| Product NDC: | 54482-301 |
| Proprietary Name: | Oncaspar |
| Non Proprietary Name: | pegaspargase |
| Active Ingredient(s): | 750 [iU]/mL & nbsp; pegaspargase |
| Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54482-301 |
| Labeler Name: | Sigma-Tau Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | BLA103411 |
| Marketing Category: | BLA |
| Start Marketing Date: | 19940201 |
| Package NDC: | 54482-301-01 |
| Package Description: | 1 VIAL, SINGLE-USE in 1 CARTON (54482-301-01) > 5 mL in 1 VIAL, SINGLE-USE |
| NDC Code | 54482-301-01 |
| Proprietary Name | Oncaspar |
| Package Description | 1 VIAL, SINGLE-USE in 1 CARTON (54482-301-01) > 5 mL in 1 VIAL, SINGLE-USE |
| Product NDC | 54482-301 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | pegaspargase |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAMUSCULAR; INTRAVENOUS |
| Start Marketing Date | 19940201 |
| Marketing Category Name | BLA |
| Labeler Name | Sigma-Tau Pharmaceuticals, Inc. |
| Substance Name | PEGASPARGASE |
| Strength Number | 750 |
| Strength Unit | [iU]/mL |
| Pharmaceutical Classes | Asparaginase [Chemical/Ingredient],Asparagine-specific Enzyme [EPC] |