Evkeeza
These highlights do not include all the information needed to use EVKEEZA safely and effectively. See full prescribing information for EVKEEZA. EVKEEZA (evinacumab-dgnb) injection, for intravenous use Initial U.S. Approval: 2021
Approved
Approval ID
73412138-6d8f-4ea6-bb72-a740190470ff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 30, 2023
Manufacturers
FDA
Regeneron Pharmaceuticals, Inc.
DUNS: 194873139
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
evinacumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61755-013
Application NumberBLA761181
Product Classification
M
Marketing Category
C73585
G
Generic Name
evinacumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 30, 2023
FDA Product Classification
INGREDIENTS (7)
HistidineInactive
Quantity: 0.74 mg in 1 mL
Code: 4QD397987E
Classification: IACT
evinacumabActive
Quantity: 150 mg in 1 mL
Code: T8B2ORP1DW
Classification: ACTIB
Histidine monohydrochloride monohydrateInactive
Quantity: 1.1 mg in 1 mL
Code: X573657P6P
Classification: IACT
ProlineInactive
Quantity: 30 mg in 1 mL
Code: 9DLQ4CIU6V
Classification: IACT
Polysorbate 80Inactive
Quantity: 1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
Arginine hydrochlorideInactive
Quantity: 14.75 mg in 1 mL
Code: F7LTH1E20Y
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
evinacumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61755-010
Application NumberBLA761181
Product Classification
M
Marketing Category
C73585
G
Generic Name
evinacumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 30, 2023
FDA Product Classification
INGREDIENTS (7)
evinacumabActive
Quantity: 150 mg in 1 mL
Code: T8B2ORP1DW
Classification: ACTIB
ProlineInactive
Quantity: 30 mg in 1 mL
Code: 9DLQ4CIU6V
Classification: IACT
Histidine monohydrochloride monohydrateInactive
Quantity: 1.1 mg in 1 mL
Code: X573657P6P
Classification: IACT
HistidineInactive
Quantity: 0.74 mg in 1 mL
Code: 4QD397987E
Classification: IACT
Polysorbate 80Inactive
Quantity: 1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Arginine hydrochlorideInactive
Quantity: 14.75 mg in 1 mL
Code: F7LTH1E20Y
Classification: IACT