FDA.reportPublic FDA data

prademagene zamikeracel 41.3 SQCM Medicated Patch

RxCUI
2713347
RxNorm name
prademagene zamikeracel 41.3 SQCM Medicated Patch
Display name
prademagene zamikeracel 41.3 SQCM Medicated Patch
Full name
prademagene zamikeracel 41.3 SQCM Medicated Patch
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:28

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125807zevaskynPrademagene zamikeracel351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZEVASKYNPRADEMAGENE ZAMIKERACELAbeona Therapeutics Inc.f8782480-8782-4748-9764-b9ed60979d472026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 2713347

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f8782480-8782-4748-9764-b9ed60979d47prademagene zamikeracel 41.25 SQCM Cellular Sheet [PSN] · prademagene zamikeracel 41.3 SQCM Medicated Patch [SCD] · prademagene zamikeracel 41.25 SQCM Cellular Sheet [SY]36These highlights do not include all the information needed to use ZEVASKYN ® safely and effectively. See full prescribing information for ZEVASKYN . ZEVASKYN ( prademagene zamikeracel ) , gene - modified cellular sheet s , for topical use Initial U.S. Approval: 20 2520260331