Izervay Injection
NDC Package 82829-002-99

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

Izervay (avacincaptad pegol) injection is iZERVAY™ is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This formulation utilizes a injection delivery system. Marketed by Astellas Pharma Us, Inc., this product is identified by NDC 82829-002 and is authorized under FDA application NDA217225.

Identification & Billing

NDC Package Code
82829-002-99
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / .35 mL in 1 VIAL, SINGLE-DOSE
Product Code
82829-002
11-Digit Billing Format
82829000299
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Izervay
Non-Proprietary Name
Avacincaptad Pegol
Substance Name
Avacincaptad Pegol Sodium
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravitreal - Administration within the vitreous body of the eye.
Active Ingredient(s)
AVACINCAPTAD PEGOL SODIUM 20 mg/mL
Pharmacologic Class
Usage Information
IZERVAY™ is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Regulatory & Marketing

Labeler Name
Astellas Pharma Us, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA217225
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-19-2023
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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 (82829-002). Click a package code to view its specific billing and regulatory data.

82829-002-01
1 VIAL, SINGLE-DOSE in 1 CARTON / .35 mL in 1 VIAL, SINGLE-DOSE

* 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 82829-002-99 identifies a specific commercial package of 1 vial, single-dose in 1 carton / .35 ml in 1 vial, single-dose of Izervay, a human prescription drug labeled by Astellas Pharma Us, Inc.. This injection is formulated for intravitreal use and contains avacincaptad pegol sodium 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 Astellas Pharma Us, Inc. on August 19, 2023. The current certification is valid through December 31, 2027.

How is this Astellas Pharma Us, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82829000299. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
82829-002-99
11-Digit CMS (5-4-2)
82829-0002-99

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