Pavblu Injection, Solution
NDC Package 55513-065-96

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Pavblu (aflibercept-ayyh) injection is aflibercept is used to treat certain serious eye conditions (such as wet age-related macular degeneration, diabetic retinopathy/macular edema, macular edema following retinal vein occlusion). This formulation utilizes a injection, solution delivery system. Marketed by Amgen, Inc, this product is identified by NDC 55513-065 and is authorized under FDA application BLA761298.

Identification & Billing

NDC Package Code
55513-065-96
Package Description
1 VIAL in 1 CARTON / .05 mL in 1 VIAL
Product Code
55513-065
11-Digit Billing Format
55513006596
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pavblu
Non-Proprietary Name
Aflibercept-ayyh
Substance Name
Aflibercept
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravitreal - Administration within the vitreous body of the eye.
Active Ingredient(s)
AFLIBERCEPT 2 mg/.05mL
Pharmacologic Class
Usage Information
Aflibercept is used to treat certain serious eye conditions (such as wet age-related macular degeneration, diabetic retinopathy/macular edema, macular edema following retinal vein occlusion). This medication can help preserve vision and prevent blindness. Aflibercept belongs to a class of drugs known as growth factor inhibitors. It works by slowing the growth of abnormal new blood vessels in the eye and decreasing leakage from these blood vessels.

Regulatory & Marketing

Labeler Name
Amgen, Inc
Product Type
Human Prescription Drug
FDA Application #
BLA761298
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-28-2024
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55513-065). Click a package code to view its specific billing and regulatory data.

55513-065-01
1 VIAL in 1 CARTON / .05 mL in 1 VIAL

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55513-065-96 identifies a specific commercial package of 1 vial in 1 carton / .05 ml in 1 vial of Pavblu, a human prescription drug labeled by Amgen, Inc. This injection, solution is formulated for intravitreal use and contains aflibercept as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amgen, Inc on October 28, 2024. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Aflibercept is used to treat certain serious eye conditions (such as wet age-related macular degeneration, diabetic retinopathy/macular edema, macular edema following retinal vein occlusion). This medication can help preserve vision and prevent blindness. Aflibercept belongs to a class of drugs known as growth factor inhibitors. It works by slowing the growth of abnormal new blood vessels in the eye and decreasing leakage from these blood vessels.

How is this Amgen, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55513006596. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
55513-065-96
11-Digit CMS (5-4-2)
55513-0065-96

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.