"53002-9000-1" National Drug Code (NDC)

Neomycin And Polymyxin B Sulfates And Hydrocortisone 1 BOTTLE, DROPPER in 1 CARTON (53002-9000-1) / 10 mL in 1 BOTTLE, DROPPER
(RPK Pharmaceuticals, Inc.)

NDC Code53002-9000-1
Package Description1 BOTTLE, DROPPER in 1 CARTON (53002-9000-1) / 10 mL in 1 BOTTLE, DROPPER
Product NDC53002-9000
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameNeomycin And Polymyxin B Sulfates And Hydrocortisone
Non-Proprietary NameNeomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone
Dosage FormSUSPENSION/ DROPS
UsageAURICULAR (OTIC)
Start Marketing Date19960828
Marketing Category NameANDA
Application NumberANDA064065
ManufacturerRPK Pharmaceuticals, 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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