PADCEV
These highlights do not include all the information needed to use PADCEV safely and effectively. See full prescribing information for PADCEV. PADCEV (enfortumab vedotin-ejfv) for injection, for intravenous useInitial U.S. Approval: 2019
Approved
Approval ID
b5631d3e-4604-4363-8f20-11dfc5a4a8ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
SEAGEN INC.
DUNS: 028484371
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ENFORTUMAB VEDOTIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51144-020
Application NumberBLA761137
Product Classification
M
Marketing Category
C73585
G
Generic Name
ENFORTUMAB VEDOTIN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (5)
POLYSORBATE 20Inactive
Quantity: 0.4 mg in 2 mL
Code: 7T1F30V5YH
Classification: IACT
ENFORTUMAB VEDOTINActive
Quantity: 20 mg in 2 mL
Code: DLE8519RWM
Classification: ACTIB
HISTIDINEInactive
Quantity: 2.8 mg in 2 mL
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 4.62 mg in 2 mL
Code: X573657P6P
Classification: IACT
TREHALOSE DIHYDRATEInactive
Quantity: 110 mg in 2 mL
Code: 7YIN7J07X4
Classification: IACT
ENFORTUMAB VEDOTIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51144-030
Application NumberBLA761137
Product Classification
M
Marketing Category
C73585
G
Generic Name
ENFORTUMAB VEDOTIN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2022
FDA Product Classification
INGREDIENTS (5)
HISTIDINEInactive
Quantity: 4.2 mg in 3 mL
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 6.93 mg in 3 mL
Code: X573657P6P
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 0.6 mg in 3 mL
Code: 7T1F30V5YH
Classification: IACT
ENFORTUMAB VEDOTINActive
Quantity: 30 mg in 3 mL
Code: DLE8519RWM
Classification: ACTIB
TREHALOSE DIHYDRATEInactive
Quantity: 165 mg in 3 mL
Code: 7YIN7J07X4
Classification: IACT