Prescription drug · BLA
Zevaskyn (Prademagene zamikeracel) NDC 84103-007
Prademagene zamikeracel 40 cm2/1 · Cellular sheet · Topical · Abeona Therapeutics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84103-007-01 | 84103000701 | 4 CELLULAR SHEET in 1 BAG (84103-007-01)Marketed from Jun 15, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Zevaskyn
- Generic name (nonproprietary)
- prademagene zamikeracel
- Active ingredients
- Prademagene zamikeracel — 40 cm2/1
- Dosage form
- Cellular sheet
- Route
- Topical
- Labeler
- Abeona Therapeutics Inc.NDC labeler code 84103
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125807
- Marketing start
- Listing expires
- Identifiers
- Product ID 84103-007_08bab4ea-47c5-4f67-8c6e-fdbfd6330655SPL ID 08bab4ea-47c5-4f67-8c6e-fdbfd6330655SPL set ID f8782480-8782-4748-9764-b9ed60979d47RxCUI 2713347, 2713352UNII 4UU2O40RHU
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N484103000701followed by a unit qualifier and the quantityPackage 84103-0007-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ZEVASKYN is indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). ZEVASKYN is an autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 84103-007
- What is NDC 84103-007?
- 84103-007 is the product NDC for Zevaskyn (prademagene zamikeracel), Prademagene zamikeracel 40 cm2/1 cellular sheet, listed with the FDA by Abeona Therapeutics Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zevaskyn (Prademagene zamikeracel).
- What is the active ingredient?
- Prademagene zamikeracel.
- Who is the labeler?
- Abeona Therapeutics Inc., NDC labeler code 84103. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zevaskyn?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.