| 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] |