Active ingredient
Bendamustine
16 finished FDA listings contain Bendamustine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BENDAMUSTINE HYDROCHLORIDE
- Dosage forms
- Injection, Injection, Powder, Lyophilized, For Solution, Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 12
- Strengths listed
- 100 mg/1 · 100 mg/20ml · 100 mg/4ml · 25 mg/5ml · 25 mg/ml
- Brand names in FDA listings
- Belrapzo, Bendamustine, Bendeka, Treanda, Vivimusta
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 134547
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 022249 | CEPHALON | 2008-03-20 | 2 |
| NDA 208194 | EAGLE PHARMS | 2015-12-07 | 1 |
| NDA 205580 | EAGLE PHARMS | 2018-05-15 | 1 |
| ANDA 205574 | ACCORD HLTHCARE | 2022-12-07 | 3 |
| NDA 212209 | AZURITY | 2022-12-07 | 2 |
| NDA 215033 | APOTEX | 2022-12-07 | 1 |
| NDA 216078 | BAXTER HLTHCARE CORP | 2022-12-15 | 1 |
| ANDA 214739 | EUGIA PHARMA | 2023-06-05 | 2 |
| ANDA 211001 | MEITHEAL | 2023-06-05 | 2 |
| NDA 219014 | AVYXA HOLDINGS | 2025-07-03 | 1 |
Official labeling on DailyMed
- BENDAMUSTINE HYDROCHLORIDE INJECTION, SOLUTION [APOTEX CORP] · version 9 · 2026-09-10
- BENDAMUSTINE HYDROCHLORIDE INJECTION [AVYXA PHARMA, LLC] · version 1 · 2026-05-29
- BENDAMUSTINE (BENDAMUSTINE HCL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION BENDAMUSTINE (BENDAMUSTINE HCL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 10 · 2026-05-20
- BENDAMUSTINE HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION] · version 11 · 2026-04-17
- VIVIMUSTA (BENDAMUSTINE HYDROCHLORIDE) INJECTION [AZURITY PHARMACEUTICALS, INC.] · version 2 · 2025-04-07
- BELRAPZO (BENDAMUSTINE HYDROCHLORIDE) INJECTION [EAGLE PHARMACEUTICALS, INC] · version 11 · 2024-10-03
- VIVIMUSTA (BENDAMUSTINE HYDROCHLORIDE) INJECTION [SLAYBACK PHARMA LLC] · version 22 · 2024-09-25
- BENDAMUSTINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.] · version 6 · 2024-07-19
- BENDAMUSTINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BLUEPOINT LABORATORIES] · version 3 · 2024-04-01
- BENDEKA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION [TEVA PHARMACEUTICALS USA, INC.] · version 22 · 2024-01-24
- BENDAMUSTINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] · version 2 · 2023-07-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.