BORTEZOMIB
These highlights do not include all the information needed to use BORTEZOMIB FOR INJECTION safely and effectively. See full prescribing information for BORTEZOMIB FOR INJECTION. BORTEZOMIB for injection, for subcutaneous or intravenous useInitial U.S. Approval: 2003
Approved
Approval ID
9fdf6169-699f-40eb-bda1-760253062b3c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 27, 2023
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BORTEZOMIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-1703
Application NumberNDA209191
Product Classification
M
Marketing Category
C73594
G
Generic Name
BORTEZOMIB
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 1, 2022
FDA Product Classification
INGREDIENTS (2)
BORTEZOMIBActive
Quantity: 2.5 mg in 1 1
Code: 69G8BD63PP
Classification: ACTIB
MANNITOLInactive
Quantity: 25 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
BORTEZOMIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-1704
Application NumberNDA209191
Product Classification
M
Marketing Category
C73594
G
Generic Name
BORTEZOMIB
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 1, 2022
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Quantity: 10 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
BORTEZOMIBActive
Quantity: 1 mg in 1 1
Code: 69G8BD63PP
Classification: ACTIB