Home NDC 61755-005 EYLEA
Product NDC 61755-005
11-digit product format 617550005
Labeler code 61755
Product ID 61755-005_130874ea-1e06-4ffc-b632-1dc8c73a9905
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name aflibercept
Dosage form INJECTION, SOLUTION
Route INTRAVITREAL
Labeler Regeneron Pharmaceuticals, Inc.
Application BLA125387
Marketing category BLA
Marketing start 2011-11-21
Substance AFLIBERCEPT
Active strength 40 mg/mL
Pharmacologic classes Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base EYLEA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AFLIBERCEPT 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15C2VL427D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1232154 Internal RxNorm lookup 1232159 Internal RxNorm lookup 2693564 Internal RxNorm lookup 2693567 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61755-005-01 EYLEA 1 in 1 CARTON INJECTION, SOLUTION 1 39 61755-005-01 EYLEA 0.05 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 0.05 39 61755-005-02 EYLEA 0.05 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 0.05 39 61755-005-02 EYLEA 1 in 1 CARTON INJECTION, SOLUTION 1 39 61755-005-54 EYLEA 0.05 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 0.05 39 61755-005-54 EYLEA 1 in 1 CARTON INJECTION, SOLUTION 1 39 61755-005-55 EYLEA 1 in 1 CARTON INJECTION, SOLUTION 1 39 61755-005-55 EYLEA 0.05 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 0.05 39
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded aflibercept ACTIVE INGREDIENT 15C2VL427D EYLEA (AFLIBERCEPT) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC.] 12 aflibercept ACTIVE MOIETY 15C2VL427D EYLEA (AFLIBERCEPT) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC.] 12 polysorbate 20 INACTIVE INGREDIENT 7T1F30V5YH EYLEA (AFLIBERCEPT) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC.] 12 sodium chloride INACTIVE INGREDIENT 451W47IQ8X EYLEA (AFLIBERCEPT) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC.] 12 sodium phosphate INACTIVE INGREDIENT SE337SVY37 EYLEA (AFLIBERCEPT) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC.] 12 sucrose INACTIVE INGREDIENT C151H8M554 EYLEA (AFLIBERCEPT) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61755-005 EYLEA (AFLIBERCEPT) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC.] 38 Current NDC, Legacy NDC, 8 package rows 20241024_f96cfd69-da34-41ee-90a9-610a4655cd1c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EYLEA AFLIBERCEPT Regeneron Pharmaceuticals, Inc. f96cfd69-da34-41ee-90a9-610a4655cd1c 2026-07-07 Warnings, Adverse reactions Exact identifier application number: BLA125387 ndc (product): 61755-005
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125387 Eylea aflibercept 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 61755-005-01 61755000501 1 SYRINGE, GLASS in 1 CARTON (61755-005-01) / .05 mL in 1 SYRINGE, GLASS 2019-12-09 0000-00-00 No No Current 61755-005-02 61755000502 1 VIAL, SINGLE-USE in 1 CARTON (61755-005-02) / .05 mL in 1 VIAL, SINGLE-USE 2011-11-21 0000-00-00 No No Current 61755-005-54 61755000554 1 SYRINGE, GLASS in 1 CARTON (61755-005-54) / .05 mL in 1 SYRINGE, GLASS 2019-12-09 0000-00-00 No No Current 61755-005-55 61755000555 1 VIAL, SINGLE-USE in 1 CARTON (61755-005-55) / .05 mL in 1 VIAL, SINGLE-USE 2014-01-16 0000-00-00 No No Current