NDC 53217-289

Neomycin and Polymyxin B Sulfates and Dexamethasone

Neomycin, Polymyxin B Sulfates, Dexamethasone

Neomycin and Polymyxin B Sulfates and Dexamethasone is a Ophthalmic Ointment in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate.

Product ID53217-289_fd06a7c2-f0e0-40d3-9673-44bc0e2ff7bd
NDC53217-289
Product TypeHuman Prescription Drug
Proprietary NameNeomycin and Polymyxin B Sulfates and Dexamethasone
Generic NameNeomycin, Polymyxin B Sulfates, Dexamethasone
Dosage FormOintment
Route of AdministrationOPHTHALMIC
Marketing Start Date2014-07-03
Marketing CategoryANDA / ANDA
Application NumberANDA062938
Labeler NameAidarex Pharmaceuticals LLC
Substance NameDEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active Ingredient Strength1 mg/g; mg/g; [USP'U]/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53217-289-01

1 TUBE in 1 CARTON (53217-289-01) > 3.5 g in 1 TUBE
Marketing Start Date2014-07-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-289-01 [53217028901]

Neomycin and Polymyxin B Sulfates and Dexamethasone OINTMENT
Marketing CategoryANDA
Application NumberANDA062938
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2014-07-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE1 mg/g

OpenFDA Data

SPL SET ID:c44aae7b-3241-4760-a11f-f620871f1466
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309679

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Neomycin and Polymyxin B Sulfates and Dexamethasone" or generic name "Neomycin, Polymyxin B Sulfates, Dexamethasone"

    NDCBrand NameGeneric Name
    0574-4160Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, Dexamethasone
    13985-014Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate, and Dexamethasone
    13985-744Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone
    21695-595Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin B sulfate and dexamethasone
    24208-795Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone
    26637-941Neomycin and Polymyxin B Sulfates and DexamethasoneDexamethasone, Neomycin sulfate, Polymysin B sulfate
    33261-551Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
    49999-141Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
    50090-0571Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, Dexamethasone
    50090-1957Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
    50090-3068Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
    50090-4435Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin and Polymyxin B Sulfates and Dexamethasone
    50090-6181Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone
    53002-9511Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
    53217-289Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, Dexamethasone
    61314-630Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
    61314-631Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin and Polymyxin B Sulfates and Dexamethasone
    61919-113NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEneomycin, polymyxin b sulfates, dexamethasone
    63187-395Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, Dexamethasone
    63187-669Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone
    68071-1744Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, Dexamethasone
    68071-2428Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone
    68071-3359Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
    68071-5281Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin and Polymyxin B Sulfates and Dexamethasone
    68788-6841Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone
    68788-7686Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
    68788-9120Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasone
    68788-9373Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin, Polymyxin B Sulfates, Dexamethasone
    70518-2198Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin and Polymyxin B Sulfates and Dexamethasone
    71205-330Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin and Polymyxin B Sulfates and Dexamethasone
    72189-038NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.