NDC 53002-9060

Neomycin and Polymyxin B Sulfates and Hydrocortisone

Neomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone

Neomycin and Polymyxin B Sulfates and Hydrocortisone is a Auricular (otic) Solution in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Neomycin Sulfate; Polymyxin B Sulfate; Hydrocortisone.

Product ID53002-9060_21bad580-49e3-4a6e-b7e6-2ca193d2b332
NDC53002-9060
Product TypeHuman Prescription Drug
Proprietary NameNeomycin and Polymyxin B Sulfates and Hydrocortisone
Generic NameNeomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone
Dosage FormSolution
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2003-03-18
Marketing CategoryANDA / ANDA
Application NumberANDA062423
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameNEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
Active Ingredient Strength4 mg/mL; [iU]/mL; mg/mL
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53002-9060-1

10 mL in 1 BOTTLE (53002-9060-1)
Marketing Start Date2017-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-9060-1 [53002906001]

Neomycin and Polymyxin B Sulfates and Hydrocortisone SOLUTION
Marketing CategoryANDA
Application NumberANDA062423
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NEOMYCIN SULFATE3.5 mg/mL

OpenFDA Data

SPL SET ID:2b1b7fdf-bbcf-47dc-9e27-5ddf0e14ba83
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 204423
  • Pharmacological Class

    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]
    • Polymyxin-class Antibacterial [EPC]
    • Polymyxins [CS]
    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Neomycin and Polymyxin B Sulfates and Hydrocortisone" or generic name "Neomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone"

    NDCBrand NameGeneric Name
    10544-912Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
    21695-437Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
    21695-438Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
    24208-631Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
    24208-635Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
    49999-254Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
    49999-439Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone
    50090-0431Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
    50090-0433Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
    50090-2365Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone
    50090-2426Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone
    50436-0737Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
    52959-084Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
    53002-9000Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
    53002-9060Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone
    53002-9061Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
    55700-282Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone
    61314-641Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone
    61314-645Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone
    61314-646Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone
    61919-662NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONENEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
    63187-270Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
    63187-308Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and Hydrocortisone
    63187-568Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone
    63187-648Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisone
    68071-4174Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone
    68071-4577Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone
    68071-4229Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone
    68788-9415Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone
    68788-9924Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone
    70518-0763Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone
    70518-0864Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone
    76413-117Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone
    66267-957Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone
    66267-954Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone
    68788-7684Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone

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