Prescription medicine
Daunorubicin First approved as Cerubidine
Daunorubicin (Cerubidine) is a prescription medicine with an FDA approval on record since 1979. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the daunorubicin FDA label on DailyMed (effective January 19, 2026, Hisun Pharmaceuticals USA, Inc.); the NDA 50484 record on Drugs@FDA; every daunorubicin label on DailyMed.
Highlights of the record
FDA label of January 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Daunorubicin Hydrochloride Injection must be given into a rapidly flowing intravenous infusion. It must never be given by the intramuscular or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration. Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The incidence of myocardial toxicity increases after a total cumulative dose exceeding 400 to 550 mg/m 2 in adults, 300 mg/m 2 in children more than 2 years of age, or 10 mg/kg in children less than 2 years of age. Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage. It is recommended that daunorubicin hydrochloride be administered only by physicians who are experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection. Dosage should be reduced in patients with impaired hepatic or renal function.
Used for
From the label: indications and usageDaunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
Forms and strengths
- 5 mg/ml
Injection (solution); injection.
On the market
- Earliest approval on file
- December 19, 1979 Cerubidine, Wyeth Ayerst; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first February 5, 1980; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest July 29, 2021
- FAERS reports
- 1,580 through July 30, 2026
What is daunorubicin used for?
From the label: indications and usageDaunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
Conditions named in the indications of daunorubicin's FDA labels, with every medicine labeled for each:
From other daunorubicin labelsLeukemia, lymphoma and myeloma: INDICATIONS AND USAGE Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for …
FDA pharmacologic class: Anthracycline Topoisomerase Inhibitor.
Source: FDA drug label (Daunorubicin Hydrochloride), Hisun Pharmaceuticals USA, Inc., effective January 19, 2026 (SPL set 9705fa12-499e-41a3-8fb4-f6df0858b851), via openFDA; the full label on DailyMed
Is there a generic for daunorubicin (Cerubidine)?
The FDA approved the first generic daunorubicin on February 5, 1980. 8 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists daunorubicin from 2 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1979 earliest approval on file
- 1980 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has daunorubicin been recalled?
The FDA's Enforcement Report lists 2 recalls naming daunorubicin since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 29, 2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility |
| October 11, 2013 | Class II | Teva Pharmaceuticals USA | Presence of Precipitate; precipitation of drug product |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the daunorubicin label say about other medicines?
The daunorubicin label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name daunorubicin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclophosphamide | drug interactions | Cyclophosphamide used concurrently with daunorubicin hydrochloride may also result in increased cardiotoxicity. |
| Doxorubicin | drug interactions | Drug Interactions Use of daunorubicin in a patient who has previously received doxorubicin increases the risk of cardiotoxicity. |
| Methotrexate | drug interactions | Hepatotoxic medications, such as high-dose methotrexate, may impair liver function and increase the risk of toxicity. |
Other labels that name daunorubicin
Source: FDA drug label (Daunorubicin Hydrochloride), Hisun Pharmaceuticals USA, Inc., effective January 19, 2026 (SPL set 9705fa12-499e-41a3-8fb4-f6df0858b851), via openFDA; the full label on DailyMed
What do FAERS reports show for daunorubicin?
The FDA Adverse Event Reporting System holds 1,580 reports that list daunorubicin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 394 are coded as a death and 729 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as daunorubicin?
35 other medicines are given the same way (intravenous) and in the same FDA class as daunorubicin or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Clofarabine | Leukemia, lymphoma and myeloma | 9 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as daunorubicin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to daunorubicin
- 35 medicines for the same use
- Other anthracycline topoisomerase inhibitors
- the pharmacologic class, with prices and generics
- Daunorubicin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other