| Product NDC: | 63323-393 |
| Proprietary Name: | Colistimethate |
| Non Proprietary Name: | COLISTIMETHATE SODIUM |
| Active Ingredient(s): | 150 mg/2mL & nbsp; COLISTIMETHATE SODIUM |
| Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63323-393 |
| Labeler Name: | APP Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA065364 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20091204 |
| Package NDC: | 63323-393-06 |
| Package Description: | 1 VIAL in 1 BOX (63323-393-06) > 2 mL in 1 VIAL |
| NDC Code | 63323-393-06 |
| Proprietary Name | Colistimethate |
| Package Description | 1 VIAL in 1 BOX (63323-393-06) > 2 mL in 1 VIAL |
| Product NDC | 63323-393 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | COLISTIMETHATE SODIUM |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRAMUSCULAR; INTRAVENOUS |
| Start Marketing Date | 20091204 |
| Marketing Category Name | ANDA |
| Labeler Name | APP Pharmaceuticals, LLC |
| Substance Name | COLISTIMETHATE SODIUM |
| Strength Number | 150 |
| Strength Unit | mg/2mL |
| Pharmaceutical Classes | Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] |