"70518-0763-0" National Drug Code (NDC)

Neomycin And Polymyxin B Sulfates And Hydrocortisone 1 BOTTLE, DROPPER in 1 CARTON (70518-0763-0) / 10 mL in 1 BOTTLE, DROPPER
(REMEDYREPACK INC.)

NDC Code70518-0763-0
Package Description1 BOTTLE, DROPPER in 1 CARTON (70518-0763-0) / 10 mL in 1 BOTTLE, DROPPER
Product NDC70518-0763
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameNeomycin And Polymyxin B Sulfates And Hydrocortisone
Non-Proprietary NameNeomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
Dosage FormSOLUTION/ DROPS
UsageAURICULAR (OTIC)
Start Marketing Date20171006
Marketing Category NameANDA
Application NumberANDA064053
ManufacturerREMEDYREPACK INC.
Substance NameHYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Strength10; 3.5; 10000
Strength Unitmg/mL; mg/mL; [USP'U]/mL
Pharmacy ClassesAminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]

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