Prescription drug · BLA
Eylea HD (Aflibercept) NDC 61755-050
Aflibercept 8 mg/.07mL · Injection, Solution · Intravitreal · Regeneron Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61755-050-01 | 61755005001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-050-01) / .07 mL in 1 VIAL, SINGLE-DOSE (61755-050-00)Marketed from Aug 18, 2023 | |
| 61755-050-51 | 61755005051 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-050-51) / .07 mL in 1 VIAL, SINGLE-DOSE (61755-050-50)Marketed from Aug 18, 2023 |
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 HD
- Generic name (nonproprietary)
- aflibercept
- Active ingredients
- Aflibercept — 8 mg/.07mL
- Dosage form
- Injection, Solution
- Route
- Intravitreal
- Labeler
- Regeneron Pharmaceuticals, IncNDC labeler code 61755
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761355
- Marketing start
- Listing expires
- Other FDA classes
- Vascular Endothelial Growth Factor Inhibitors (Mechanism)
- Identifiers
- Product ID 61755-050_c6550964-b64e-42e9-a3b2-dd682b1dfbbcSPL ID c6550964-b64e-42e9-a3b2-dd682b1dfbbcSPL set ID 86d8848b-111b-4da9-8957-7cccef1b8f66RxCUI 2645305, 2645308UNII 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 codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N461755005001followed by a unit qualifier and the quantityPackage 61755-0050-01. 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 HD is indicated for the treatment of: EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Diabetic Retinopathy (DR) ( 1.3 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.4 ) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (nAMD) 1.2 Diabetic Macular Edema (DME) 1.3 Diabetic Retinopathy (DR) 1.4 Macular Edema Following Retinal Vein Occlusion (RVO)
Excerpt only. Read the full label for complete information.
About NDC 61755-050
- What is NDC 61755-050?
- 61755-050 is the product NDC for Eylea HD (aflibercept), Aflibercept 8 mg/.07mL injection, solution, listed with the FDA by Regeneron Pharmaceuticals, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eylea HD (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 HD?
- 1 other product NDC are listed under this name. See all Eylea HD NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eylea HD products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eylea HDaflibercept | Aflibercept 8 mg/.07mL | Injection, SolutionIntravitreal | Regeneron Pharmaceuticals, Inc | 61755-051 | 61755-0051-0161755-0051-51 |
Other NDCs under BLA 761355
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Eylea HDaflibercept | Aflibercept 8 mg/.07mL | Injection, SolutionIntravitreal | Regeneron Pharmaceuticals, Inc | 61755-051 |