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
NDC Product Code55513-954
Application NumberBLA125147
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateAugust 25, 2021
Generic Namepanitumumab
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
NDC Product Code55513-956
Application NumberBLA125147
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateAugust 25, 2021
Generic Namepanitumumab
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