EYLEA HD
These highlights do not include all the information needed to use EYLEA HD safely and effectively. See full prescribing information for EYLEA HD. EYLEA HD (aflibercept) injection, for intravitreal use Initial U.S. Approval: 2011
Approved
Approval ID
86d8848b-111b-4da9-8957-7cccef1b8f66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 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.
aflibercept
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61755-050
Application NumberBLA761355
Product Classification
M
Marketing Category
C73585
G
Generic Name
aflibercept
Product Specifications
Route of AdministrationINTRAVITREAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (6)
afliberceptActive
Quantity: 8 mg in 0.07 mL
Code: 15C2VL427D
Classification: ACTIB
polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
arginine hydrochlorideInactive
Code: F7LTH1E20Y
Classification: IACT
histidineInactive
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6P
Classification: IACT
aflibercept
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61755-051
Application NumberBLA761355
Product Classification
M
Marketing Category
C73585
G
Generic Name
aflibercept
Product Specifications
Route of AdministrationINTRAVITREAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (6)
polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
arginine hydrochlorideInactive
Code: F7LTH1E20Y
Classification: IACT
histidineInactive
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6P
Classification: IACT
afliberceptActive
Quantity: 8 mg in 0.07 mL
Code: 15C2VL427D
Classification: ACTIB
sucroseInactive
Code: C151H8M554
Classification: IACT