"53217-244-01" National Drug Code (NDC)

Polymyxin B Sulfate And Trimethoprim 1 BOTTLE, DROPPER in 1 CARTON (53217-244-01) > 10 mL in 1 BOTTLE, DROPPER
(Aidarex Pharmaceuticals LLC)

NDC Code53217-244-01
Package Description1 BOTTLE, DROPPER in 1 CARTON (53217-244-01) > 10 mL in 1 BOTTLE, DROPPER
Product NDC53217-244
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePolymyxin B Sulfate And Trimethoprim
Non-Proprietary NamePolymyxin B Sulfate And Trimethoprim Sulfate
Dosage FormSOLUTION/ DROPS
UsageOPHTHALMIC
Start Marketing Date19970214
Marketing Category NameANDA
Application NumberANDA064120
ManufacturerAidarex Pharmaceuticals LLC
Substance NamePOLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Strength10000; 1
Strength Unit[USP'U]/mL; mg/mL
Pharmacy ClassesPolymyxin-class Antibacterial [EPC],Polymyxins [CS],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]

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