Prescription medicine
Cyclophosphamide Brand names: Frindovyx; first approved as Cytoxan (Lyophilized)
Cyclophosphamide (Frindovyx) is a prescription medicine with an FDA approval on record since 1959. FDA's NDC Directory lists it from 19 generic labelers, and pharmacies paid $1.67 per cyclophosphamide 50 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the cyclophosphamide FDA label on DailyMed (effective January 19, 2026, Amneal Pharmaceuticals LLC); the NDA 12142 record on Drugs@FDA; every cyclophosphamide label on DailyMed.
Highlights of the record
FDA label of January 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCyclophosphamide for injection is an alkylating drug indicated for treatment of adults and pediatric patients with: Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma;
Forms and strengths
- 25 mg
- 50 mg
- 1 g/50ml
- 1 g/2ml
- 1 g/5ml
- 2 g/100ml
- 2 g/4ml
- 2 g/10ml
- 200 mg/ml
- 500 mg/25ml
- 500 mg/ml
- 500 mg/5ml
Injection (powder) for solution; injection; capsule; injection (powder) (lyophilized) for solution; injection (solution).
On the market
- Earliest approval on file
- November 16, 1959 Cytoxan (Lyophilized), Baxter Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 23 first February 16, 1982; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 25 of which 19 under generic applications, 8 under brand applications, repackagers included
- Last listed patent
- December 1, 2035 Frindovyx injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.67 per capsule Cyclophosphamide 50 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2018 2 Class I among all firms' recalls; latest July 17, 2026; 1 more by firms not listed as its makers
- FAERS reports
- 176,005 through July 30, 2026
What is cyclophosphamide used for?
From the label: indications and usageCyclophosphamide for injection is an alkylating drug indicated for treatment of adults and pediatric patients with: Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. ( 1.1 ) Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy. […]
Conditions named in the indications of cyclophosphamide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Alkylating Drug.
Source: FDA drug label (Cyclophosphamide), Amneal Pharmaceuticals LLC, effective January 19, 2026 (SPL set 520bfe39-dfd5-4a20-9a37-80078afded0d), via openFDA; the full label on DailyMed
Is there a generic for cyclophosphamide (Frindovyx)?
The FDA approved the first generic cyclophosphamide on February 16, 1982. 23 generic applications are approved; 15 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists cyclophosphamide from 19 labelers under a generic (ANDA) application and from 8 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Frindovyx injection, the last expiring on December 1, 2035; a patent listed only for Cyclophosphamide injection runs to February 15, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1959 earliest approval on file
- 1982 first generic approved
- 2035 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cyclophosphamide (Frindovyx)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.67 per Cyclophosphamide 50 mg capsule, down 20% from $2.08 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Cyclophosphamide 25 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cyclophosphamide 25 mg capsule | Generic | $1.12 per capsule | $33.64 | +13% |
| Cyclophosphamide 50 mg capsule | Generic | $1.67 per capsule | $50.12 | -20% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has cyclophosphamide been recalled?
The FDA's Enforcement Report lists 7 recalls naming cyclophosphamide since 2018: 2 Class I (the most serious), 3 Class II, 2 Class III; 3 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of cyclophosphamide and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 17, 2026 | Class I | Sunny Pharmtech Inc. | Presence of Particulate Matter; identified as stainless steel |
| September 5, 2025 | Class II | Sandoz Inc | cGMP deviations: Temperature excursion during transportation. |
| April 2, 2024 | Class III | X-Gen Pharmaceuticals Inc. | Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. … |
| June 12, 2019 | Class II | Infusion Options, Inc. not a listed maker | Lack of Assurance of Sterility |
| April 3, 2018 | Class II | Kroger Specialty Pharmacy, Inc. | Lack of Processing Controls. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cyclophosphamide label say about other medicines?
The cyclophosphamide label names 20 other medicines in its interaction, contraindication or warning sections. The labels of 46 other medicines name cyclophosphamide. 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 |
|---|---|---|
| Amiodarone | drug interactions | … Cytarabine ● Pentostatin ● Radiation therapy of the cardiac region ● Trastuzumab Increased pulmonary toxicity ● Amiodarone ● G-CSF, GM-CSF (granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor) Increased nephrotoxicity ● Amphotericin B ● Indomethacin: |
| Amphotericin b | drug interactions | … (granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor) Increased nephrotoxicity ● Amphotericin B ● Indomethacin: |
| Azathioprine | drug interactions | Acute water intoxication has been reported with concomitant use of indomethacin Increase in other toxicities: ● Azathioprine: |
| Busulfan | warnings and precautions | A cytoreductive regimen in preparation for bone marrow transplantation that consists of cyclophosphamide in combination with whole-body irradiation, busulfan, or other agents has been identified as a major risk factor. |
| Cyclosporine | drug interactions | Cyclosporine Concomitant administration of cyclophosphamide may decrease serum concentrations of cyclosporine. |
| Cytarabine | drug interactions | ACE inhibitors can cause leukopenia. ● Natalizumab ● Paclitaxel: Increased hematotoxicity has been reported when cyclophosphamide was administered after paclitaxel infusion. ● Thiazide diuretics ● Zidovudine Increased cardiotoxicity ● Anthracyclines ● Cytarabine ● Pentostatin ● Radiation therapy of the cardiac region … |
| Doxorubicin | drug interactions | Use of protease inhibitor-based regimens was found to be associated with a higher incidence of infections and neutropenia in patients receiving cyclophosphamide, doxorubicin, and etoposide (CDE) than use of a Non-Nucleoside Reverse Transcriptase Inhibitor-based regimen. |
| Etanercept | drug interactions | Cyclophosphamide on Other Drugs Etanercept A higher incidence of non-cutaneous malignant solid tumors in patients with Wegener’s granulomatosis occurred with the addition of etanercept to cyclophosphamide treatment. |
| Etoposide | drug interactions | Use of protease inhibitor-based regimens was found to be associated with a higher incidence of infections and neutropenia in patients receiving cyclophosphamide, doxorubicin, and etoposide (CDE) than use of a Non-Nucleoside Reverse Transcriptase Inhibitor-based regimen. |
| Indomethacin | drug interactions | … colony-stimulating factor, granulocyte macrophage colony-stimulating factor) Increased nephrotoxicity ● Amphotericin B ● Indomethacin: |
| Mesna | warnings and precautions | Mesna has been used to prevent severe bladder toxicity. |
| Metronidazole | drug interactions | Monitor for neurologic toxicities in patients receiving metronidazole. |
| Natalizumab | drug interactions | ACE inhibitors can cause leukopenia. ● Natalizumab ● Paclitaxel: Increased hematotoxicity has been reported when cyclophosphamide was administered after paclitaxel infusion. ● Thiazide diuretics ● Zidovudine Increased cardiotoxicity ● Anthracyclines ● Cytarabine ● Pentostatin ● Radiation therapy of the cardiac region … |
| Paclitaxel | drug interactions | ACE inhibitors can cause leukopenia. ● Natalizumab ● Paclitaxel: Increased hematotoxicity has been reported when cyclophosphamide was administered after paclitaxel infusion. ● Thiazide diuretics ● Zidovudine Increased cardiotoxicity ● Anthracyclines ● Cytarabine ● Pentostatin ● Radiation therapy of the cardiac region … |
Every other medicine the cyclophosphamide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Pentostatin | drug interactions | … Zidovudine Increased cardiotoxicity ● Anthracyclines ● Cytarabine ● Pentostatin ● Radiation therapy of the cardiac region ● Trastuzumab Increased pulmonary toxicity ● Amiodarone ● G-CSF, GM-CSF … |
| Succinylcholine | drug interactions | Prolonged apnea may occur with concurrent depolarizing muscle relaxants (e.g., succinylcholine). |
| Tamoxifen | drug interactions | Tamoxifen Concomitant use of tamoxifen and a cyclophosphamide-containing chemotherapy regimen may increase the risk of thromboembolic complications. |
| Trastuzumab | drug interactions | … Cytarabine ● Pentostatin ● Radiation therapy of the cardiac region ● Trastuzumab Increased pulmonary toxicity ● Amiodarone ● G-CSF, GM-CSF (granulocyte colony-stimulating factor, granulocyte … |
| Warfarin | drug interactions | Coumarins Both increased and decreased warfarin effect have been reported in patients receiving warfarin and cyclophosphamide. |
| Zidovudine | drug interactions | … was administered after paclitaxel infusion. ● Thiazide diuretics ● Zidovudine Increased cardiotoxicity ● Anthracyclines ● Cytarabine ● Pentostatin ● Radiation therapy of the cardiac region ● … |
Other labels that name cyclophosphamide
Source: FDA drug label (Cyclophosphamide), Amneal Pharmaceuticals LLC, effective January 19, 2026 (SPL set 520bfe39-dfd5-4a20-9a37-80078afded0d), via openFDA; the full label on DailyMed
What do FAERS reports show for cyclophosphamide?
The FDA Adverse Event Reporting System holds 176,005 reports that list cyclophosphamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 35,641 are coded as a death and 63,677 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 next?
- Other alkylating drugs
- the pharmacologic class, with prices and generics
- Cyclophosphamide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other