XENPOZYME
These highlights do not include all the information needed to use XENPOZYME safely and effectively. See full prescribing information for XENPOZYME. XENPOZYME (olipudase alfa-rpcp) for injection, for intravenous use Initial U.S. Approval: 2022
Approved
Approval ID
01a910ee-a33e-4be3-ac41-322d64c34311
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2023
Manufacturers
FDA
Genzyme Corporation
DUNS: 025322157
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
olipudase alfa-rpcp
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58468-0050
Application NumberBLA761261
Product Classification
M
Marketing Category
C73585
G
Generic Name
olipudase alfa-rpcp
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 12, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 8.17 mg in 5.1 mL
Code: 593YOG76RN
Classification: IACT
OLIPUDASE ALFAActive
Quantity: 20 mg in 5.1 mL
Code: 6D5766Q4OP
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Quantity: 4.47 mg in 5.1 mL
Code: 70WT22SF4B
Classification: IACT
METHIONINEInactive
Quantity: 74.6 mg in 5.1 mL
Code: AE28F7PNPL
Classification: IACT
SUCROSEInactive
Quantity: 250 mg in 5.1 mL
Code: C151H8M554
Classification: IACT
olipudase alfa-rpcp
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58468-0051
Application NumberBLA761261
Product Classification
M
Marketing Category
C73585
G
Generic Name
olipudase alfa-rpcp
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 12, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Quantity: 0.89 mg in 1.1 mL
Code: 70WT22SF4B
Classification: IACT
OLIPUDASE ALFAActive
Quantity: 4 mg in 1.1 mL
Code: 6D5766Q4OP
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 1.63 mg in 1.1 mL
Code: 593YOG76RN
Classification: IACT
SUCROSEInactive
Quantity: 50 mg in 1.1 mL
Code: C151H8M554
Classification: IACT
METHIONINEInactive
Quantity: 14.92 mg in 1.1 mL
Code: AE28F7PNPL
Classification: IACT