Quick answers
- What is Bendamustine hydrochloride used for?
- The FDA-approved label (Vivimusta, Azurity Pharmaceuticals, Inc., April 3, 2025) says: “VIVIMUSTA is an alkylating drug indicated for treatment of patients with: • Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bendamustine hydrochloride have a boxed warning?
- No. None of the 11 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Bendamustine hydrochloride?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated July 23, 2026). Ask your pharmacist about alternatives.
- Has Bendamustine hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started August 14, 2023 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Bendamustine hydrochloride?
- 12 companies list prescription products of Bendamustine hydrochloride in the FDA NDC Directory, including Cephalon, LLC, Avyxa Pharma, LLC and Eugia US LLC.
What Bendamustine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VIVIMUSTA is an alkylating drug indicated for treatment of patients with: • Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. …
— FDA label: Vivimusta, Azurity Pharmaceuticals, Inc., effective April 3, 2025. Read the full label on DailyMed →
The FDA has 11 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 11 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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.
- Cephalon, LLC2 products
- Avyxa Pharma, LLC2 products
- Eugia US LLC2 products
- Meitheal Pharmaceuticals Inc.2 products
- Accord Healthcare Inc.2 products
- BluePoint Laboratories1 product
- Eagle Pharmaceuticals, Inc.1 product
- Baxter Healthcare Corporation1 product
- Azurity Pharmaceuticals, Inc.1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Slayback Pharma LLC1 product
- Apotex Corp.1 product
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 |
|---|---|---|---|
| NDA022249 TREANDA | Cephalon | March 20, 2008 | 17, latest October 25, 2022 2022: Labeling · 2021: Labeling · 2019: Labeling |
| NDA205580 BELRAPZO | Eagle Pharms | May 15, 2018 | 5, latest January 11, 2024 2024: Labeling · 2022: Labeling · 2021: Labeling |
| NDA208194 BENDEKA | Eagle Pharms | December 7, 2015 | 10, latest January 11, 2024 2024: Labeling · 2021: Labeling · 2019: Labeling |
| NDA212209 VIVIMUSTA | Azurity | December 7, 2022 | 3, latest February 27, 2024 2024: Labeling · 2024: Labeling · 2023: Labeling |
| NDA215033 BENDAMUSTINE HYDROCHLORIDE | Apotex | December 7, 2022 | 1, latest April 15, 2024 2024: Labeling |
| NDA216078 BENDAMUSTINE HYDROCHLORIDE | Baxter Hlthcare Corp | December 15, 2022 | 1, latest February 26, 2024 2024: Labeling |
| NDA219014 GOBARDEN | Avyxa Holdings | July 3, 2025 | 1, latest September 25, 2026 2026: Labeling |
Generic approvals (3)
- ANDA205574Accord Hlthcare · December 7, 2022
- ANDA211001Meitheal · June 5, 2023
- ANDA214739Eugia Pharma · June 5, 2023
Shortage status
To be discontinued · updated July 23, 2026 · first posted July 23, 2026
| Product | Treanda, Injection, Solution, 25 mg/5 mL, 1 vial, Single-Dose in 1 carton (NDC 63459-390-08) |
|---|---|
| Company | Cephalon, LLC (a wholly owned subsidiary of Teva Pharmaceutical Industries, Ltd.) |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
August 14, 2023 · Class III · Completed · D-1103-2023
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01. — Baxter Healthcare Corporation
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Vivimusta, Azurity Pharmaceuticals, Inc., effective April 3, 2025; 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 →