Quick answers
- What is Cyclophosphamide used for?
- The FDA-approved label (Frindovyx, AVYXA Pharma, LLC, August 26, 2026) says: “Malignant Diseases FRINDOVYX is indicated for the treatment of adult and pediatric patients with: malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma Burkitt's lymphoma multiple myeloma leukemias …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cyclophosphamide have a boxed warning?
- No. None of the 31 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cyclophosphamide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cyclophosphamide been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 5, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Cyclophosphamide?
- 25 companies list prescription products of Cyclophosphamide in the FDA NDC Directory, including Baxter Healthcare Company, BluePoint Laboratories and Avyxa Pharma, LLC.
What Cyclophosphamide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Malignant Diseases FRINDOVYX is indicated for the treatment of adult and pediatric patients with: malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma Burkitt's lymphoma multiple myeloma leukemias …
— FDA label: Frindovyx, AVYXA Pharma, LLC, effective August 26, 2026. Read the full label on DailyMed →
The FDA has 31 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 31 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution · Injection · Capsule · Injection, powder, lyophilized, for solution · Injection, solution · Injection, solution, concentrate · Tablet |
|---|---|
| Route | Intravenous · Oral |
| Prescription products | 90 in the FDA NDC Directory |
| Brand names | Frindovyx |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| cyclophosphamide 25 mg capsule | Generic | $1.15 per capsule |
| cyclophosphamide 50 mg capsule | Generic | $1.79 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Baxter Healthcare Company14 products
- BluePoint Laboratories8 products
- Avyxa Pharma, LLC6 products
- Sandoz Inc6 products
- Avenacy, LLC3 products
- XGen Pharmaceuticals DJB, Inc.3 products
- Eugia US LLC3 products
- Bamboo US Bidco LCC3 products
- Hainan Poly Pharm. Co., Ltd.3 products
- NorthStar Rx LLC3 products
- Slate Run Pharmaceuticals, LLC3 products
- Hisun Pharmaceuticals USA, Inc.3 products
- Epic Pharma, LLC3 products
- Sagent Pharmaceuticals3 products
- Fresenius Kabi USA, LLC3 products
- Civica, Inc.3 products
- Amneal Pharmaceuticals LLC3 products
- Dr. Reddy's Labratories Inc.3 products
- Nexus Pharmaceuticals LLC2 products
- Cipla USA Inc.2 products
- Alembic Pharmaceuticals Inc.2 products
- Hikma Pharmaceuticals USA Inc.2 products
- OPKO Pharmaceuticals, LLC2 products
- Baxter Healthcare Corporation2 products
- Alembic Pharmaceuticals Limited2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA012141 CYTOXAN | Baxter Hlthcare | November 16, 1959 | 47, latest August 7, 2020 2020: Manufacturing (CMC) · 2013: Labeling · 2012: Labeling |
| NDA203856 CYCLOPHOSPHAMIDE | Hikma | September 16, 2013 | 1, latest September 26, 2019 2019: Labeling |
| NDA210735 CYCLOPHOSPHAMIDE | Eugia Pharma Speclts | August 25, 2021 | 1, latest November 20, 2023 2023: Labeling |
| NDA210852 FRINDOVYX | Avyxa Holdings | June 7, 2023 | 2, latest August 1, 2025 2025: Labeling · 2025: Labeling |
| NDA212501 CYCLOPHOSPHAMIDE | DR Reddys | July 30, 2020 | 3, latest March 11, 2025 2025: Labeling · 2021: Manufacturing (CMC) · 2021: Labeling |
| NDA217150 CYCLOPHOSPHAMIDE | Sandoz | September 12, 2023 | 1, latest December 30, 2024 2024: Labeling |
| NDA217651 CYCLOPHOSPHAMIDE | Baxter Hlthcare Corp | June 27, 2023 | — |
Generic approvals (11)
- ANDA040745Baxter Hlthcare · May 21, 2008
- ANDA204555Hengrui Pharma · October 31, 2014
- ANDA210046Amneal · May 25, 2018
- ANDA211608Cipla · January 18, 2019
- ANDA211757Xgen Pharms · October 18, 2022
- ANDA215892Alembic · November 10, 2022
- ANDA214529Sagent Pharms Inc · July 17, 2023
- ANDA216783Nexus · October 29, 2024
- ANDA218282Eirgen · December 3, 2024
- ANDA218644Epic Pharma LLC · December 19, 2024
- ANDA218632Hainan Poly · December 26, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 5, 2025 · Class II · Ongoing · D-0651-2025
cGMP deviations: Temperature excursion during transportation.
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial N — Sandoz Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 197549, 197550, 1437968, 1437969, 1734917, 1734919, 1734921, 2386859, 2568661, 2568663 … (+6) |
|---|---|
| SPL set ID of the quoted label | 5ad8ea65-4c98-487a-9c8d-df778765ec5e |
| FDA labels (SPL) | 31 |
| FDA applications | NDA012141, NDA203856, NDA210735, NDA210852, NDA212501, NDA217150, NDA217651, 11 ANDA |
| Active ingredients (FDA) | CYCLOPHOSPHAMIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Frindovyx, AVYXA Pharma, LLC, effective August 26, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →