| Product NDC: | 25021-117 | 
| Proprietary Name: | Polymyxin B | 
| Non Proprietary Name: | Polymyxin B Sulfate | 
| Active Ingredient(s): | 500000 [iU]/1 & nbsp; Polymyxin B Sulfate | 
| Administration Route(s): | INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC | 
| Dosage Form(s): | INJECTION, POWDER, FOR SOLUTION | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 25021-117 | 
| Labeler Name: | Sagent Pharmaceuticals | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA090110 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20110801 | 
| Package NDC: | 25021-117-10 | 
| Package Description: | 10 VIAL in 1 CARTON (25021-117-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 
| NDC Code | 25021-117-10 | 
| Proprietary Name | Polymyxin B | 
| Package Description | 10 VIAL in 1 CARTON (25021-117-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 
| Product NDC | 25021-117 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Polymyxin B Sulfate | 
| Dosage Form Name | INJECTION, POWDER, FOR SOLUTION | 
| Route Name | INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC | 
| Start Marketing Date | 20110801 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Sagent Pharmaceuticals | 
| Substance Name | POLYMYXIN B SULFATE | 
| Strength Number | 500000 | 
| Strength Unit | [iU]/1 | 
| Pharmaceutical Classes | Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] |