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  5. NDC Package Code: 82829-002-99 Izervay

NDC Package 82829-002-99 Izervay

Avacincaptad Pegol Injection Intravitreal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
82829-002-99
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / .35 mL in 1 VIAL, SINGLE-DOSE (82829-002-01)
Product Code:
82829-002
Proprietary Name:
Izervay
Non-Proprietary Name:
Avacincaptad Pegol
Substance Name:
Avacincaptad Pegol Sodium
Usage Information:
IZERVAY™ is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
11-Digit NDC Billing Format:
82829000299
NDC to RxNorm Crosswalk:
  • RxCUI: 2645112 - avacincapted pegol 2 MG in 0.1 ML Injection
  • RxCUI: 2645112 - 0.1 ML avacincaptad pegol 20 MG/ML Injection
  • RxCUI: 2645112 - avacincapted pegol 2 MG per 0.1 ML Injection
  • RxCUI: 2645118 - izervay 2 MG in 0.1 ML Injection
  • RxCUI: 2645118 - 0.1 ML avacincaptad pegol 20 MG/ML Injection [Izervay]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Astellas Pharma Us, Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intravitreal - Administration within the vitreous body of the eye.
    • Active Ingredient(s):
  • AVACINCAPTAD PEGOL SODIUM 20 mg/mL
    • Pharmacologic Class(es):
  • Complement Inhibitor - [EPC] (Established Pharmacologic Class)
  • Complement Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA217225
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-19-2023
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 82829-002-99?

    The NDC Packaged Code 82829-002-99 is assigned to a package of 1 vial, single-dose in 1 carton / .35 ml in 1 vial, single-dose (82829-002-01) of Izervay, a human prescription drug labeled by Astellas Pharma Us, Inc.. The product's dosage form is injection and is administered via intravitreal form.

    Is NDC 82829-002 included in the NDC Directory?

    Yes, Izervay with product code 82829-002 is active and included in the NDC Directory. The product was first marketed by Astellas Pharma Us, Inc. on August 19, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 82829-002-99?

    The 11-digit format is 82829000299. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-282829-002-995-4-282829-0002-99