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Mitomycin

Mitomycin is a chemotherapy medicine (an alkylating or DNA-blocking drug) used for stomach and pancreatic cancer that has spread, certain bladder and upper urinary tract cancers, and as an add-on during glaucoma surgery, depending on the product.

Brand names MitosolJelmytoZusduri
Drug class Alkylating Drug
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 19 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 4, 2026
Mitomycin at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Mitomycin is a chemotherapy standby, on the market since about 1981 and available generically, that cross-links DNA to stop cells dividing; the injection pairs with other drugs for stomach or pancreatic cancer that has spread, while other brands treat low-grade bladder and upper urinary tract cancers or aid glaucoma surgery. It is a tough drug, with nausea, vomiting and tiredness common; Jelmyto adds flank pain, blood in the urine and painful urination. Its boxed warning covers drops in platelets and white cells that invite bleeding and overwhelming infection, plus hemolytic uremic syndrome, which destroys red blood cells and can cause permanent kidney failure, so report fever, bruising or reduced urine promptly.

Clinical pearls

  • Blood counts are checked repeatedly during treatment and for at least eight weeks after, and courses wait for recovery.
  • Report pain, redness or skin breakdown where the IV went in, since leaked mitomycin can cause ulcers and tissue death.
  • With Jelmyto, flank pain plus fever can mean a blocked ureter (the tube draining the kidney) and needs prompt attention.
  • With Jelmyto or Zusduri, use effective contraception during treatment and for months afterward, since mitomycin can harm a developing baby.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Mitomycin should only be given by a doctor experienced in cancer chemotherapy, in a setting with proper testing and treatment facilities.

It commonly causes bone marrow suppression, meaning low platelets and white blood cells. This can lead to overwhelming infections, especially in people who are already weakened.

It can also cause hemolytic uremic syndrome (HUS). This is a serious condition with destruction of red blood cells, low platelets, and irreversible kidney failure. It can happen at any time during systemic treatment, and most cases occur at higher total doses. Blood transfusions may make it worse. Report signs of infection, bleeding, or kidney problems right away.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asInjection
Earliest FDA record1996
Companies listing it with the FDA13
FDA label last updatedJun 9, 2021
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Mitomycin, written from its FDA label.

What Mitomycin is used for

▾

Mitomycin is used in several cancer and eye surgery settings, depending on the product.

  • Mutamycin and Mitomycin (intravenous injection): disseminated adenocarcinoma of the stomach or pancreas, in combination with other approved chemotherapy, and as palliative treatment when other approaches have failed.
  • Zusduri: adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
  • Jelmyto: adults with low-grade upper tract urothelial cancer.
  • Mitosol: an add-on during ab externo glaucoma surgery.

How Mitomycin works

▾

Mitomycin blocks the synthesis of DNA, which cells need in order to divide. It works by cross-linking DNA strands, and this relates to the guanine and cytosine content of the DNA. At high concentrations, it also suppresses RNA and protein production.

Mitomycin dosage

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Mutamycin and Mitomycin injection are given by a healthcare professional into a vein only, as a single dose through a working IV catheter. Courses are spaced several weeks apart, after blood counts have fully recovered from earlier chemotherapy.

  • Your team re-evaluates you after each course.
  • The dose is reduced if you had toxicity or low blood counts.
  • Higher doses were not shown to work better and are more toxic.

Follow your prescriber and the product label.

Dosing details from the FDA-approved label

From the Mitomycin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Mitomycin intravenous dosing after full hematological recovery from any previous chemotherapy
    • 20 mg/m2 intravenously as a single dose via a functioning intravenous catheter, at 6 to 8 week intervals
    • Maximum: Doses greater than 20 mg/m2 have not been shown to be more effective, and are more toxic than lower doses
    • Because of cumulative myelosuppression, reevaluate patients fully after each course and reduce the dose if any toxicities occurred; adjust by nadir: leukocytes >4000/mm3 and platelets >100,000/mm3 give 100% of prior dose; leukocytes 3000-3999 and platelets 75,000-99,999 give 100%; leukocytes 2000-2999 and platelets 25,000-74,999 give 70%
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Mitomycin for injection should be given intravenously only, using care to avoid extravasation of the compound. If extravasation occurs, cellulitis, ulceration, and slough may result. Each vial contains either mitomycin 5 mg and mannitol 10 mg, mitomycin, 20 mg and mannitol 40 mg or mitomycin 40 mg and mannitol 80 mg. To administer, add Sterile Water for Injection, 10 mL, 40 mL or 80 mL respectively. Shake to dissolve. If product does not dissolve immediately, allow to stand at room temperature until solution is obtained. After full hematological recovery (see guide to dosage adjustment) from any previous chemotherapy, the following dosage schedule may be used at 6 to 8 week intervals: 20 mg/m 2 intravenously as a single dose via a functioning intravenous catheter. Because of cumulative myelosuppression, patients should be fully reevaluated after each course of mitomycin, and the dose reduced if the patient has experienced any toxicities. Doses greater than 20 mg/m 2 have not been shown to be more effective, and are more toxic than lower doses. The following schedule is suggested as a guide to dosage adjustment: Nadir After Prior Dose L e uk o c y t e s / m m 3 P l a t e l e t s / m m 3 Percentage of Prior Dose To Be Given >4000 >100,000 100% 3000 to 3999 75,000 to 99,999 100% 2000 to 2999 25,000 to 74,999 70% <2000 <25,000 50% No repeat dosage should be given until leukocyte count has returned to 4000/mm 3 and a platelet count to 100,000/mm 3 . When mitomycin for injection is used in combination with other myelosuppressive agents, the doses should be adjusted accordingly. If the disease continues to progress after two courses of mitomycin for injection, the drug should be stopped since chances of response are minimal. STABILITY Unreconstituted mitomycin stored at room temperature is stable for the lot life indicated on the package. Avoid excessive heat (over 40°C, 104°F). Reconstituted with Sterile Water for Injection to a concentration of 0.5 mg per mL, mitomycin for injection is stable for 14 days refrigerated or 7 days at room temperature. Diluted in various I.V. fluids at room temperature, to a concentration of 20 to 40 micrograms per mL: I.V.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Mitomycin side effects

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Bone marrow suppression is the most common and most severe toxic effect. Other effects reported with Jelmyto include:

Common side effects

  • Low blood counts (bone marrow suppression), especially low platelets and white blood cells
  • Nausea and vomiting
  • Abdominal pain
  • Tiredness
  • Flank pain (Jelmyto)
  • Blood in the urine (Jelmyto)
  • Urinary tract infection (Jelmyto)
  • Painful urination (Jelmyto)
  • Ureteric obstruction
  • Kidney dysfunction

When to get medical help

  • Fever, chills, or other signs of infection, since low white blood cells can lead to serious or deadly infections
  • Unusual bruising or bleeding, which can signal low platelets
  • Reduced urine, swelling, or pale skin and fatigue, which could signal hemolytic uremic syndrome (HUS) or kidney problems
  • Pain, redness, or skin breakdown at the IV site, which can mean the drug leaked out of the vein
  • Flank pain or fever with Jelmyto, which can signal a blocked ureter (the tube from the kidney to the bladder)
  • Allergic reactions

Mitomycin warnings and precautions

▾
  • Bone marrow suppression: low platelets and white blood cells can cause serious or fatal infection. Blood counts are checked during treatment and for at least eight weeks after.
  • Hemolytic uremic syndrome (HUS): a serious complication with red blood cell destruction, low platelets, and irreversible kidney failure.
  • Kidney toxicity: mitomycin injection should not be given with serum creatinine above 1.7 mg percent.
  • Leakage from the vein: can cause cellulitis, ulceration, and tissue slough.
  • Pregnancy: can cause fetal harm.
  • Ureteric obstruction: a risk with Jelmyto.

Mitomycin interactions

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The label notes a few points to be aware of.

  • Other chemotherapy drugs: HUS can occur with mitomycin alone or combined with other cytotoxic drugs.
  • Blood transfusions: may worsen HUS symptoms.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿26 supplements and herbs with documented Mitomycin interactions, ranked by severity Check Mitomycin against a supplement or herb →

Before taking Mitomycin

▾
  • Kidney problems: mitomycin injection should not be given if serum creatinine is above 1.7 mg percent. Avoid Zusduri in severe kidney impairment.
  • Pregnancy: can cause fetal harm. Safe use in pregnancy has not been established.
  • Contraception: for Zusduri and Jelmyto, use effective contraception during treatment and for 6 months (females) or 3 months (males with female partners) after the last dose.
  • Breastfeeding: avoid during Zusduri treatment and for 1 week after.
  • Zusduri should not be used with bladder perforation or prior allergy to mitomycin.
  • Children: safety and effectiveness have not been established for Zusduri.
  • Older adults: no significant overall differences in safety or efficacy were seen with Zusduri.

What Mitomycin does in the body

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There is not enough data to describe how drug exposure relates to its effects or how those effects change over time.

How your body processes Mitomycin

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Mitomycin is broken down mainly in the liver, and also in other tissues. Systemically absorbed mitomycin is cleared quickly from the blood, and about 10% leaves unchanged in the urine. With Jelmyto, which is placed in the kidney area, the drug forms a gel that releases mitomycin over about 4 to 6 hours. Blood levels were less than 1% of those expected after an IV dose.

How to store Mitomycin

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Store dry powder at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F). Protect from light. Avoid excessive heat, over 40°C (104°F).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

26

Supplements & herbs that interact with Mitomycin

26 supplements and herbal products have documented interactions with Mitomycin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 15
  • Minor · 10
ACTIVATED CHARCOAL Major ACEROLA Moderate ALPHA-LIPOIC ACID Moderate COFFEE CHARCOAL Moderate DIMETHYLSULFOXIDE (DMSO) Moderate EUROPEAN MANDRAKE Moderate GLUCOMANNAN Moderate GUAR GUM Moderate +18 more
Every supplement checked against Mitomycin — ranked by severity The full interaction hub: 1 major · 15 moderate · 10 minor · every one linked to its full report. Check Mitomycin against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Mitomycin: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Mitomycin — the kind of thing our pharmacy team would talk through with you at the counter.

What is mitomycin used for?

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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 when other treatments have failed. Other mitomycin products treat certain bladder and upper urinary tract cancers or support glaucoma surgery.

How will I receive it?

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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 counts have recovered.

What side effects should I expect?

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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 drop too low.

When should I call my doctor right away?

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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 also needs prompt attention.

Is it safe during pregnancy?

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Mitomycin can harm an unborn baby, and animal studies showed birth defects. Tell your doctor if you are pregnant or could become pregnant. For Zusduri and Jelmyto, effective contraception is advised during treatment and for months afterward.

Do I need any lab tests?

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Yes. Platelets, white blood cells, and hemoglobin are checked repeatedly during treatment and for at least eight weeks afterward. Your kidney function is also watched closely.

Is Mitomycin available over the counter?

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No. Mitomycin is a prescription medicine: every Mitomycin product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Mitomycin first available?

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The earliest FDA record we hold for Mitomycin is from 1996: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Mitomycin was first used.

Who makes Mitomycin?

▾
13 companies currently list Mitomycin products in the FDA's NDC Directory, including BluePoint Laboratories, Hikma Pharmaceuticals USA Inc., Accord Healthcare, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Mitomycin on HelloPharmacist

📊Mitomycin supplement interactions26 checked — ranked by severity 🌿Drug & Supplement CheckerMitomycin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Mitomycin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Mitomycin Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Mitomycin forms and strengths (how it comes)

Mitomycin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Into a vein
How this form is used
What it may be used for
  • Mutamycin and Mitomycin are used with other approved chemotherapy drugs for disseminated adenocarcinoma of the stomach or pancreas.
  • Mutamycin and Mitomycin are also used as palliative treatment when other approaches have failed.
  • Mutamycin and Mitomycin are not recommended as single-agent primary therapy or to replace surgery or radiotherapy.
Important instructions
  • Mutamycin and Mitomycin are given into a vein only, with care to avoid leakage outside the vein.
  • Mutamycin and Mitomycin are given as a single dose through a working IV catheter, in courses spaced weeks apart after blood counts recover.
  • Mutamycin and Mitomycin doses may be reduced based on blood counts and toxicity.
Available strengths 5 strengths
5 mg/10 mL 20 mg 20 mg/40 mL 40 mg 40 mg/80 mL
49 FDA-listed product records ⓘ

Mitomycin on the U.S. market: products, makers and brands

How Mitomycin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

13 companies list 38 Mitomycin product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1996. Brand names on the directory include Mitosol, Jelmyto, Zusduri; the rest are generics.

1
Dose forms ⓘ
13
Labelers (makers, repackagers, distributors)
5
Brand names
38
FDA-listed product records ⓘ
1996
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (10) · Kit (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

BluePoint Laboratories16%
Hikma Pharmaceuticals USA Inc.11%
Accord Healthcare, Inc.8%
Archis Pharma LLC8%
Eugia US LLC8%
Fresenius Kabi USA, LLC8%
Other makers42%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Mitomycin is used (Medicaid data)

A general measure of how commonly Mitomycin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Mitomycin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

76
Medicaid prescriptions filled (Q1–Q4 2025)
$243,397 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Mitomycin prescribed? Of the 1,601 medications we measure, Mitomycin ranks #1,522 by Medicaid prescriptions — more than 5% of them.

Where Mitomycin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,522 of 1,601
#1,517 Inotuzumab Ozogamicin... 85 Rx #1,518 Meclofenamate 85 Rx #1,519 Lansoprazole, Clarithr... 84 Rx #1,520 Oritavancin Injection 79 Rx #1,521 Pramoxine 79 Rx #1,522 Cetirizine Ophthalmic 76 Rx #1,523 Mitomycin 76 Rx #1,524 Avapritinib 73 Rx #1,525 Teplizumab-mzwv inject... 73 Rx #1,526 Capmatinib 72 Rx #1,527 Mitotane 70 Rx

Utilization by Mitomycin product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 5 mg injection is the most-dispensed Mitomycin product — about 33% of these Medicaid prescriptions.

mitomycin 5 MG Injection Most dispensed

25 Medicaid prescriptions (Q1–Q4 2025) 33% of Mitomycin prescriptions shown $1,434 gross reimbursement (before rebates) ≈ $57 per prescription (gross)

Summed across the 1 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1740894

mitomycin 20 MG Injection

23 Medicaid prescriptions (Q1–Q4 2025) 30% of Mitomycin prescriptions shown $3,906 gross reimbursement (before rebates) ≈ $170 per prescription (gross)

Summed across the 2 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1740900

mitomycin 40 MG Powder for Pyelocalyceal Solution

16 Medicaid prescriptions (Q1–Q4 2025) 21% of Mitomycin prescriptions shown $235,594 gross reimbursement (before rebates) ≈ $14,725 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2375818

mitomycin 40 MG Injection

12 Medicaid prescriptions (Q1–Q4 2025) 16% of Mitomycin prescriptions shown $2,462 gross reimbursement (before rebates) ≈ $205 per prescription (gross)

Summed across the 1 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1740898

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Mitomycin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 51 listed Mitomycin NDCs with Medicaid activity.

Compare Mitomycin products

A representative set of FDA-listed product records for Mitomycin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 38 of 38 products — FDA National Drug Code Directory. See every product, package size and price: browse all 38 Mitomycin NDCs →

Mitomycin recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Mitomycin recalls since July 2021.

✅No Mitomycin recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Mitomycin RxCUI 632 4 dose forms · 6 strengths
  1. Dose form (SCDF) Injection RxCUI 1740893 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 1740894 20 MG RxCUI 1740900 40 MG RxCUI 1740898
  2. Dose form (SCDF) Ophthalmic Solution RxCUI 1244552 No current FDA listing
    Clinical drug / strength (SCD) 0.2 MG/ML RxCUI 1244553
  3. Dose form (SCDF) Powder for Intravesical Solution RxCUI 2719765 No current FDA listing
    Clinical drug / strength (SCD) 40 MG RxCUI 2719766
  4. Dose form (SCDF) Powder for Pyelocalyceal Solution RxCUI 2375817 No current FDA listing
    Clinical drug / strength (SCD) 40 MG RxCUI 2375818

Look up RxCUI 632 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Mitomycin brand names

Mitomycin is sold under 3 brand names in the FDA directory — Mitosol, Jelmyto, Zusduri. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Mitosol Jelmyto Zusduri

Who makes Mitomycin: manufacturers and labelers

13 companies list Mitomycin products with the FDA. By number of product records, the largest are BluePoint Laboratories, Hikma Pharmaceuticals USA Inc., Accord Healthcare, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

BluePoint Laboratories 6 Hikma Pharmaceuticals USA Inc. 4 Accord Healthcare, Inc. 3 Archis Pharma LLC 3 Eugia US LLC 3 Fresenius Kabi USA, LLC 3 Gland Pharma Limited 3 Meitheal Pharmaceuticals Inc. 3 Sagent Pharmaceuticals 3 Accord BioPharma Inc. 2 Bryant Ranch Prepack 2 UroGen Pharma, Inc 2 Mobius Therapeutics LLC 1

Mitomycin drug class (RxNorm)

Mitomycin belongs to the Alkylating Drug class.

Pharmacologic class Alkylating Drug
Drug family (ATC) Other cytotoxic antibiotics
How it works Alkylating Activity

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Mitomycin page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 9, 2021
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Mitomycin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Mitomycin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
19
Finished products in the current FDA directory
38
Companies listing them (makers, repackagers, distributors)
13
FDA labeler codes behind them ⓘ
14
Linked representative label ⓘ
BluePoint Laboratories
Linked label effective
Jun 9, 2021
Composite sections available
17
Linked SPL Set ID
aad9a9a0-7204-452a-8b9b-6d625c4ee021
Linked SPL Document ID
c455e123-6115-d234-e053-2995a90a2e93
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. BluePoint Laboratories is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →