VPRIV
These highlights do not include all the information needed to use VPRIV safely and effectively. See full prescribing information for VPRIV. VPRIV (velaglucerase alfa) for injection, for intravenous use Initial U.S. Approval: 2010
Approved
Approval ID
ca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2022
Manufacturers
FDA
Takeda Pharmaceuticals America, Inc.
DUNS: 039997266
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
velaglucerase alfa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-701
Application NumberBLA022575
Product Classification
M
Marketing Category
C73585
G
Generic Name
velaglucerase alfa
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 30, 2021
FDA Product Classification
INGREDIENTS (5)
VELAGLUCERASE ALFAActive
Quantity: 2.5 mg in 1 mL
Code: 23HYE36B0I
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Quantity: 1.26 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 0.11 mg in 1 mL
Code: 7T1F30V5YH
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 12.94 mg in 1 mL
Code: B22547B95K
Classification: IACT
SUCROSEInactive
Quantity: 50 mg in 1 mL
Code: C151H8M554
Classification: IACT