EYLEA
These highlights do not include all the information needed to use EYLEA safely and effectively. See full prescribing information for EYLEA. EYLEA (aflibercept) injection, for intravitreal use Initial U.S. Approval: 2011
Approved
Approval ID
f96cfd69-da34-41ee-90a9-610a4655cd1c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
Regeneron Pharmaceuticals, Inc.
DUNS: 194873139
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
aflibercept
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61755-005
Application NumberBLA125387
Product Classification
M
Marketing Category
C73585
G
Generic Name
aflibercept
Product Specifications
Route of AdministrationINTRAVITREAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (5)
sodium phosphateInactive
Code: SE337SVY37
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
afliberceptActive
Quantity: 40 mg in 1 mL
Code: 15C2VL427D
Classification: ACTIB
polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT