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

Additional Listing Data#

Finished product
Yes
Brand name base
ZEVASKYN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRADEMAGENE ZAMIKERACEL40 cm2/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4UU2O40RHU
Rxcui2713347, 2713352

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
b42496cd-a994-8ba1-597f-e507aa62246eProduct name520250116
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59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
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6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d1997359-a049-4781-b04b-084a7f3cb039Product name220200325
aa12d3c0-d2b4-4c50-9af0-cb08b230ec20Product name220200323
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a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
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d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
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26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
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61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
64b87b8d-6ae7-cef1-8fd2-34228b0cc1bcProduct name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84103-007-01ZEVASKYN4 in 1 BAGCELLULAR SHEET46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84103-007ZEVASKYN (PRADEMAGENE ZAMIKERACEL) CELLULAR SHEET [ABEONA THERAPEUTICS INC.]4Current NDC, 1 package rows20250521_f8782480-8782-4748-9764-b9ed60979d47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2713347prademagene zamikeracel 41.25 SQCM Cellular SheetPSNf8782480-8782-4748-9764-b9ed60979d476
2713352zevaskyn 41.25 SQCM Cellular SheetPSNf8782480-8782-4748-9764-b9ed60979d476
2713352prademagene zamikeracel 41.3 SQCM Medicated Patch [Zevaskyn]SBDf8782480-8782-4748-9764-b9ed60979d476
2713347prademagene zamikeracel 41.3 SQCM Medicated PatchSCDf8782480-8782-4748-9764-b9ed60979d476
2713347prademagene zamikeracel 41.25 SQCM Cellular SheetSYf8782480-8782-4748-9764-b9ed60979d476
2713352Zevaskyn 41.25 SQCM Cellular SheetSYf8782480-8782-4748-9764-b9ed60979d476

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84103-007-01841030007014 CELLULAR SHEET in 1 BAG (84103-007-01) 4 cellular sheet2025-06-15NoNoCurrent