Home NDC 84103-007 ZEVASKYN
Product NDC 84103-007
11-digit product format 841030007
Labeler code 84103
Product ID 84103-007_ca62dd79-807c-4ba8-9c77-028277200dd6
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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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 2026-06-01
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