NDC 53210-1003

Antibiotic

Neomycin Sulfate

Antibiotic is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Morales Distributors Inc. The primary component is Neomycin Sulfate.

Product ID53210-1003_e90595b3-d065-4c09-afbd-7c3ae3e95bd4
NDC53210-1003
Product TypeHuman Otc Drug
Proprietary NameAntibiotic
Generic NameNeomycin Sulfate
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2012-09-25
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333B
Labeler NameMorales Distributors Inc
Substance NameNEOMYCIN SULFATE
Active Ingredient Strength4 mg/g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53210-1003-0

1 TUBE in 1 BOX (53210-1003-0) > 28 g in 1 TUBE
Marketing Start Date2012-09-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53210-1003-0 [53210100300]

Antibiotic OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart333B
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-09-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NEOMYCIN SULFATE3.5 mg/g

OpenFDA Data

SPL SET ID:695bfb1f-4648-458b-bab5-30dc3ff8748d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311928
  • NDC Crossover Matching brand name "Antibiotic" or generic name "Neomycin Sulfate"

    NDCBrand NameGeneric Name
    0363-0018AntibioticBacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
    11822-0044AntibioticBacitracin Zinc, Polymyxin B Sulfate
    30142-744AntibioticNeomycin, Polymyxin B, Pramoxine HCl
    36800-536Antibioticbacitracin
    37808-005antibioticNeomycin, Polymyxin B, Pramoxine HCl
    41250-536antibioticBacitracin
    49348-154antibioticBacitracin Zinc
    50090-2742antibioticBacitracin Zinc
    51316-044AntibioticBacitracin Zinc, Polymyxin B Sulfate
    53210-1003AntibioticNEOMYCIN SULFATE
    55550-730Antibioticneomycin sulfate
    68599-1183AntibioticAntibiotic
    69842-199AntibioticAntibiotic
    72663-560AntibioticAntibiotic
    58988-0038AntibioticAntibiotic
    67510-0066AntibioticAntibiotic
    70000-0070AntibioticAntibiotic
    51141-0066Antibiotic OintmentNeomycin Sulfate
    52599-282BaclezeneNeomycin Sulfate
    0924-5620First Aid Only Neomycin Antibioticneomycin sulfate
    0498-0730NeomycinAntibiotic
    0093-1177Neomycin SulfateNeomycin Sulfate
    0527-1210Neomycin SulfateNeomycin Sulfate
    39822-0310Neomycin SulfateNeomycin Sulfate
    50383-565Neomycin SulfateNeomycin Sulfate
    51991-738NEOMYCIN SULFATENEOMYCIN SULFATE
    53145-056Pomada de SulfaNeomycin sulfate
    48201-101POMADA SULFA FIRST AID ANTIBIOTICNEOMYCIN SULFATE
    48201-103POMADA SULFA FIRST AID ANTIBIOTICNEOMYCIN SULFATE
    54312-019VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTICNEOMYCIN SULFATE

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