Home NDC 84103-007 ZEVASKYN
Product NDC 84103-007
11-digit product format 841030007
Labeler code 84103
Product ID 84103-007_08bab4ea-47c5-4f67-8c6e-fdbfd6330655
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name prademagene zamikeracel
Dosage form CELLULAR SHEET
Route TOPICAL
Labeler Abeona Therapeutics Inc.
Application BLA125807
Marketing category BLA
Marketing start 2025-06-15
Substance PRADEMAGENE ZAMIKERACEL
Active strength 40 cm2/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ZEVASKYN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRADEMAGENE ZAMIKERACEL 40 cm2/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4UU2O40RHU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2713347 Internal RxNorm lookup 2713352 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84103-007-01 ZEVASKYN 4 in 1 BAG CELLULAR SHEET 4 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84103-007 ZEVASKYN (PRADEMAGENE ZAMIKERACEL) CELLULAR SHEET [ABEONA THERAPEUTICS INC.] 4 Current NDC, 1 package rows 20250521_f8782480-8782-4748-9764-b9ed60979d47.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125807 zevaskyn Prademagene zamikeracel 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84103-007-01 84103000701 4 CELLULAR SHEET in 1 BAG (84103-007-01) 4 cellular sheet 2025-06-15 No No Current