| 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] |