| Product NDC: | 60977-319 |
| Proprietary Name: | HYLENEX Recombinant |
| Non Proprietary Name: | Hyaluronidase Recombinant Human |
| Active Ingredient(s): | 150 [USP'U]/mL & nbsp; Hyaluronidase Recombinant Human |
| Administration Route(s): | SUBCUTANEOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 60977-319 |
| Labeler Name: | Baxter Healthcare Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021859 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20051202 |
| Package NDC: | 60977-319-03 |
| Package Description: | 4 BOX in 1 CARTON (60977-319-03) > 1 VIAL, SINGLE-DOSE in 1 BOX (60977-319-02) > 1 mL in 1 VIAL, SINGLE-DOSE (60977-319-44) |
| NDC Code | 60977-319-03 |
| Proprietary Name | HYLENEX Recombinant |
| Package Description | 4 BOX in 1 CARTON (60977-319-03) > 1 VIAL, SINGLE-DOSE in 1 BOX (60977-319-02) > 1 mL in 1 VIAL, SINGLE-DOSE (60977-319-44) |
| Product NDC | 60977-319 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Hyaluronidase Recombinant Human |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | SUBCUTANEOUS |
| Start Marketing Date | 20051202 |
| Marketing Category Name | NDA |
| Labeler Name | Baxter Healthcare Corporation |
| Substance Name | HYALURONIDASE RECOMBINANT HUMAN |
| Strength Number | 150 |
| Strength Unit | [USP'U]/mL |
| Pharmaceutical Classes | Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] |