YERVOY
These highlights do not include all the information needed to use YERVOY safely and effectively. See full prescribing information for YERVOY. YERVOY (ipilimumab) injection, for intravenous useInitial U.S. Approval: 2011
Approved
Approval ID
2265ef30-253e-11df-8a39-0800200c9a66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2023
Manufacturers
FDA
E.R. Squibb & Sons, L.L.C.
DUNS: 011550092
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ipilimumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0003-2328
Application NumberBLA125377
Product Classification
M
Marketing Category
C73585
G
Generic Name
ipilimumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 19, 2015
FDA Product Classification
INGREDIENTS (7)
IPILIMUMABActive
Quantity: 5 mg in 1 mL
Code: 6T8C155666
Classification: ACTIB
TROMETHAMINE HYDROCHLORIDEInactive
Quantity: 3.15 mg in 1 mL
Code: 383V75M34E
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 5.85 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
MANNITOLInactive
Quantity: 10 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
PENTETIC ACIDInactive
Quantity: 0.04 mg in 1 mL
Code: 7A314HQM0I
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ipilimumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0003-2327
Application NumberBLA125377
Product Classification
M
Marketing Category
C73585
G
Generic Name
ipilimumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 19, 2015
FDA Product Classification
INGREDIENTS (7)
IPILIMUMABActive
Quantity: 5 mg in 1 mL
Code: 6T8C155666
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 5.85 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
TROMETHAMINE HYDROCHLORIDEInactive
Quantity: 3.15 mg in 1 mL
Code: 383V75M34E
Classification: IACT
MANNITOLInactive
Quantity: 10 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
PENTETIC ACIDInactive
Quantity: 0.04 mg in 1 mL
Code: 7A314HQM0I
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT