OCREVUS
These highlights do not include all the information needed to use OCREVUS safely and effectively. See full prescribing information for OCREVUS. OCREVUS (ocrelizumab) injection, for intravenous use Initial U.S. Approval: 2017
Approved
Approval ID
9da42362-3bb5-4b83-b4bb-b59fd4e55f0d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2024
Manufacturers
FDA
Genentech, Inc.
DUNS: 080129000
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ocrelizumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-150
Application NumberBLA761053
Product Classification
M
Marketing Category
C73585
G
Generic Name
ocrelizumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 25, 2024
FDA Product Classification
INGREDIENTS (6)
SODIUM ACETATEInactive
Quantity: 21.4 mg in 10 mL
Code: 4550K0SC9B
Classification: IACT
OCRELIZUMABActive
Quantity: 300 mg in 10 mL
Code: A10SJL62JY
Classification: ACTIB
ACETIC ACIDInactive
Quantity: 2.5 mg in 10 mL
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TREHALOSE DIHYDRATEInactive
Quantity: 400 mg in 10 mL
Code: 7YIN7J07X4
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 2 mg in 10 mL
Code: 7T1F30V5YH
Classification: IACT