NDC 61755-005

EYLEA

Aflibercept

EYLEA is a Intravitreal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Regeneron Pharmaceuticals, Inc.. The primary component is Aflibercept.

• Product ID: 61755-005_15a660b3-2b8e-4eb4-ab92-b064d05b82bc
• NDC: 61755-005
• Product Type: Human Prescription Drug
• Proprietary Name: EYLEA
• Generic Name: Aflibercept
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVITREAL
• Marketing Start Date: 2011-11-21
• Marketing Category: BLA / BLA
• Application Number: BLA125387
• Labeler Name: Regeneron Pharmaceuticals, Inc.
• Substance Name: AFLIBERCEPT
• Active Ingredient Strength: 40 mg/mL
• Pharm Classes: Vascular Endothelial Growth Factor Inhibitor [EPC],Vascular Endothelial Growth Factor Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 61755-005-01

1 SYRINGE, GLASS in 1 CARTON (61755-005-01) > .05 mL in 1 SYRINGE, GLASS

• Marketing Start Date: 2019-12-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61755-005-02 [61755000502]

EYLEA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125387
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-11-21

NDC 61755-005-55 [61755000555]

EYLEA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125387
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-01-16

NDC 61755-005-01 [61755000501]

EYLEA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125387
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-12-09

NDC 61755-005-54 [61755000554]

EYLEA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125387
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-12-09

Drug Details

Active Ingredients

Ingredient	Strength
AFLIBERCEPT	40 mg/mL

OpenFDA Data

• SPL SET ID: f96cfd69-da34-41ee-90a9-610a4655cd1c
• Manufacturer:
  • Regeneron Pharmaceuticals, Inc.
• UNII:
  • 15C2VL427D
• RxNorm Concept Unique ID - RxCUI:
  • 1232154
  • 1232159

Pharmacological Class

• Vascular Endothelial Growth Factor Inhibitor [EPC]
• Vascular Endothelial Growth Factor Inhibitors [MoA]