| Product NDC: | 57902-249 |
| Proprietary Name: | ERWINAZE |
| Non Proprietary Name: | Asparaginase |
| Active Ingredient(s): | 10000 [iU]/mL & nbsp; Asparaginase |
| Administration Route(s): | INTRAMUSCULAR |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 57902-249 |
| Labeler Name: | Jazz Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | BLA125359 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20111118 |
| Package NDC: | 57902-249-05 |
| Package Description: | 5 VIAL, GLASS in 1 CARTON (57902-249-05) > 1 mL in 1 VIAL, GLASS (57902-249-01) |
| NDC Code | 57902-249-05 |
| Proprietary Name | ERWINAZE |
| Package Description | 5 VIAL, GLASS in 1 CARTON (57902-249-05) > 1 mL in 1 VIAL, GLASS (57902-249-01) |
| Product NDC | 57902-249 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Asparaginase |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRAMUSCULAR |
| Start Marketing Date | 20111118 |
| Marketing Category Name | BLA |
| Labeler Name | Jazz Pharmaceuticals, Inc. |
| Substance Name | ASPARAGINASE |
| Strength Number | 10000 |
| Strength Unit | [iU]/mL |
| Pharmaceutical Classes | Asparaginase [Chemical/Ingredient],Asparagine-specific Enzyme [EPC] |