ZUSDURI

Product NDC
72493-106
11-digit product format
724930106
Labeler code
72493
Product ID
72493-106_5437ba4d-fe9b-4dde-b9b9-97a1389fd682
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mitomycin
Dosage form
KIT
Labeler
UroGen Pharma, Inc
Application
NDA215793
Marketing category
NDA
Marketing start
2025-07-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZUSDURI
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui2719766, 2719771

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
61a18a7f-d50a-4423-aa08-6a8f710ed5daProduct name720250722
1f4d6d8c-234a-4bf6-b123-695584719ba0Product name120200728

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72493-104-40ZUSDURI1 in 1 VIAL, SINGLE-DOSEPOWDER, FOR SOLUTION240 mg2
72493-106-03ZUSDURI1 in 1 CARTONKIT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72493-106-03EA - Each72493-1069fa7ecf6-f6f6-43ad-bd62-93208bfe8bac12025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2719766mitoMYcin 40 MG Powder for Intravesical SolutionPSN8dc68793-bca8-4e3d-b672-622961b582552
2719771Zusduri 40 MG Powder for Intravesical SolutionPSN8dc68793-bca8-4e3d-b672-622961b582552
2719771mitomycin 40 MG Powder for Intravesical Solution [Zusduri]SBD8dc68793-bca8-4e3d-b672-622961b582552
2719766mitomycin 40 MG Powder for Intravesical SolutionSCD8dc68793-bca8-4e3d-b672-622961b582552
2719771Zusduri 40 MG Powder for Intravesical SolutionSY8dc68793-bca8-4e3d-b672-622961b582552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72493-104-40724930104401 in 1 VIAL, SINGLE-DOSEHistorical
72493-106-03724930106031 KIT in 1 CARTON (72493-106-03) * 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72493-104-40) * 60 mL in 1 VIAL, SINGLE-DOSE (72493-105-60) 1 kit2025-07-01NoNoHistorical