ll rights reserved.
Issue Date: October 2016
Initial U.S. Approval: 2011
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PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 2 mg/0.05 mL Vial Carton
NDC 61755-005-02
EYLEA®
(aflibercept) Injection
For Intravitreal Injection
2 mg/0.05 mL
Single-use Vial
Carton contents: Each EYLEA carton contains
one single-use, 3-mL, glass vial of EYLEA
one 19-gauge x 1½-inch, 5-micron, filter needle
for withdrawal of the vial contents (filter needle not
to be used for intravitreal injection)
one 30-gauge x ½-inch needle for intravitreal injection
one 1-mL plastic syringe for administration
one package insert
Rx ONLY
PRINCIPAL DISPLAY PANEL - 2 mg/0.05 mL Vial Carton
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INGREDIENTS AND APPEARANCE
EYLEA
aflibercept injection, solution
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61755-005
Route of Administration INTRAVITREAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
aflibercept (UNII: 15C2VL427D) (aflibercept - UNII:15C2VL427D) aflibercept 40 mg in 1 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
sodium phosphate (UNII: SE337SVY37)
sodium chloride (UNII: 451W47IQ8X)
polysorbate 20 (UNII: 7T1F30V5YH)
sucrose (UNII: C151H8M554)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61755-005-02 1 in 1 CARTON 11/21/2011
1 0.05 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2 NDC:61755-005-55 1 in 1 CARTON 01/16/2014
2 0.05 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125387 11/21/2011
LABELER - REGENERON PHARMACEUTICALS, INC. (194873139)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Regeneron Pharmaceuticals, Inc. 945589711 API MANUFACTURE(61755-005) , ANALYSIS(61755-005) , LABEL(61755-005) , MANUFACTURE(61755-005) |
