| NDC Code | 70518-4381-0 |
| Package Description | 1 BOTTLE in 1 CARTON (70518-4381-0) / 10 mL in 1 BOTTLE |
| Product NDC | 70518-4381 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Polymyxin B Sulfate And Trimethoprim Sulfate |
| Non-Proprietary Name | Polymyxin B Sulfate And Trimethoprim Sulfate |
| Dosage Form | SOLUTION/ DROPS |
| Usage | OPHTHALMIC |
| Start Marketing Date | 20250701 |
| Marketing Category Name | ANDA |
| Application Number | ANDA211572 |
| Manufacturer | REMEDYREPACK INC. |
| Substance Name | POLYMYXIN B SULFATE; TRIMETHOPRIM |
| Strength | 10000; 1 |
| Strength Unit | [iU]/mL; mg/mL |
| Pharmacy Classes | Cytochrome 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] |