"70518-4381-0" National Drug Code (NDC)

Polymyxin B Sulfate And Trimethoprim Sulfate 1 BOTTLE in 1 CARTON (70518-4381-0) / 10 mL in 1 BOTTLE
(REMEDYREPACK INC.)

NDC Code70518-4381-0
Package Description1 BOTTLE in 1 CARTON (70518-4381-0) / 10 mL in 1 BOTTLE
Product NDC70518-4381
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePolymyxin B Sulfate And Trimethoprim Sulfate
Non-Proprietary NamePolymyxin B Sulfate And Trimethoprim Sulfate
Dosage FormSOLUTION/ DROPS
UsageOPHTHALMIC
Start Marketing Date20250701
Marketing Category NameANDA
Application NumberANDA211572
ManufacturerREMEDYREPACK INC.
Substance NamePOLYMYXIN B SULFATE; TRIMETHOPRIM
Strength10000; 1
Strength Unit[iU]/mL; mg/mL
Pharmacy ClassesCytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]

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