Home NDC 72493-106 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215793-001 ZUSDURI MITOMYCIN 40MG/VIAL POWDER / INTRAVESICAL RLD, RS 2025-06-12
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215793-001 10039832 2031-01-20 U-4256 2025-09-03 N215793-001 12440568 2031-01-20 U-4256 2025-10-21 N215793-001 9040074 2031-01-20 U-4256 Drug product 2025-09-03 N215793-001 9950069 2031-01-20 U-4256 Drug product 2025-09-03
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215793-001 NP 2028-06-12
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N215793-001 ZUSDURI 40MG/VIAL POWDER / INTRAVESICAL RLD, RS 2025-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215793-001 ZUSDURI 40MG/VIAL POWDER / INTRAVESICAL RLD, RS 2025-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215793-001 ZUSDURI 40MG/VIAL POWDER / INTRAVESICAL RLD, RS 2025-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215793-001 ZUSDURI 40MG/VIAL POWDER / INTRAVESICAL RLD, RS 2025-06-12 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215793-001 ZUSDURI 40MG/VIAL POWDER / INTRAVESICAL RLD, RS 2025-06-12 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N215793-001 10039832 2031-01-20 U-4256 2025-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215793-001 12440568 2031-01-20 U-4256 2025-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215793-001 9040074 2031-01-20 U-4256 Drug product 2025-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215793-001 9950069 2031-01-20 U-4256 Drug product 2025-09-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215793-001 10039832 2031-01-20 U-4256 2025-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215793-001 12440568 2031-01-20 U-4256 2025-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215793-001 9040074 2031-01-20 U-4256 Drug product 2025-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215793-001 9950069 2031-01-20 U-4256 Drug product 2025-09-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215793-001 10039832 2031-01-20 U-4256 2025-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215793-001 12440568 2031-01-20 U-4256 2025-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215793-001 9040074 2031-01-20 U-4256 Drug product 2025-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215793-001 9950069 2031-01-20 U-4256 Drug product 2025-09-03 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215793-001 10039832 2031-01-20 U-4256 2025-09-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215793-001 12440568 2031-01-20 U-4256 2025-10-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215793-001 9040074 2031-01-20 U-4256 Drug product 2025-09-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215793-001 9950069 2031-01-20 U-4256 Drug product 2025-09-03 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 N215793-001 NP 2028-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215793-001 NP 2028-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215793-001 NP 2028-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215793-001 NP 2028-06-12 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215793-001 NP 2028-06-12 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base ZUSDURI
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2719766 Internal RxNorm lookup 2719771 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 72493-104-40 ZUSDURI 1 in 1 VIAL, SINGLE-DOSE POWDER, FOR SOLUTION 2 40 mg 2 72493-106-03 ZUSDURI 1 in 1 CARTON KIT 1 2
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72493-104-40 72493010440 1 in 1 VIAL, SINGLE-DOSE Historical 72493-106-03 72493010603 1 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 kit 2025-07-01 No No Current