NDC 0574-4160

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 Paddock Laboratories, Llc. The primary component is Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate.

Product ID0574-4160_2b420b06-16b2-42a9-9add-8f42320974be
NDC0574-4160
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 NamePaddock Laboratories, 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 Through2020-12-31

Packaging

NDC 0574-4160-35

1 TUBE in 1 CARTON (0574-4160-35) > 3.5 g in 1 TUBE
Marketing Start Date2014-07-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0574-4160-35 [00574416035]

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

Drug Details

Active Ingredients

IngredientStrength
DEXAMETHASONE1 mg/g

OpenFDA Data

SPL SET ID:c8ae4afe-4f06-4441-9c5b-52f485f8f2f5
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]
    • 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.