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Daunorubicin

Daunorubicin is a chemotherapy medicine used intravenously to treat acute nonlymphocytic leukemia in adults and acute lymphocytic leukemia in both children and adults.

Brand name Cerubidine
Drug classes Anthracycline Topoisomerase Inhibitor
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 3 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 8, 2026
Daunorubicin 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

Daunorubicin (Cerubidine) is an IV anthracycline chemotherapy that wedges into cancer cell DNA and blocks topoisomerase II (a DNA-copying enzyme). It is a backbone of combination treatment to bring acute myeloid (nonlymphocytic) leukemia in adults and acute lymphocytic leukemia in children and adults into remission, has been on the market since about 1994, and is available as a generic. It is a hard treatment, and most people notice hair loss, nausea and mouth sores. The boxed warning covers heart damage, even years after treatment, profound bone marrow suppression with infection and bleeding risk, and severe tissue damage if it leaks from the vein, so report IV site pain immediately.

Clinical pearls

  • Keep a written record of every anthracycline you receive, including doxorubicin, because heart risk builds with the lifetime total.
  • Tell your team about any past chest radiation or chemotherapy, since cyclophosphamide given alongside can add to heart risk.
  • Call promptly for fever, chills, unusual bruising or bleeding, breathlessness or swelling, since blood counts and heart function both need watching.
  • Mouth sores often show up 3 to 7 days after a dose, so start gentle mouth care early.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Daunorubicin Hydrochloride carries several critical safety warnings that every patient should know. First, it must only be given directly into a vein (IV) — never into muscle or skin. If it leaks out of the vein during infusion (called extravasation), it can cause severe, permanent tissue damage at the injection site. Second, this drug can cause serious heart damage — including potentially fatal heart failure — either during treatment or months to years afterward. The risk is higher once the total lifetime dose exceeds certain limits, and is even higher in young children and older adults. Third, it powerfully suppresses bone marrow (where blood cells are made), which can lead to life-threatening infections or severe bleeding. Fourth, it should only be given by doctors who specialize in leukemia chemotherapy, at facilities fully equipped to respond to severe complications. Finally, doses must be reduced in patients with liver or kidney problems.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asInjection
Earliest FDA record1979
Companies listing it with the FDA3
FDA label last updatedFeb 15, 2024
FDA’s strongest warning (boxed)Yes, read the warning

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

What Daunorubicin is used for

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Daunorubicin is a chemotherapy agent approved for use in combination with other anticancer drugs to induce remission in certain types of leukemia.

  • Acute nonlymphocytic leukemia (adults): Daunorubicin Hydrochloride Injection is indicated for remission induction in the myelogenous, monocytic, and erythroid subtypes in adults, used alongside other approved chemotherapy medicines.
  • Acute lymphocytic leukemia (children and adults): Daunorubicin Hydrochloride Injection is indicated for remission induction in both pediatric and adult patients, used in combination regimens.

How Daunorubicin works

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Daunorubicin kills cancer cells by inserting itself between the strands of DNA inside the cell — a process called intercalation. It also locks an enzyme called topoisomerase II (which cancer cells need to unwind and repair DNA) into a form that causes DNA strand breaks. The result: cancer cells can no longer replicate properly and die. Daunorubicin may additionally block other processes involved in DNA copying and generate free radicals (damaging unstable molecules) that further injure cancer cell DNA.

Daunorubicin dosage

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Daunorubicin Hydrochloride is given intravenously (into a vein) by a healthcare professional in a hospital or clinic setting. It is never taken by mouth. Doses are given on specific scheduled days within each treatment cycle — for example, on days 1, 2, and 3 of a course — and courses may be repeated based on how well the bone marrow responds.

  • Dosing schedules differ depending on whether you have acute nonlymphocytic leukemia or acute lymphocytic leukemia, and on your age.
  • Doses are reduced if you have liver or kidney problems.
  • Your oncology team will determine your personal schedule — always follow their instructions exactly.

Dosing details from the FDA-approved label

From the Daunorubicin 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.

  • Remission induction in adult acute nonlymphocytic leukemia, patients under age 60 (in combination)
    • Daunorubicin hydrochloride 45 mg/m2/day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m2/day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses
    • May require up to three courses of induction therapy to attain a normal-appearing bone marrow
  • Remission induction in adult acute nonlymphocytic leukemia, patients 60 years of age and above (in combination)
    • Daunorubicin hydrochloride 30 mg/m2/day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m2/day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses
    • Dose reduction is based on a single study and may not be appropriate if optimal supportive care is available
  • Remission induction in pediatric acute lymphocytic leukemia (in combination)
    • Daunorubicin hydrochloride 25 mg/m2 IV on day 1 every week, vincristine 1.5 mg/m2 IV on day 1 every week, prednisone 40 mg/m2 PO daily
    • In children less than 2 years of age or below 0.5 m2 body surface area, calculate dose by weight (1 mg/kg) instead of body surface area
  • Remission induction in adult acute lymphocytic leukemia (in combination)
    • Daunorubicin hydrochloride 45 mg/m2/day IV on days 1, 2, and 3 AND vincristine 2 mg IV on days 1, 8, and 15
    • Prednisone 40 mg/m2/day PO on days 1 through 22, then tapered between days 22 to 29
    • L-asparaginase 500 IU/kg/day x 10 days IV on days 22 through 32
  • Hepatic impairment (serum bilirubin 1.2 to 3 mg%)
    • Dose reduction of 25%
    • Serum bilirubin >3 mg%: 50% dose reduction
  • Renal impairment (serum creatinine >3 mg%)
    • Dose reduction of 50%
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit. Principles In order to eradicate the leukemic cells and induce a complete remission, a profound suppression of the bone marrow is usually required. Evaluation of both the peripheral blood and bone marrow is mandatory in the formulation of appropriate treatment plans. It is recommended that the dosage of daunorubicin hydrochloride injection be reduced in instances of hepatic or renal impairment. For example, using serum bilirubin and serum creatinine as indicators of liver and kidney function, the following dose modifications are recommended: Serum Bilirubin Serum Creatinine Dose Reduction 1.2 to 3 mg% — 25% >3 mg% — 50% — >3 mg% 50% Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Nonlymphocytic Leukemia: In Combination For patients under age 60, daunorubicin hydrochloride injection 45 mg/m 2 /day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m 2 /day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses. For patients 60 years of age and above, daunorubicin hydrochloride injection 30 mg/m 2 /day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m 2 /day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses. This daunorubicin hydrochloride injection dose-reduction is based on a single study and may not be appropriate if optimal supportive care is available. The attainment of a normal-appearing bone marrow may require up to three courses of induction therapy. Evaluation of the bone marrow following recovery from the previous course of induction therapy determines whether a further course of induction treatment is required. Representative Dose Schedule and Combination for the Approved Indication of Remission Induction in Pediatric Acute Lymphocytic Leukemia: In Combination Daunorubicin hydrochloride injection 25 mg/m 2 IV on day 1 every week, vincristine 1.5 mg/m 2 IV on day 1 every week, prednisone 40 mg/m 2 PO daily.

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

Daunorubicin side effects

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Like all strong chemotherapy medicines, daunorubicin causes side effects. The most important ones to know about include:

Common side effects

  • Hair loss (usually reversible)
  • Nausea and vomiting (typically mild)
  • Mouth sores (mucositis), often 3–7 days after a dose
  • Diarrhea or abdominal pain
  • Skin rash or hives (rare)
  • Fever and chills (rare)
  • Hair loss — occurs in most patients but is typically reversible after treatment ends
  • Nausea and vomiting — usually mild; anti-nausea medicines can help
  • Skin rash, contact dermatitis, or hives — rare
  • Fever and chills — rare acute reactions
  • Elevated uric acid — especially in leukemia patients; blood levels will be monitored

When to get medical help

  • Call your doctor right away if you notice swelling, shortness of breath, or unusual fatigue — these can be signs of heart failure
  • Get immediate help if you have pain, redness, or blistering at the IV site — the drug can severely damage tissue if it leaks out of the vein
  • Contact your care team if you develop signs of infection (fever, chills, sweating) — this drug suppresses the bone marrow and lowers your ability to fight infection
  • Seek help right away for unusual bleeding or bruising — low blood cell counts can cause dangerous bleeding
  • Tell your doctor about severe or worsening nausea, vomiting, or mouth sores that prevent eating or drinking
  • Report any signs of a severe allergic reaction: hives, difficulty breathing, or sudden dizziness

The two most serious and dose-limiting side effects are bone marrow suppression (which raises infection and bleeding risk) and heart toxicity — both are closely monitored during treatment. Seek immediate medical attention if you develop shortness of breath, chest discomfort, fever, unusual bleeding, or pain and redness at the IV site.

Daunorubicin warnings and precautions

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  • Heart toxicity: Daunorubicin can damage the heart muscle, potentially causing heart failure — either during treatment or years later. Risk increases with higher lifetime doses and is greater in children and older adults. An EKG and heart function tests are done before each treatment course. Prior therapy with doxorubicin or radiation to the chest further raises this risk.
  • Bone marrow suppression: This drug lowers production of all blood cells in every patient who receives it. Low white blood cells raise infection risk; low platelets raise bleeding risk. Blood counts are monitored closely, and treatment facilities must be prepared to manage severe infection or hemorrhage.
  • IV site damage (extravasation): If daunorubicin leaks out of the vein during infusion, it causes severe local tissue destruction. Report any pain, swelling, or burning at the injection site immediately.
  • Secondary leukemias: There are reports of new leukemias developing in some patients treated with topoisomerase II inhibitors (the class daunorubicin belongs to) in combination with other chemotherapy or radiation.
  • Fetal harm: Daunorubicin can cause birth defects and pregnancy loss. Women who can become pregnant should avoid becoming pregnant during treatment.
  • Liver and kidney impairment: Reduced function of either organ increases drug toxicity; doses must be adjusted accordingly.

Daunorubicin interactions

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Several medicines can interact with daunorubicin in ways that increase the risk of serious side effects.

  • Doxorubicin (prior use): Having received doxorubicin before significantly increases the risk of heart damage with daunorubicin. Your total lifetime exposure to both drugs is carefully tracked.
  • Cyclophosphamide (concurrent use): Taking cyclophosphamide at the same time as daunorubicin may increase the risk of heart toxicity.
  • Other bone marrow–suppressing agents: Using other medicines that lower blood cell counts at the same time can worsen bone marrow suppression; dose reductions may be required.
  • High-dose methotrexate and other hepatotoxic drugs: Medicines that can harm the liver may slow how daunorubicin is processed, increasing the risk of toxicity.
  • Heparin: Daunorubicin must not be mixed with heparin in the same IV line — a physical incompatibility exists.

Interactions listed in the FDA-approved label

From the Daunorubicin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Doxorubicin: Use of daunorubicin in a patient who has previously received doxorubicin increases the risk of cardiotoxicity. Daunorubicin hydrochloride should not be used in patients who have previously received the recommended maximum cumulative doses of doxorubicin or daunorubicin hydrochloride.
  • Cyclophosphamide: Used concurrently with daunorubicin hydrochloride may also result in increased cardiotoxicity.
  • Other myelosuppressive agents: Concurrent use may require daunorubicin dosage reduction. Dosage reduction of daunorubicin hydrochloride may be required.
  • Hepatotoxic medications, such as high-dose methotrexate: May impair liver function and increase the risk of toxicity.
  • Heparin and other drugs (admixture): Daunorubicin hydrochloride should not be administered mixed with other drugs or heparin. Do not mix with other drugs or heparin.
Read the label’s full interactions text

Drug Interactions Use of daunorubicin in a patient who has previously received doxorubicin increases the risk of cardiotoxicity. Daunorubicin hydrochloride should not be used in patients who have previously received the recommended maximum cumulative doses of doxorubicin or daunorubicin hydrochloride. Cyclophosphamide used concurrently with daunorubicin hydrochloride may also result in increased cardiotoxicity. Dosage reduction of daunorubicin hydrochloride may be required when used concurrently with other myelosuppressive agents. Hepatotoxic medications, such as high-dose methotrexate, may impair liver function and increase the risk of toxicity.

Read the full Drug Interactions section on DailyMed →

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.

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

Before taking Daunorubicin

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  • Allergy: Do not use daunorubicin if you have had a hypersensitivity (allergic) reaction to it before.
  • Heart disease or prior anthracycline therapy: Tell your doctor if you have existing heart disease or have previously received doxorubicin or daunorubicin — these greatly increase your cardiac risk.
  • Prior bone marrow suppression: Treatment should not begin if you already have drug-induced bone marrow suppression unless the benefit clearly outweighs the risk.
  • Liver or kidney disease: Significant impairment of either organ requires dose reduction to avoid excess toxicity.
  • Older adults: The elderly face higher risk of heart toxicity and bone marrow suppression, and age-related kidney decline may require dose adjustment.
  • Children (especially under age 2): Young children are more susceptible to heart damage, which can appear years after treatment ends; long-term heart monitoring is strongly recommended.
  • Pregnancy: This drug can cause fetal harm, including birth defects and pregnancy loss. Tell your doctor if you are pregnant or could become pregnant. Women of childbearing potential should avoid pregnancy during treatment.
  • Prior chest radiation: Radiation therapy to the chest area lowers the safe cumulative dose threshold for daunorubicin-related heart damage.

What Daunorubicin does in the body

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Daunorubicin exerts its effects by disrupting DNA function in cancer cells — causing strand breaks and blocking the ability of cells to divide. It suppresses bone marrow activity in all patients who receive a therapeutic dose, which is an expected and monitored consequence of treatment. At higher cumulative doses, it produces measurable changes in heart muscle function, detectable on an EKG as decreased QRS voltage or reduced ejection fraction (the amount of blood the heart pumps with each beat).

How your body processes Daunorubicin

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After IV injection, daunorubicin moves rapidly out of the bloodstream and into body tissues — it reaches its highest concentrations in the spleen, kidneys, liver, lungs, and heart. Within an hour, most of the drug in the blood has been converted by the liver into an active breakdown product called daunorubicinol, which itself has anti-cancer activity and takes about 26–27 hours to clear. The drug is extensively processed by the liver, and about 25% is excreted in urine while roughly 40% leaves through bile. There is no evidence that daunorubicin crosses into the brain, but it does cross the placenta. Patients with liver or kidney impairment clear the drug more slowly and require dose reductions.

How to store Daunorubicin

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Store unopened vials in refrigerator, 2° to 8°C (36° to 46°F). Store prepared solution for infusion at room temperature, 20° to 25°C (68° to 77°F) for up to 24 hours. Protect from light.

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

7

Supplements & herbs that interact with Daunorubicin

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

ACEROLA Moderate ALPHA-LIPOIC ACID Moderate GLUCOSAMINE Moderate ROSE HIP Moderate TURMERIC Moderate VITAMIN C Moderate VITAMIN E Moderate
Every supplement checked against Daunorubicin — ranked by severity The full interaction hub: 7 moderate · every one linked to its full report. Check Daunorubicin 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.

Daunorubicin: pharmacist answers to common questions

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

What exactly is daunorubicin used for?

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Daunorubicin is a chemotherapy drug used to treat two types of leukemia — acute nonlymphocytic leukemia in adults, and acute lymphocytic leukemia in both children and adults. It's always used together with other chemotherapy medicines, not on its own, and the goal is to bring the leukemia into remission — meaning the cancer signs decrease or disappear.

How will I receive this medicine?

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You'll receive daunorubicin through an IV — directly into a vein — at a hospital or cancer clinic. It's never given as a pill and must never be injected into muscle or skin. Treatment happens on specific days within a cycle, and your oncology team will walk you through exactly what to expect on each treatment day.

What side effects are most likely, and which ones should I call about right away?

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Most people experience hair loss (which usually grows back), mild nausea and vomiting, and mouth sores a few days after treatment. These are expected and manageable. However, you should call your care team immediately if you develop a fever, unusual bleeding or bruising, shortness of breath, swelling, or any pain or redness at your IV site — these can be signs of serious problems like infection, bleeding, or heart issues that need prompt attention.

I've heard this drug can affect the heart. Should I be worried?

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Heart toxicity is a real and important risk with daunorubicin, so your team takes it seriously. Your heart function will be checked with an EKG or imaging before each treatment course. The risk goes up if you've previously received doxorubicin, had chest radiation, or if you're a young child or older adult. The good news is that careful monitoring helps catch early changes so your doctors can act before serious damage occurs. Make sure your team knows your complete treatment history.

Can I take my other medications while on daunorubicin?

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Some medicines can interact with daunorubicin and increase serious risks — for example, cyclophosphamide raises the chance of heart toxicity, and high-dose methotrexate can affect how daunorubicin is processed by your liver. Tell your oncology team about every medication you take, including any prior chemotherapy drugs like doxorubicin, so they can adjust your treatment plan if needed.

Is it safe to become pregnant while receiving this treatment?

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No — daunorubicin can seriously harm a developing baby and has been associated with birth defects and pregnancy loss in studies. If you could become pregnant, you should use effective contraception and avoid getting pregnant during treatment. If there is any chance you are already pregnant, tell your doctor immediately before starting this drug.

Is Daunorubicin available over the counter?

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No. Daunorubicin is a prescription medicine: every Daunorubicin 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 Daunorubicin first available?

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The earliest FDA record we hold for Daunorubicin is from 1979: 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 Daunorubicin was first used.

Who makes Daunorubicin?

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3 companies currently list Daunorubicin products in the FDA's NDC Directory, including Hikma Pharmaceuticals USA Inc., Hisun Pharmaceuticals USA, Inc., Meitheal Pharmaceuticals 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 Daunorubicin on HelloPharmacist

📊Daunorubicin supplement interactions7 checked — ranked by severity 🌿Drug & Supplement CheckerDaunorubicin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Daunorubicin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Daunorubicin 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.

Daunorubicin forms and strengths (how it comes)

Daunorubicin 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.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Daunorubicin inactive ingredients by manufacturer.

Injection

Into a vein
How this form is used
What it may be used for
  • Daunorubicin Hydrochloride Injection is used in combination with other anticancer drugs to induce remission in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid types) in adults
  • Daunorubicin Hydrochloride Injection is used in combination with other anticancer drugs to induce remission in acute lymphocytic leukemia in both children and adults
Important instructions
  • Daunorubicin Hydrochloride Injection must be given only into a rapidly flowing IV infusion — never into muscle or under the skin
  • Daunorubicin Hydrochloride Injection must not be mixed in the same IV line with heparin or other medications
  • Daunorubicin Hydrochloride Injection is given on specific days of each treatment cycle as directed by your oncology team; doses are adjusted for liver or kidney impairment
  • If Daunorubicin Hydrochloride Injection contacts skin or mucous membranes during preparation, the area should be washed thoroughly with soap and water
Available strengths 1 strength
5 mg/mL
10 FDA-listed product records ⓘ

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

How Daunorubicin 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.

3 companies list 5 Daunorubicin product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1979. Brand names on the directory include Cerubidine; the rest are generics.

1
Dose forms ⓘ
3
Labelers (makers, repackagers, distributors)
1
Brand names
5
FDA-listed product records ⓘ
1979
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Hikma Pharmaceuticals USA Inc.40%
Hisun Pharmaceuticals USA, Inc.40%
Meitheal Pharmaceuticals Inc.20%

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

How widely Daunorubicin is used (Medicaid data)

A general measure of how commonly Daunorubicin 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 Daunorubicin 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.

67
Medicaid prescriptions filled (Q1–Q4 2025)
$18,749 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Daunorubicin prescribed? Of the 1,601 medications we measure, Daunorubicin ranks #1,531 by Medicaid prescriptions — more than 4% of them.

Where Daunorubicin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,531 of 1,601
#1,526 Capmatinib 72 Rx #1,527 Mitotane 70 Rx #1,528 Auranofin 69 Rx #1,529 Argatroban 69 Rx #1,530 Rituximab and Hyaluron... 68 Rx #1,531 Pramlintide Injection 67 Rx #1,532 Daunorubicin 67 Rx #1,533 Indomethacin Rectal 66 Rx #1,534 Odevixibat 61 Rx #1,535 Toremifene 60 Rx #1,536 Tivozanib 60 Rx

Utilization by Daunorubicin 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.

4 ML daunorubicin 5 MG/ML Injection

67 Medicaid prescriptions (Q1–Q4 2025) 100% of Daunorubicin prescriptions shown $18,749 gross reimbursement (before rebates) ≈ $280 per prescription (gross)

Summed across the 1 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 309650

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 Daunorubicin, 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 1 of 10 listed Daunorubicin NDCs with Medicaid activity.

Compare Daunorubicin products

A representative set of FDA-listed product records for Daunorubicin — 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.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Injection
5 mg/mL Intravenous Hikma Pharmaceuticals USA Inc. × 2 listings NDA View NDC →
5 mg/mL Intravenous Hisun Pharmaceuticals USA, Inc. × 2 listings ANDA View NDC →
5 mg/mL Intravenous Meitheal Pharmaceuticals Inc. ANDA View NDC →

Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Daunorubicin NDCs →

Daunorubicin FDA approval history

How Daunorubicin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Daunorubicin was first approved by the FDA in 1979 (Brand: CERUBIDINE · Wyeth Ayerst); the first generic version was approved in 1980. It remains available in U.S. pharmacies today.

1979
Brand approved
Brand: CERUBIDINE · Wyeth Ayerst
1980
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Daunorubicin 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 Daunorubicin recalls since July 2021.

✅No Daunorubicin 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) Daunorubicin RxCUI 3109 1 dose form · 2 strengths

Look up RxCUI 3109 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.

Daunorubicin brand names

Daunorubicin is sold under one brand name in the FDA directory — Cerubidine. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Cerubidine

Who makes Daunorubicin: manufacturers and labelers

3 companies list Daunorubicin products with the FDA. By number of product records, the largest are Hikma Pharmaceuticals USA Inc., Hisun Pharmaceuticals USA, Inc., Meitheal Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Hikma Pharmaceuticals USA Inc. 2 Hisun Pharmaceuticals USA, Inc. 2 Meitheal Pharmaceuticals Inc. 1

Daunorubicin drug class (RxNorm)

Daunorubicin belongs to the Anthracycline Topoisomerase Inhibitor class.

Pharmacologic class Anthracycline Topoisomerase Inhibitor
Drug family (ATC) Anthracyclines and related substances
How it works Topoisomerase Inhibitors

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 Daunorubicin 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 Feb 15, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Daunorubicin.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Daunorubicin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
3
Finished products in the current FDA directory
5
Companies listing them (makers, repackagers, distributors)
3
FDA labeler codes behind them ⓘ
3
Linked representative label ⓘ
Hikma Pharmaceuticals USA Inc.
Linked label effective
Feb 15, 2024
Composite sections available
19
Linked SPL Set ID
227784a8-ce68-4dd4-8ac5-a65265969677
Linked SPL Document ID
d77dc365-6db8-4bdc-81fc-7ac80bcc7699
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. Hikma Pharmaceuticals USA Inc. 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 →