Prescription drug · BLA
Pavblu (Aflibercept-ayyh) NDC 55513-056
Aflibercept 2 mg/.05mL · Injection, Solution · Intravitreal · Amgen, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-056-01 | 5551300560155513005601 | 1 SYRINGE in 1 CARTON (55513-056-01) / .05 mL in 1 SYRINGEMarketed from Oct 28, 2024 | |
| 55513-056-96 | 5551300569655513005696 | 1 SYRINGE in 1 CARTON (55513-056-96) / .05 mL in 1 SYRINGEMarketed from Oct 28, 2024 |
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)
- Pavblu
- Generic name (nonproprietary)
- aflibercept-ayyh
- Active ingredients
- Aflibercept — 2 mg/.05mL
- Dosage form
- Injection, Solution
- Route
- Intravitreal
- Labeler
- Amgen, IncNDC labeler code 55513
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761298
- Marketing start
- Listing expires
- Other FDA classes
- Vascular Endothelial Growth Factor Inhibitors (Mechanism)
- Identifiers
- Product ID 55513-056_04e11a27-3d29-4776-bd2f-139a952423feSPL ID 04e11a27-3d29-4776-bd2f-139a952423feSPL set ID c61062f3-80ec-4a20-8c28-46e468592a06RxCUI 2696260, 2696267, 2696270, 2696274UNII 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 and aflibercept biosimilars have their own HCPCS codes.
- Administration
Intravitreal injection procedure (CPT 67028)
The intravitreal injection is reported as a separate procedure from the drug supplied.
- NDC on a medical claim
N455513005601followed by a unit qualifier and the quantityPackage 55513-0056-01. 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)
PAVBLU is indicated for the treatment of: PAVBLU 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 ) 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)
Excerpt only. Read the full label for complete information.
About NDC 55513-056
- What is NDC 55513-056?
- 55513-056 is the product NDC for Pavblu (aflibercept-ayyh), Aflibercept 2 mg/.05mL injection, solution, listed with the FDA by Amgen, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pavblu (Aflibercept-ayyh).
- What is the active ingredient?
- Aflibercept.
- Who is the labeler?
- Amgen, Inc, NDC labeler code 55513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pavblu?
- 1 other product NDC are listed under this name. See all Pavblu NDCs.
- Is there a related HCPCS / J-code?
- Yes: J0178, Injection, aflibercept, 1 mg. See Billing references above.
Related NDCs: other Pavblu products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pavbluaflibercept-ayyh | Aflibercept 2 mg/.05mL | Injection, SolutionIntravitreal | Amgen, Inc | 55513-065 | 55513-0065-0155513-0065-96 |
Other NDCs under BLA 761298
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 |
|---|---|---|---|---|
| Pavbluaflibercept-ayyh | Aflibercept 2 mg/.05mL | Injection, SolutionIntravitreal | Amgen, Inc | 55513-065 |