ZEVASKYN

UNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAbeona Therapeutics Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8410300701
4 CELLULAR SHEET in 1 BAG (84103-007-01)

Annotations

UNII (FDA Substance ID)

4UU2O40RHU

PRADEMAGENE ZAMIKERACEL

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4UU2O40RHU",
    "rxcui": null,
    "inchikey": null,
    "display_name": "PRADEMAGENE ZAMIKERACEL",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "f8782480-8782-4748-9764-b9ed60979d47": {
      "match": "brand_token",
      "title": "ZEVASKYN (PRADEMAGENE ZAMIKERACEL) CELLULAR SHEET [ABEONA THERAPEUTICS INC.]",
      "spl_version": "6",
      "published_date": "2026-03-31"
    }
  },
  "productid": "84103-007_ca62dd79-807c-4ba8-9c77-028277200dd6",
  "productndc": "84103-007",
  "dosage_form": "CELLULAR SHEET",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRADEMAGENE ZAMIKERACEL",
  "proprietary_name": "ZEVASKYN",
  "active_ingred_unit": "cm2/1",
  "application_number": "BLA125807",
  "marketing_category": "BLA",
  "nonproprietary_name": "prademagene zamikeracel",
  "start_marketing_date": "20250615",
  "active_numerator_strength": "40"
}

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