Medicine
Bendamustine 100 mg/20 mL powder for injection
Bendamustine 100 mg/20 mL powder for injection is a generic prescription medicine for intravenous use, made by 4 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Bendamustine hydrochloride for Injection, USP (25 mg/vial or 100 mg/vial…
Key facts
- Active ingredient (INN)
- Bendamustine
- Brand
- Sold under the generic name
- Strength
- 100 mg/20 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial and 4 more
- Manufacturers
- Accord HealthcareIndiaEugiaIndiaMeitheal PharmaceuticalsBluePoint Laboratories
- Origin register
- US FDA, United States
- Storage
- Bendamustine hydrochloride for Injection, USP (25 mg/vial or 100 mg/vial lyophilized powder) Bendamustine hydrochloride for Injection, USP may be stored up to 25°C (77°F) with excursions permitted up to 30°C (86°F). Retain in original package until time of use to protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01AA09 Bendamustine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 December 2022
- Identifiers
- RxCUI 1805001, 1805007DailyMed set ID 33867f0f-f317-1fd0-e054-00144ff8d46c, dbe34bc1-06b2-493f-8859-e8b143357aa8, 40f6f58d-d9ac-4f65-9fc7-16984bf1f180 +1NDC 16729-251, 55150-391, 71288-102 +4Application ANDA205574, ANDA214739, ANDA211001
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 16729-250-03 | Accord HealthcareIndia | 7 December 2022 |
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 16729-251-05 | Accord HealthcareIndia | 7 December 2022 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 55150-391-01 | EugiaIndia | 5 June 2023 |
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 55150-392-01 | EugiaIndia | 5 June 2023 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 71288-102-10 | Meitheal Pharmaceuticals | 5 June 2023 |
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 71288-103-20 | Meitheal Pharmaceuticals | 5 June 2023 |
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 68001-572-41 | BluePoint Laboratories | 15 October 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 20 March 2008 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Bendamustine 100 mg/20 mL powder for injection.
Other strengths and forms of Bendamustine
Clinical summary
Bendamustine is an alkylating drug indicated for treatment of patients with chronic lymphocytic leukemia (CLL), among other approved uses. It is available as powder for injection and injection for intravenous use. MedsAcross supplies Bendamustine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about BendamustineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TREANDA prescribing information (Cephalon) · U.S. National Library of Medicine, DailyMed
Need Bendamustine 100 mg/20 mL powder for injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.