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ZUSDURI Mitomycin Kit — NDC 72493-106-03 (Billing 72493-0106-03)

by UroGen Pharma, Inc · 1 KIT in 1 CARTON * 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE * 60 mL in 1 VIAL, SINGLE-DOSE

This is a package of ZUSDURI Mitomycin Kit from UroGen Pharma, Inc, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 72493-0106-03
🏷️ FDA NDC (as labeled) 72493-106-03 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72493-106-03
Product NDC 72493-106
11-digit billing NDC 72493010603
NCPDP billing unit EA — each (per item)
RxCUI 2719766, 2719771
UPC 0372493105600
Application # NDA215793
SPL Set ID 8dc68793-bca8-4e3d-b672-622961b58255
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-01
Dosage form KIT

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21200050006460
GCN Seq No 087867
GCN 57894
HICL code 003917
Ingredient (HICL) Mitomycin
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1D
Therapeutic class — specific (HIC3) Antibiotic Antineoplastics
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name ZUSDURI SINGLE-DOSE KT(40MGX2)
FDB brand name Zusduri
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087867
  • GCN: 57894
  • GPI-14 (Medi-Span): 21200050006460
  • HICL (First Databank): 003917
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2719766
Why two NDCs? The FDA registers this code as 72493-106-03 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72493-0106-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Alkylating Drug class.

Pharmacologic class Alkylating Drug
Drug family (ATC) Other cytotoxic antibiotics
How it works Alkylating Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ZUSDURI SINGLE-DOSE KT(40MGX2) Ingredient Mitomycin
📖 What it is MedlinePlus · NLM

Mitomycin is used for the treatment of a certain type of bladder cancer. Mitomycin is in a class of medications called anticancer antibiotics. It works by slowing or stopping the growth of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • The injection form, sold as Mitomycin or Mutamycin, is used with other chemotherapy drugs for stomach or pancreatic cancer that has spread. It can also be used for palliative care...
  • The injection goes into a vein through an IV catheter. A healthcare professional with chemotherapy experience gives it. Treatments are spaced several weeks apart, once your blood c...
  • The most common is low blood counts, which is why you will have regular blood tests. Nausea, vomiting, and tiredness can also occur. Your team will adjust the plan if your counts d...
  • Call for fever, chills, or other signs of infection. Also call for unusual bleeding or bruising, much less urine, or swelling. Pain, redness, or skin damage where the IV was placed...
📖 Read our full Mitomycin guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9282 $274.342 / J9282 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)72493-106-03
11-digit billing NDC72493-0106-03
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9282
Descriptor1 MG
Billing units / pkg80 units
How the units are derivedThis package is 1; the HCPCS unit is 1 MG, so one package = 80 billing units.
Medicare Part B spend (2026 (Q1))$14,537,386 · 747 claims · $19,461.02 per claim (all NDCs under J9282)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72493-0106-03 You're viewing this Main listing 1 KIT in 1 CARTON * 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE * 60 mL in 1 VIAL, SINGLE-DOSE 2025-07-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zusdurithis 72493-0106-03 UroGen 1 kit — — FDA listed —
Mitosol 49771-0002-03 Mobius 1 kit — — FDA listed —
Jelmyto 72493-0103-03 UroGen 1 kit — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
First FDA approval
Jun 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 12, 2025 RLD RS ⏳ ~4.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10039832 — method of use (U-4256)
US 9950069 — method of use (U-4256)
US 9040074 — method of use (U-4256)
US 12440568 — method of use (U-4256)
Exclusivity NP
2025 2027 2029 2031
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (4)
PatentTypeUse codeExpires
US 10039832 ↗ Method of use U-4256 Jan 20, 2031
US 9950069 ↗ Method of use U-4256 Jan 20, 2031
US 9040074 ↗ Method of use U-4256 Jan 20, 2031
US 12440568 ↗ Method of use U-4256 Jan 20, 2031
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductJun 12, 2028
Common questions
Is there a generic version of ZUSDURI SINGLE-DOSE KT(40MGX2)?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ZUSDURI SINGLE-DOSE KT(40MGX2). Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2031 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerUroGen Pharma, Inc
Application holderUROGEN PHARMA LTD
FDA applicationNDA215793 (NDA)
Labeler code72493
First marketedJul 2025
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 words ▾

1 INDICATIONS AND USAGE ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Administer ZUSDURI by intravesical instillation only. Do not administer by pyelocalyceal instillation or by any other route. ( 2.1 ) The recommended dose of ZUSDURI is 75 mg (56 mL) instilled once weekly for six weeks. ( 2.2 )

2.1Important Administration Instructions Administer ZUSDURI by intravesical instillation only. Do not administer by pyelocalyceal instillation or by any other route.

2.2Recommended Dose The recommended dose of ZUSDURI is 75 mg (56 mL) instilled once weekly for six weeks into the bladder via a urinary catheter. [see Dosage and Administration (2.4) ]

2.3Preparation Instructions See the Instructions for Pharmacy enclosed in the carton for complete information on preparation. ZUSDURI must be reconstituted with sterile hydrogel under chilled conditions. Reconstituted ZUSDURI has reverse thermal properties with a gelation point of approximately 19°C (66°F) and will appear as a viscous liquid under chilled conditions and a semisolid gel at room temperature.

Storage Instructions for Reconstituted ZUSDURI: Instill reconstituted ZUSDURI as soon as possible. If not used immediately, store reconstituted ZUSDURI: under refrigeration at 2℃ to 8℃ (36°F to 46°F) for up to 7 days; or under refrigeration at 2℃ to 8℃ (36°F to 46°F) for up to 6 days followed by no more than 24 hours at room temperature, 20°C to 25°C (68°F to 77°F). Discard 7 days after reconstitution.

Protect from light. Avoid excessive heat over 40°C (104°F). ZUSDURI is a hazardous drug.

Follow applicable special handling and disposal procedures. 1

2.4Bladder Instillation of ZUSDURI See the Instructions for Administration enclosed in the carton for complete information on bladder instillation. ZUSDURI must be chilled at -3°C to 5°C (27°F to 41°F) to convert to a viscous liquid prior to instillation. When instilling ZUSDURI, each syringe must be emptied within thirty (30) seconds to avoid gelation.

Instillation of ZUSDURI requires syringes and a urinary catheter with fixed Luer Lock connectors. Advise patients that ZUSDURI may discolor urine to a violet to blue color following the instillation procedure. Advise patients for at least 24 hours post-instillation to avoid urine contact with skin, to void urine sitting on a toilet, to wash hands and genital area with water and soap after each urination, and to flush the toilet several times after use.

💊 Dosage Forms and Strengths 104 words ▾

3 DOSAGE FORMS AND STRENGTHS For intravesical solution: A kit containing the following: Two 40 mg (each) single-dose vials of sterile, lyophilized, grey to greyish-purple, cake or powder of mitomycin for intravesical solution. One single-dose vial of 60 mL of sterile, clear, colorless gel with or without bubbles at room temperature or clear, colorless liquid at 2°C to 8°C (36°F to 46°F), to be used as a vehicle for reconstitution. For intravesical solution: A kit containing the following: Two 40 mg (each) single-dose vials of mitomycin for intravesical solution.

( 3 ) One vial of 60 mL sterile hydrogel for reconstitution. ( 3 )

⛔ Contraindications 50 words ▾

4 CONTRAINDICATIONS ZUSDURI is contraindicated in patients with: Perforation of the bladder [see Warnings and Precautions (5.1) ], Prior hypersensitivity reactions to mitomycin or any component of the product. Perforation of the bladder, ( 4 ) Prior hypersensitivity reaction to mitomycin or any component of the product. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Risks in Patients with Perforated Bladder : Evaluate the bladder before the intravesical instillation of ZUSDURI. Do not administer to patients with a perforated bladder or in whom the integrity of the bladder mucosa has been compromised. ( 4 , 5.1 ). Embryo-Fetal Toxicity : Can cause fetal harm. Advise of potential risk to a fetus and to use effective contraception. ( 5.2 , 8.1 , 8.3 )

5.1Risks in Patients with Perforated Bladder ZUSDURI may lead to systemic exposure to mitomycin and severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised. Evaluate the bladder before the intravesical instillation of ZUSDURI and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored [see Contraindications (4) ].

5.2Embryo-Fetal Toxicity Based on findings in animals and mechanism of action, ZUSDURI can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of mitomycin resulted in teratogenicity. Advise females of reproductive potential to use effective contraception during treatment with ZUSDURI and for 6 months following the last dose.

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZUSDURI and for 3 months following the last dose [see Use in Specific Populations (8.1 , 8.3) and Clinical Pharmacology (12.1) ].

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most common (≥ 10%) adverse reactions, including laboratory abnormalities, that occurred in patients were increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UroGen Pharma at 1-855-987-6436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. The safety of ZUSDURI was evaluated in ENVISION, a single-arm, multicenter study in 240 patients with recurrent LG-IR-NMIBC [see Clinical Studies (14) ]. Patients received 75 mg ZUSDURI instilled once a week for 6 consecutive weeks.

The median number of doses of ZUSDURI administered to patients was 6 (range 1-6) doses and 228 patients (95%) received all six scheduled doses. Serious adverse reactions occurred in 12% of patients who received ZUSDURI, including urinary retention (0.8%) and urethral stenosis (0.4%). A fatal adverse reaction of cardiac failure occurred in 1 patient (0.4%) receiving ZUSDURI.

Permanent discontinuation of ZUSDURI due to an adverse reaction occurred in 2.9% of patients, including 1.7% who discontinued due to a renal or urinary disorder. Dosage interruption of ZUSDURI due to adverse reactions occurred in 10% of patients. Adverse reactions (≥ 2%) which required dosage interruption were urinary tract infection (2.5%) and dysuria (2.5%).

The most common (≥ 10%) adverse reactions, including laboratory abnormalities, that occurred in patients were increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. Table 1 summarizes the adverse reactions in ENVISION. Table 1: Adverse Reactions (≥ 10% All Grades Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. ) in Patients Who Received ZUSDURI in ENVISION Adverse Reaction ZUSDURI N = 240 All Grades (%) Grade 3 or 4 Only includes Grade 3 adverse reactions (%) Renal and urinary disorders Dysuria 23

0.4Hematuria Includes multiple related terms 10 0 Infections and infestations Urinary tract infection 12

0.8Clinically relevant adverse reactions occurring in < 10% of patients receiving ZUSDURI in ENVISION included increased urinary frequency, fatigue, urinary incontinence, urinary retention, urethral stenosis, genital pain, urinary urgency, genital edema, genital pruritus, genital rash, urethritis, acute kidney injury, balanoposthitis, and nocturia. Table 2 summarizes laboratory abnormalities in ENVISION. Table 2: Laboratory Abnormalities (≥ 10% All Grades Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. ) That Worsened From Baseline in Patients Who Received ZUSDURI in ENVISION Laboratory Abnormality ZUSDURI The denominator used to calculate the rate varied from 227 to 238 based on the number of patients with a baseline value and at least one post-treatment value All Grades (%) Grade 3 or 4 Only includes Grade 3 laboratory abnormalities (%) Hematology Hemoglobin Decreased 17

0.8 Eosinophils Increased 15 0 Lymphocytes Decreased 14

0.4 Neutrophils Decreased 10

0.4 Chemistry Creatinine Increased 29

1.3 Potassium Increased 26

2.2 Aspartate Aminotransferase (AST) Increased 15

0.4Alanine Aminotransferase (ALT) Increased 15 0.4

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on findings in animals and mechanism of action, ZUSDURI can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on ZUSDURI use in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of mitomycin resulted in teratogenicity (see Data ) .

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively.

Data Animal Data Teratological changes have been noted with mitomycin in animal studies.

8.2Lactation Risk Summary There are no data on the presence of mitomycin in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ZUSDURI and for 1 week following the last dose.

8.3Females and Males of Reproductive Potential ZUSDURI can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating ZUSDURI. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with ZUSDURI and for 6 months following the last dose.

Males Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZUSDURI and for 3 months following the last dose.

8.4Pediatric Use Safety and efficacy in pediatric patients have not been established.

8.5Geriatric Use Of the 240 patients receiving ZUSDURI in the ENVISION study, 162 (68%) were 65 years of age and older and 89 (37%) were 75 years of age and older. No significant overall differences in safety or efficacy were observed in patients 65 years of age and older, and in patients 75 years of age and older, compared to younger patients.

8.6Renal Impairment Avoid use of ZUSDURI in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min). A higher incidence of hematuria and urinary tract infections was observed in patients with moderate renal impairment (eGFR 30 to <60 mL/min). Monitor patients with moderate renal impairment for increased adverse reactions.

No dosage adjustments are recommended in patients with mild (eGFR 60 to <90 mL/min) or moderate renal impairment.

🤰 Pregnancy 127 words ▾

8.1Pregnancy Risk Summary Based on findings in animals and mechanism of action, ZUSDURI can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on ZUSDURI use in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of mitomycin resulted in teratogenicity (see Data ) .

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively.

Data Animal Data Teratological changes have been noted with mitomycin in animal studies.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and efficacy in pediatric patients have not been established.

🧓 Geriatric Use 63 words ▾

8.5Geriatric Use Of the 240 patients receiving ZUSDURI in the ENVISION study, 162 (68%) were 65 years of age and older and 89 (37%) were 75 years of age and older. No significant overall differences in safety or efficacy were observed in patients 65 years of age and older, and in patients 75 years of age and older, compared to younger patients.

🧬 Clinical Pharmacology 208 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Mitomycin inhibits the synthesis of deoxyribonucleic acid (DNA). The guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking. At high concentrations of the drug, cellular RNA and protein synthesis are also suppressed.

12.2Pharmacodynamics Mitomycin exposure-response relationships and time course of pharmacodynamic response are unknown.

12.3Pharmacokinetics The systemic exposure of mitomycin following instillation of 75 mg of mitomycin as ZUSDURI into the bladder was evaluated pre-instillation and hourly for up to six hours post-instillation in six patients. Mitomycin mean (range) maximum concentration (Cmax) is 2.3 ng/mL (0.2 to 8.9 ng/mL), which is less than 1% of the expected Cmax after intravenous administration. Metabolism Mitomycin is metabolized primarily in the liver, but metabolism occurs in other tissues as well.

It is believed that the rate of clearance is inversely proportional to the maximal serum concentration because of saturation of the degradative pathways. Excretion Following instillation into the bladder, ZUSDURI forms a semisolid gel which dissolves in the urine. Patients reported visible gel in urine for up to 24 hours (median 5 hours) after instillation.

Mitomycin is excreted unchanged in the urine. Systemically absorbed mitomycin is rapidly cleared from the serum and approximately 10% is excreted unchanged in the urine.

🧬 Mechanism of Action 38 words ▾

12.1Mechanism of Action Mitomycin inhibits the synthesis of deoxyribonucleic acid (DNA). The guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking. At high concentrations of the drug, cellular RNA and protein synthesis are also suppressed.

📦 How Supplied / Storage and Handling 134 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ZUSDURI is available in a kit (NDC 72493-106-03) containing the following: Two 40 mg (each) single-dose vials of mitomycin for intravesical solution supplied as a sterile, lyophilized, grey to greyish-purple, cake or powder. (NDC 72493-104-40) One single-dose vial of 60 mL sterile hydrogel supplied as a sterile, clear, colorless gel with or without bubbles at room temperature or clear, colorless liquid at 2°C to 8°C (36°F to 46°F), to be used as a vehicle for reconstitution.

(NDC 72493-105-60) Storage and Handling Store ZUSDURI at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Avoid excessive heat over 40°C (104°F). Protect from light.

ZUSDURI is a hazardous drug. Follow applicable special handling and disposal procedures . 1

📦 Storage and Handling 49 words ▾

Storage and Handling Store ZUSDURI at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Avoid excessive heat over 40°C (104°F). Protect from light. ZUSDURI is a hazardous drug. Follow applicable special handling and disposal procedures . 1

📋 Description 218 words ▾

11 DESCRIPTION Mitomycin (also known as mitomycin-C) is an alkylating drug isolated from the broth of Streptomyces . Mitomycin is a blue-violet crystalline powder with a molecular formula of C 15 H 18 N 4 O 5 , and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane, and it has the following structural formula: Mitomycin is heat stable, has a high melting point, and is freely soluble in organic solvents.

ZUSDURI is supplied in a kit containing two vials of sterile lyophilized mitomycin for intravesical solution, 40 mg each, and one vial of 60 mL of sterile hydrogel, to be used as a vehicle for reconstitution. Mitomycin for intravesical solution is a sterile, lyophilized, grey to greyish-purple, cake or powder that contains mitomycin 40 mg and mannitol 80 mg in each vial. Hydrogel is a sterile, clear, colorless gel with or without bubbles at room temperature or clear, colorless liquid at 2°C to 8°C (36°F to 46°F), which contains 0.11 g hydroxypropyl methylcellulose, 17.12 g poloxamer, 0.63 g polyethylene glycol, and water for injection in each vial.

Once reconstituted, ZUSDURI is a clear, purple, viscous liquid at 2°C to 8°C (36°F to 46°F) or semisolid gel at room temperature, which may contain a few visible particles and have a pH between 6.0 and 8.0. Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare providers of a known or suspected pregnancy [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1) ] .

Advise females of reproductive potential to use effective contraception during treatment with ZUSDURI and for 6 months following the last dose [see Use in Specific Populations (8.3) ] . Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZUSDURI and for 3 months following the last dose [see Use in Specific Populations (8.3) ]. Lactation Advise women not to breastfeed during treatment with ZUSDURI and for 1 week following the last dose [see Use in Specific Populations (8.2) ].

Important Post-Treatment Instructions [see Dosage and Administration (2.4) ] Advise patients that ZUSDURI contains mitomycin which is a violet to blue color and may discolor urine following the instillation procedure. Advise patients to avoid contact with urine for at least 24 hours post-instillation [see Clinical Pharmacology (12.3) ]. Advise patients to avoid urine contact with skin by voiding sitting on a toilet, flushing the toilet several times after use, and to wash hands, perineum or glans with soap and water after each instillation procedure.

Advise patients to wash clothing soiled with urine promptly and separately from other clothing.

🧬 Pharmacokinetics 154 words ▾

12.3Pharmacokinetics The systemic exposure of mitomycin following instillation of 75 mg of mitomycin as ZUSDURI into the bladder was evaluated pre-instillation and hourly for up to six hours post-instillation in six patients. Mitomycin mean (range) maximum concentration (Cmax) is 2.3 ng/mL (0.2 to 8.9 ng/mL), which is less than 1% of the expected Cmax after intravenous administration. Metabolism Mitomycin is metabolized primarily in the liver, but metabolism occurs in other tissues as well.

It is believed that the rate of clearance is inversely proportional to the maximal serum concentration because of saturation of the degradative pathways. Excretion Following instillation into the bladder, ZUSDURI forms a semisolid gel which dissolves in the urine. Patients reported visible gel in urine for up to 24 hours (median 5 hours) after instillation.

Mitomycin is excreted unchanged in the urine. Systemically absorbed mitomycin is rapidly cleared from the serum and approximately 10% is excreted unchanged in the urine.

🧬 Pharmacodynamics 13 words ▾

12.2Pharmacodynamics Mitomycin exposure-response relationships and time course of pharmacodynamic response are unknown.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES ENVISION Study The efficacy of ZUSDURI was evaluated in ENVISION (NCT05243550), a single-arm, multicenter trial in 240 adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), of whom 223 were evaluable for response. LG-IR-NMIBC was defined as Ta disease, histologically confirmed by biopsy, having one or two of the following: the presence of multiple tumors, a solitary tumor > 3 cm, and/or early or frequent recurrence (≥ 1 occurrence of LG-NMIBC within 1 year of the current diagnosis).

Patients were required to have a previous occurrence of LG-NMIBC (Ta) treated by TURBT. The trial excluded patients with T1 tumors, or history of high-grade NMIBC within the previous two years, and/or those with prior intravesical chemotherapy within the prior two years (except for a single dose of intravesical chemotherapy immediately after any previous TURBT) and/or Bacillus Calmette-Guerin treatment within the previous year. Patients received 75 mg ZUSDURI via urinary catheter once a week for 6 weeks.

Assessment of tumor status was performed every 3 months by cystoscopy, for-cause biopsy, and urine cytology. The major efficacy outcome measures were complete response rate (CR) at 3 months (defined as no detectable disease in the bladder by cystoscopy, biopsy [if indicated], and urine cytology) and duration of response. The median age of patients was 70 years (range, 30-92 years); 62% were male; race was White (97.8%), Black (0.9%), Asian (0.9%), or not reported (0.4%); 1.3% were Hispanic/Latino.

Multiple tumors were present in 84% of patients, 6% had a tumor > 3 cm, 55% had a previous LG-NMIBC occurrence within 1 year of the current diagnosis, and all patients had a prior TURBT for LG-NMIBC. Efficacy results are summarized in Table 3. Table 3: Efficacy Results in ENVISION Efficacy Outcome Measure ZUSDURI N = 223 + Denotes ongoing response.

Complete Response Rate % (95% CI) 78% (72, 83) Duration of Response Based on observed duration of response for 173 patients who had a complete response. Range in months (0.0, 25.0+) % (n) with duration ≥ 12 months 79% (137)

🧪 Nonclinical Toxicology 85 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Adequate long-term studies in animals to evaluate carcinogenic potential from instillation of mitomycin into the bladder have not been conducted. Mitomycin has been found to be carcinogenic in rats and mice. At doses approximating the recommended intravenous clinical dose in humans, mitomycin produced a greater than 100% increase in tumor incidence in male Sprague-Dawley rats, and a greater than 50% increase in tumor incidence in female Swiss mice.

The effect of ZUSDURI on fertility is unknown.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 82 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Adequate long-term studies in animals to evaluate carcinogenic potential from instillation of mitomycin into the bladder have not been conducted. Mitomycin has been found to be carcinogenic in rats and mice. At doses approximating the recommended intravenous clinical dose in humans, mitomycin produced a greater than 100% increase in tumor incidence in male Sprague-Dawley rats, and a greater than 50% increase in tumor incidence in female Swiss mice.

The effect of ZUSDURI on fertility is unknown.

📚 References 7 words ▾

15 REFERENCES "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

📄 Patient Package Insert ~3 min read ▾

Patient Information ZUSDURI™ (zus-dur-ee) (mitomycin) for intravesical solution This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 06/2025 What is ZUSDURI?

ZUSDURI is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after you have previously received bladder surgery to remove tumor and it did not work or is no longer working. It is not known if ZUSDURI is safe and effective for use in children. Who should not receive ZUSDURI?

Do not receive ZUSDURI if you : have a hole or tear (perforation) of your bladder, have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI. See the end of this Patient Information leaflet for a complete list of the ingredients in ZUSDURI. Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you: have kidney problems. are pregnant or plan to become pregnant.

ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI.

Females who are able to become pregnant: Your healthcare provider will check to see if you are pregnant before starting treatment with ZUSDURI. You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose. Talk to your healthcare provider if you have questions about birth control options that are right for you.

Males being treated with ZUSDURI: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose. are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How will I receive ZUSDURI? ZUSDURI will be given to you by your healthcare provider. You will receive ZUSDURI 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter.

It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider's instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.

Ask your healthcare provider if you have any questions. After receiving ZUSDURI: ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours.

To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water. Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.

What are the possible side effects of ZUSDURI? The most common side effects of ZUSDURI include: increased blood creatinine levels increased blood potassium levels trouble with urination decreased red blood cell counts increase in certain blood liver tests increased or decreased white blood cell counts urinary tract infection blood in your urine Call your doctor for medical advice about possible side effects. You may report side effects to FDA at 1-800-FDA-1088.

You can also report side effects to UroGen Pharma at 1-855-987-6436. General information about ZUSDURI.… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR PHARMACY (IFP) ZUSDURI™ (zus-dur-ee) (mitomycin) for intravesical solution Purpose of this Instructions for Pharmacy This Instructions for Pharmacy contains information on how to prepare ZUSDURI using pharmacy supplies and a Chilling Block or other means of chilling. Intended Use of ZUSDURI ZUSDURI (mitomycin) for intravesical solution is indicated for the treatment of adult patients with recurrent low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC). Important Information You Need to Know Before Reconstituting ZUSDURI Reconstituted ZUSDURI must be prepared under chilled conditions.

ZUSDURI cannot be prepared without a Chilling Block or other means of chilling. Once reconstituted with sterile hydrogel, ZUSDURI will appear as a semisolid gel under room temperature conditions and as a viscous liquid under chilled conditions. Preparation of ZUSDURI must be performed under aseptic conditions.

Storage Conditions and Handling Before reconstitution, store ZUSDURI at room temperature, 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F). Avoid excessive heat over 40°C (104°F).

Protect from light. Storage Instructions for Reconstituted ZUSDURI: Instill reconstituted ZUSDURI as soon as possible. If not used immediately, store reconstituted ZUSDURI: under refrigeration at 2℃ to 8℃ (36°F to 46°F) for up to 7 days; or under refrigeration at 2℃ to 8℃ (36°F to 46°F) for up to 6 days followed by no more than 24 hours at room temperature, 20°C to 25°C (68°F to 77°F).

Discard 7 days after reconstitution. Protect from light. Avoid excessive heat over 40°C (104°F).

ZUSDURI is a hazardous drug. Procedures for Proper Handling and Disposal of hazardous drugs should be followed. Supplies Needed ZUSDURI available in a kit containing: Two vials of ZUSDURI, 40 mg per vial One vial of Sterile hydrogel, 60 mL One ZUSDURI admixture label ZUSDURI Prescribing Information (PI) ZUSDURI Instructions for Pharmacy (IFP) ZUSDURI Instructions for Administration (IFA) Pharmacy Supplies: (Provided by your facility) Do not substitute any of these components Two 20 mL Luer lock syringes Two 5 mL Luer lock syringes filled with 3 mL sterile water Three OnGuard ® 2 CSTD vial adaptors Four OnGuard ® 2 CSTD syringe adaptors Chilling Block or other means of chilling (device design may vary) Note: The day before the preparation, place the Chilling Block in the freezer at -20°C to -12°C (-4°F to 10.4°F).

Refer to the Chilling Block Instructions for Use for more information. Steps to Prepare ZUSDURI Admixture A. Freeze the Chilling Block 1.

The day before preparation, put the Chilling Block in the freezer at -20°C to -12°C (-4°F to 10.4°F). Note: Please refer to the Chilling Block Instructions for Use for additional information. B.

Prepare Supplies 1. Remove the Chilling Block from the freezer. 2.

Disinfect the Chilling Block as per your pharmacy's policy. Allow it to air dry, and then place it inside the hood or isolator. 3.

Connect vial adaptors to all three vials. 4. Connect syringe adaptors to both empty 20 mL syringes and both sterile water syringes.

5. Place one ZUSDURI vial, the sterile hydrogel vial, and both empty 20 mL syringes in the Chilling Block for approximately 20 minutes. Note: The Chilling Block has five compartments, but only four are needed.

The small vial compartment will not be used during this preparation. 6. Set the second ZUSDURI vial and both sterile water syringes aside for later use.

C. Reconstitute the First ZUSDURI Vial 1. Slowly fill one chilled 20 mL syringe with 14 mL of sterile hydrogel.

2. Slowly fill the other chilled 20 mL syringe with 13 mL of sterile hydrogel. 3.

Place both 20 mL syringes and the sterile hydrogel vial back in the Chilling Block. 4. Remove the chilled ZUSDURI vial from the Chilling Block.

5. Inject 3 mL of sterile water into the ZUSDURI vial. 6.

Gently swirl the ZUSDURI vial upright at least 20 times. Note: Do not invert or shake the vial. 7.

In… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL - 40 mg Kit Carton NDC 72493-106-03 Zusduri ™ (mitomycin) for intravesical solution 40 mg per Vial Attention Pharmacist: Reconstitution is required prior to dispensing. See the Instructions for Pharmacy before proceeding. SINGLE-DOSE KIT Warning: For Intravesical Use Only Rx Only Contents of Kit: 2 Single-Dose Vials of ZUSDURI (mitomycin) for intravesical solution, 40 mg per Vial.

1 Single-Dose Vial of Sterile Hydrogel, 60 mL per Vial 1 Admixture Label Full Prescribing Information Instructions for Pharmacy Instructions for Administration Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Avoid excessive heat over 40°C (104°F). Protect from light.

Store reconstituted ZUSDURI at 2°C to 8°C (36°F to 46°F) for up to 7 days. Alternatively, reconstituted ZUSDURI may be stored under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 6 days followed by no more than 24 hours at room temperature, 20°C to 25°C (68°F to 77°F). Avoid excessive heat over 40°C (104°F).

Protect reconstituted ZUSDURI from light. When ready to instill, chill ZUSDURI at -3°C to 5°C (27°F to 41°F) for about 20 minutes to revert it to a viscous liquid. Recommended Dosage: See Full Prescribing Information.

Warning: Hazardous Drug Distributed by: UroGen Pharma, Inc. Princeton, NJ 08540 UroGen ® Pharma PRINCIPAL DISPLAY PANEL - 40 mg Kit Carton

PRINCIPAL DISPLAY PANEL - 40 mg Vial Label NDC 72493-104-40 Single-Dose Vial Sterile Zusduri ™ (mitomycin) for intravesical solution 40 mg per Vial See Instructions for Pharmacy for preparation instructions Must be Reconstituted with Sterile Hydrogel Before Use Warning: For Intravesical Use Only Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Avoid excessive heat over 40°C (104°F). Protect from light.

Each vial contains: Mitomycin 40 mg and mannitol 80 mg. Recommended Dosage: See Full Prescribing Information. Distributed by: UroGen Pharma, Inc.

Princeton, NJ 08540 Lot Exp Warning: Hazardous Drug Rx Only UroGen ® Pharma 620565 LBL-0017642/Ver. 1 PRINCIPAL DISPLAY PANEL - 40 mg Vial Label

PRINCIPAL DISPLAY PANEL - 60 mL Vial Label NDC 72493-105-60 Single-Dose Vial Sterile Hydrogel For use in preparation of ZUSDURI™ (mitomycin) for intravesical solution Not for Direct Administration See Instructions for Pharmacy for preparation instructions Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Avoid excessive heat over 40°C (104°F). Rx Only 60 mL per Vial LBL-0017641/Ver.

1 PRINCIPAL DISPLAY PANEL - 60 mL Vial Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Mitomycin (matched by generic name) — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Mitomycin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$74.8K
Claims incl. refills
56
Beneficiaries
39
Spend / beneficiary
$1,916.80
Spend / claim
$1,334.92
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Mitomycin — the ingredient across all brands.

Top reported reactions

Nausea170
Diarrhoea158
Rash122
Fatigue121
Thrombocytopenia110
Vomiting109
Neutropenia108

Age at onset

Child4
Adult175
Elderly149

Reporter sex

3,418 reports
Male · 49%
Female · 49%
Unknown · 2%

Serious outcomes

Hospitalization983
Death392
Life-threatening178
Disabling59
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 212 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by UroGen Pharma, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
UroGen Pharma, Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9282 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 72493-0103-03 · UroGen 72495-0201-05 · Millicent →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.