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    NDC 13985-0608-03 Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone 400; 10; 3.5; 10000 [USP'U]/g; mg/g; mg/g; [USP'U]/g Details

    Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone 400; 10; 3.5; 10000 [USP'U]/g; mg/g; mg/g; [USP'U]/g

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

    Product Information

    NDC 13985-0608
    Product ID 13985-608_8e99f613-0575-4a6f-85cb-a2e61f11cf5a
    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, Bacitracin Zinc, and Hydrocortisone
    Proprietary Name Suffix n/a
    Non-Proprietary Name Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form OINTMENT
    Route OPHTHALMIC
    Active Ingredient Strength 400; 10; 3.5; 10000
    Active Ingredient Units [USP'U]/g; mg/g; mg/g; [USP'U]/g
    Substance Name BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
    Labeler Name MWI
    Pharmaceutical Class Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA065213
    Listing Certified Through 2023-12-31

    Package

    NDC 13985-0608-03 (13985060803)

    NDC Package Code 13985-608-03
    Billing NDC 13985060803
    Package 1 TUBE in 1 CARTON (13985-608-03) / 3.5 g in 1 TUBE
    Marketing Start Date 2015-03-23
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL f914f577-32aa-4b7a-9996-ca24b34f022d Details

    Revised: 2/2022