MEPSEVII
These highlights do not include all the information needed to use MEPSEVII safely and effectively. See full prescribing information for MEPSEVII . MEPSEVII ( vestronidase alfa - vjbk ) injection , for intravenous use Initial U.S. Approval: 2017
Approved
Approval ID
925d4e21-fd98-474d-a34d-a0b3558ed750
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2020
Manufacturers
FDA
Ultragenyx Pharmaceutical Inc.
DUNS: 962892019
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
vestronidase alfa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69794-001
Application NumberBLA761047
Product Classification
M
Marketing Category
C73585
G
Generic Name
vestronidase alfa
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 23, 2020
FDA Product Classification
INGREDIENTS (5)
VESTRONIDASE ALFAActive
Quantity: 2 mg in 1 mL
Code: 7XZ4062R17
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Quantity: 3.12 mg in 1 mL
Code: 5QWK665956
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7.88 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HISTIDINEInactive
Quantity: 3.1 mg in 1 mL
Code: 4QD397987E
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 0.1 mg in 1 mL
Code: 7T1F30V5YH
Classification: IACT