Data / Drug companies / Bendamustine hydrochloride
Bendamustine hydrochloride: 10 companies and 15 products in the FDA NDC directory
Bendamustine hydrochloride is listed in the FDA National Drug Code Directory by 10 companies, with 15 products in commercial distribution. 5 of the products (33.3%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, powder, lyophilized, for solution; injection; injection, solution, and the newest product started marketing on September 25, 2026.
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- Companies listing it
- 10
- Products
- 15
- Generic (ANDA) products
- 5 (33.3%)
- Application numbers
- 9
- Routes
- Intravenous
- Brand names
- Vivimusta, Treanda, Gobarden, Bendeka, Belrapzo
- openFDA record search
- api.fda.gov
Companies that list bendamustine hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Cephalon, LLC | 3 | injection, powder, lyophilized, for solution; injection, solution | New drug applications (NDA) | December 8, 2015 |
| Accord Healthcare Inc. | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | December 7, 2022 |
| Avyxa Pharma, LLC | 2 | injection, solution; injection | New drug applications (NDA) | September 25, 2026 |
| Eugia US LLC | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | June 5, 2023 |
| Apotex Corp. | 1 | injection, solution | New drug applications (NDA) | April 26, 2023 |
| Azurity Pharmaceuticals, Inc. | 1 | injection | New drug applications (NDA) | April 1, 2025 |
| Baxter Healthcare Company | 1 | injection | New drug applications (NDA) | December 15, 2022 |
| BluePoint Laboratories | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | September 15, 2023 |
| Eagle Pharmaceuticals, Inc. | 1 | injection | New drug applications (NDA) | June 3, 2019 |
| Slayback Pharma LLC | 1 | injection | New drug applications (NDA) | December 7, 2022 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, powder, lyophilized, for solution | 7 | 46.7% |
| Injection | 5 | 33.3% |
| Injection, solution | 3 | 20% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| New drug applications (NDA) | 10 | 66.7% |
| Generic drugs (ANDA) | 5 | 33.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Alkylating Drug | 15 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.