"53217-305-01" National Drug Code (NDC)

Polymyxin B Sulfate And Trimethoprim 10 mL in 1 BOTTLE, PLASTIC (53217-305-01)
(Aidarex Pharmaceuticals LLC)

NDC Code53217-305-01
Package Description10 mL in 1 BOTTLE, PLASTIC (53217-305-01)
Product NDC53217-305
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePolymyxin B Sulfate And Trimethoprim
Non-Proprietary NamePolymyxin B Sulfate And Trimethoprim
Dosage FormSOLUTION
UsageOPHTHALMIC
Start Marketing Date20170427
Marketing Category NameANDA
Application NumberANDA064211
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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