NDC 57237-129

Neomycin and Polymyxin B sulfates, Bacitracin zinc

Neomycin And Polymyxin B Sulfates, Bacitracin Zinc

Neomycin and Polymyxin B sulfates, Bacitracin zinc is a Ophthalmic Ointment in the Human Prescription Drug category. It is labeled and distributed by Citron Pharma Llc. The primary component is Neomycin Sulfate; Polymyxin B Sulfate; Bacitracin Zinc.

Product ID57237-129_b9658136-c2b1-492e-a9ff-8a8d4e5f5ff6
NDC57237-129
Product TypeHuman Prescription Drug
Proprietary NameNeomycin and Polymyxin B sulfates, Bacitracin zinc
Generic NameNeomycin And Polymyxin B Sulfates, Bacitracin Zinc
Dosage FormOintment
Route of AdministrationOPHTHALMIC
Marketing Start Date2017-04-10
Marketing CategoryNDA / NDA
Application NumberNDA050417
Labeler NameCitron Pharma LLC
Substance NameNEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC
Active Ingredient Strength4 mg/g; [USP'U]/g; [USP'U]/g
Pharm ClassesPolymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 57237-129-53

1 TUBE in 1 CARTON (57237-129-53) > 3.5 g in 1 TUBE
Marketing Start Date2017-04-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57237-129-53 [57237012953]

Neomycin and Polymyxin B sulfates, Bacitracin zinc OINTMENT
Marketing CategoryNDA
Application NumberNDA050417
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-04-10
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NEOMYCIN SULFATE3.5 mg/g

OpenFDA Data

SPL SET ID:b9658136-c2b1-492e-a9ff-8a8d4e5f5ff6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308493
  • Pharmacological Class

    • Polymyxin-class Antibacterial [EPC]
    • Polymyxins [CS]
    • Decreased Cell Wall Synthesis & Repair [PE]
    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]

    Medicade Reported Pricing

    57237012953 NEOMYC-BACIT-POLYMIX EYE OINT

    Pricing Unit: GM | Drug Type:

    NDC Crossover Matching brand name "Neomycin and Polymyxin B sulfates, Bacitracin zinc" or generic name "Neomycin And Polymyxin B Sulfates, Bacitracin Zinc"

    NDCBrand NameGeneric Name
    57237-129Neomycin and Polymyxin B sulfates, Bacitracin zincNeomycin and Polymyxin B sulfates, Bacitracin zinc
    70199-010Neomycin and Polymyxin B sulfates, Bacitracin zincNeomycin and Polymyxin B sulfates, Bacitracin zinc

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.