Prescription drug · BLA
Eylea (Aflibercept) NDC 61755-005
Aflibercept 40 mg/mL · Injection, Solution · Intravitreal · Regeneron Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61755-005-01 | 61755000501 | 1 SYRINGE, GLASS in 1 CARTON (61755-005-01) / .05 mL in 1 SYRINGE, GLASSMarketed from Dec 9, 2019 | |
| 61755-005-02 | 61755000502 | 1 VIAL, SINGLE-USE in 1 CARTON (61755-005-02) / .05 mL in 1 VIAL, SINGLE-USEMarketed from Nov 21, 2011 | |
| 61755-005-54 | 61755000554 | 1 SYRINGE, GLASS in 1 CARTON (61755-005-54) / .05 mL in 1 SYRINGE, GLASSMarketed from Dec 9, 2019 | |
| 61755-005-55 | 61755000555 | 1 VIAL, SINGLE-USE in 1 CARTON (61755-005-55) / .05 mL in 1 VIAL, SINGLE-USEMarketed from Jan 16, 2014 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Eylea
- Generic name (nonproprietary)
- aflibercept
- Active ingredients
- Aflibercept — 40 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravitreal
- Labeler
- Regeneron Pharmaceuticals, Inc.NDC labeler code 61755
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125387
- Marketing start
- Listing expires
- Other FDA classes
- Vascular Endothelial Growth Factor Inhibitors (Mechanism)
- Identifiers
- Product ID 61755-005_9e18f393-aea5-48ef-8ac9-7d523f0badc0SPL ID 9e18f393-aea5-48ef-8ac9-7d523f0badc0SPL set ID f96cfd69-da34-41ee-90a9-610a4655cd1cRxCUI 1232154, 1232159, 2693564, 2693567UNII 15C2VL427D
- Pharmacologic class
- Vascular Endothelial Growth Factor Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeMed-Code curated
J0178 — Injection, aflibercept, 1 mg
Billing unit: 1 mg. Units on the claim = dose given ÷ 1 mg.
EYLEA HD has its own HCPCS code.
- Administration
Intravitreal injection procedure (CPT 67028)
The intravitreal injection is reported as a separate procedure from the drug supplied.
- NDC on a medical claim
N461755000501followed by a unit qualifier and the quantityPackage 61755-0005-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
EYLEA is indicated for the treatment of: EYLEA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.2 ) Diabetic Macular Edema (DME) ( 1.3 ) Diabetic Retinopathy (DR) ( 1.4 ) Retinopathy of Prematurity (ROP) ( 1.5 ) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 Macular Edema Following Retinal Vein Occlusion (RVO) 1.3 Diabetic Macular Edema (DME) 1.4 Diabetic Retinopathy (DR) 1.5 Retinopathy of Prematurity (ROP)
Excerpt only. Read the full label for complete information.
About NDC 61755-005
- What is NDC 61755-005?
- 61755-005 is the product NDC for Eylea (aflibercept), Aflibercept 40 mg/mL injection, solution, listed with the FDA by Regeneron Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eylea (Aflibercept).
- What is the active ingredient?
- Aflibercept.
- Who is the labeler?
- Regeneron Pharmaceuticals, Inc., NDC labeler code 61755. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eylea?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Yes: J0178, Injection, aflibercept, 1 mg. See Billing references above.