NDC 0404-7195

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone

Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone

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 Henry Schein Inc.. The primary component is Neomycin Sulfate; Polymyxin B Sulfate; Bacitracin Zinc; Hydrocortisone.

Product ID0404-7195_539f0f76-f4b1-469e-8fce-be58eb77ae64
NDC0404-7195
Product TypeHuman Prescription Drug
Proprietary NameNeomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone
Generic NameNeomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone
Dosage FormOintment
Route of AdministrationOPHTHALMIC
Marketing Start Date2015-05-13
Marketing CategoryANDA / ANDA
Application NumberANDA065213
Labeler NameHenry Schein Inc.
Substance NameNEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE
Active Ingredient Strength4 mg/g; [USP'U]/g; [USP'U]/g; mg/g
Pharm ClassesAminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0404-7195-01

1 TUBE in 1 CARTON (0404-7195-01) > 3.5 g in 1 TUBE
Marketing Start Date2015-05-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0404-7195-01 [00404719501]

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone OINTMENT
Marketing CategoryANDA
Application NumberANDA065213
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-13

Drug Details

Active Ingredients

IngredientStrength
NEOMYCIN SULFATE3.5 mg/g

OpenFDA Data

SPL SET ID:3899b358-bf5f-49b5-9183-23c910339f75
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1116150
  • UPC Code
  • 0304047195010
  • Pharmacological Class

    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]
    • Polymyxin-class Antibacterial [EPC]
    • Polymyxins [CS]
    • Decreased Cell Wall Synthesis & Repair [PE]
    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Aminoglycoside Antibacterial [EPC]
    • Aminoglycosides [CS]
    • Polymyxin-class Antibacterial [EPC]
    • Polymyxins [CS]
    • Decreased Cell Wall Synthesis & Repair [PE]
    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

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

    NDCBrand NameGeneric Name
    0404-7195Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone
    13985-608Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone
    17478-719Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc, Hydrocortisone
    61570-031CORTISPORINneomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone

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