
    Substance Name BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
    Labeler Name TRIFECTA PHARMACEUTICALS USA LLC
    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 OTC MONOGRAPH FINAL
    Application Number part333B
    Listing Certified Through 2024-12-31

    Package

    NDC 69396-0002-22 (69396000222)

    NDC Package Code 69396-002-22
    Billing NDC 69396000222
    Package 1 TUBE in 1 BOX (69396-002-22) / 57 g in 1 TUBE
    Marketing Start Date 2022-02-01
    NDC Exclude Flag N
    Pricing Information N/A