Zevaskyn Cellular Sheet
NDC Package 84103-007-01

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

Package Information

Zevaskyn (prademagene zamikeracel) cellular sheets is zEVASKYN is indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). This formulation utilizes a cellular sheet delivery system. Marketed by Abeona Therapeutics Inc., this product is identified by NDC 84103-007 and is authorized under FDA application BLA125807.

Identification & Billing

NDC Package Code
84103-007-01
Package Description
4 CELLULAR SHEET in 1 BAG
Product Code
84103-007
11-Digit Billing Format
84103000701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA

Clinical Specifications

Proprietary Name
Zevaskyn
Non-Proprietary Name
Prademagene Zamikeracel
Substance Name
Prademagene Zamikeracel
Dosage Form
Cellular Sheet -
Administration Route
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
Usage Information
ZEVASKYN is indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

Regulatory & Marketing

Labeler Name
Abeona Therapeutics Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125807
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-15-2025
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J3389
Source: OPPS
Topi adm prad zami per treat
HCPCS Dosage Per Therapeutic Dose
Units / Pkg 1

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 84103-007-01 identifies a specific commercial package of 4 cellular sheet in 1 bag of Zevaskyn, a human prescription drug labeled by Abeona Therapeutics Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package. This cellular sheet is formulated for topical use and contains prademagene zamikeracel 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 Abeona Therapeutics Inc. on June 15, 2025. The current certification is valid through December 31, 2027.

How is this Abeona Therapeutics Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84103000701. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 total billable units per package. 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)
84103-007-01
11-Digit CMS (5-4-2)
84103-0007-01

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