Product NDC: | 54396-801 |
Proprietary Name: | Krystexxa |
Non Proprietary Name: | pegloticase |
Active Ingredient(s): | 8 mg/mL & nbsp; pegloticase |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54396-801 |
Labeler Name: | Savient Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | BLA125293 |
Marketing Category: | BLA |
Start Marketing Date: | 20100914 |
Package NDC: | 54396-801-01 |
Package Description: | 1 VIAL in 1 CARTON (54396-801-01) > 1 mL in 1 VIAL |
NDC Code | 54396-801-01 |
Proprietary Name | Krystexxa |
Package Description | 1 VIAL in 1 CARTON (54396-801-01) > 1 mL in 1 VIAL |
Product NDC | 54396-801 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | pegloticase |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20100914 |
Marketing Category Name | BLA |
Labeler Name | Savient Pharmaceuticals, Inc. |
Substance Name | PEGLOTICASE |
Strength Number | 8 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Urate Oxidase [Chemical/Ingredient],Uric Acid-specific Enzyme [EPC] |