| Product NDC: | 54092-701 |
| Proprietary Name: | VPRIV |
| Non Proprietary Name: | velaglucerase alfa |
| Active Ingredient(s): | 2.5 mg/mL & nbsp; velaglucerase alfa |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54092-701 |
| Labeler Name: | Shire US Manufacturing Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022575 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20100226 |
| Package NDC: | 54092-701-04 |
| Package Description: | 1 VIAL, GLASS in 1 BOX (54092-701-04) > 4 mL in 1 VIAL, GLASS |
| NDC Code | 54092-701-04 |
| Proprietary Name | VPRIV |
| Package Description | 1 VIAL, GLASS in 1 BOX (54092-701-04) > 4 mL in 1 VIAL, GLASS |
| Product NDC | 54092-701 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | velaglucerase alfa |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20100226 |
| Marketing Category Name | NDA |
| Labeler Name | Shire US Manufacturing Inc. |
| Substance Name | VELAGLUCERASE ALFA |
| Strength Number | 2.5 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC] |