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  5. NDC Package Code: 84103-007-01 Zevaskyn

NDC Package 84103-007-01 Zevaskyn

Prademagene Zamikeracel Cellular Sheet Topical - 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:
84103-007-01
Package Description:
4 CELLULAR SHEET in 1 BAG
Product Code:
84103-007
Proprietary Name:
Zevaskyn
Non-Proprietary Name:
Prademagene Zamikeracel
Substance Name:
Prademagene Zamikeracel
Usage Information:
ZEVASKYN is indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
11-Digit NDC Billing Format:
84103000701
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
4 EA
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Abeona Therapeutics Inc.
Dosage Form:
Cellular Sheet -
Administration Route(s):
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s):
PRADEMAGENE ZAMIKERACEL 40 cm2/1
Sample Package:
No
FDA Application Number:
BLA125807
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
06-15-2025
Listing Expiration Date:
12-31-2026
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 84103-007-01?

The NDC Packaged Code 84103-007-01 is assigned to a package of 4 cellular sheet in 1 bag of Zevaskyn, a human prescription drug labeled by Abeona Therapeutics Inc.. The product's dosage form is cellular sheet and is administered via topical form.This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package.

Is NDC 84103-007 included in the NDC Directory?

Yes, Zevaskyn with product code 84103-007 is active and included in the NDC Directory. The product was first marketed by Abeona Therapeutics Inc. on June 15, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 84103-007-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 4.

What is the 11-digit format for NDC 84103-007-01?

The 11-digit format is 84103000701. 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
5-3-284103-007-015-4-284103-0007-01