Vectibix
These highlights do not include all the information needed to use VECTIBIX safely and effectively. See full prescribing information for VECTIBIX . VECTIBIX (panitumumab) I njection for intravenous use Initial U.S. Approval: 200 6
Approved
Approval ID
e0fa4bca-f245-4d92-ae29-b0c630a315c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 25, 2021
Manufacturers
FDA
Amgen Inc
DUNS: 039976196
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
panitumumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-954
Application NumberBLA125147
Product Classification
M
Marketing Category
C73585
G
Generic Name
panitumumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 25, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Quantity: 29 mg in 5 mL
Code: 451W47IQ8X
Classification: IACT
PANITUMUMABActive
Quantity: 100 mg in 5 mL
Code: 6A901E312A
Classification: ACTIB
SODIUM ACETATEInactive
Quantity: 34 mg in 5 mL
Code: 4550K0SC9B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
panitumumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-956
Application NumberBLA125147
Product Classification
M
Marketing Category
C73585
G
Generic Name
panitumumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 25, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM ACETATEInactive
Quantity: 136 mg in 20 mL
Code: 4550K0SC9B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PANITUMUMABActive
Quantity: 400 mg in 20 mL
Code: 6A901E312A
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 117 mg in 20 mL
Code: 451W47IQ8X
Classification: IACT