NDC Code | 63323-321-12 |
Package Description | 10 VIAL in 1 TRAY (63323-321-12) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-321-02) |
Product NDC | 63323-321 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Polymyxin B |
Non-Proprietary Name | Polymyxin B Sulfate |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Usage | INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC |
Start Marketing Date | 20091117 |
Marketing Category Name | ANDA |
Application Number | ANDA065372 |
Manufacturer | Fresenius Kabi USA, LLC |
Substance Name | POLYMYXIN B SULFATE |
Strength | 500000 |
Strength Unit | [USP'U]/1 |
Pharmacy Classes | Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |