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TREANDA

Bendamustine Hydrochloride · Injection, Powder, Lyophilized, for Solution

Prescription NDA TE AP RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
TREANDA
Generic name
Bendamustine Hydrochloride
Dosage form
Injection, Powder, Lyophilized, for Solution
Route
Intravenous
Marketing category
NDA · NDA
Labeler
Cephalon, LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Bendamustine Hydrochloride 100 mg/20mL 1726097 View
Bendamustine Hydrochloride 25 mg/5mL 1726097 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Powder, Lyophilized, for Solution
Route of administration
Intravenous
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Alkylating Activity [MoA] MoA All 23 members
Alkylating Drug [EPC] EPC All 23 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
022249
Application type
NDA · New Drug Application
Approval date
March 20, 2008
Sponsor
CEPHALON
Products on application
4
Submissions recorded
18
Products approved under application 022249.
Product Trade name Form Strength Ingredient Status TE Flags
022249-001 TREANDA POWDER BENDAMUSTINE HYDROCHLORIDE Prescription AP RLD RS
022249-002 TREANDA POWDER BENDAMUSTINE HYDROCHLORIDE Prescription AP RLD RS
022249-003 TREANDA SOLUTION BENDAMUSTINE HYDROCHLORIDE Discontinued — RLD
022249-004 TREANDA SOLUTION BENDAMUSTINE HYDROCHLORIDE Discontinued — RLD

Therapeutic equivalence

Source: Orange Book
TE code
AP
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (parenteral aqueous solutions)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8791270 January 12, 2026 001 No U-1542 July 29, 2014
8609863 January 12, 2026 001 No January 16, 2014
8895756 January 12, 2026 001 No November 26, 2014
8791270 January 12, 2026 002 No U-1542 July 29, 2014
8895756 January 12, 2026 002 No November 26, 2014
8609863 January 12, 2026 002 No January 16, 2014
8791270 January 12, 2026 003 No U-1542 December 9, 2014
8791270 January 12, 2026 004 No U-1542 December 9, 2014
8791270*PED July 12, 2026 001 No —
8609863*PED July 12, 2026 001 No —
8895756*PED July 12, 2026 001 No —
8791270*PED July 12, 2026 002 No —
8609863*PED July 12, 2026 002 No —
8895756*PED July 12, 2026 002 No —
8791270*PED July 12, 2026 003 No —
8791270*PED July 12, 2026 004 No —
8883836 March 26, 2029 001 No U-1402 November 13, 2014
9533955 March 26, 2029 001 No U-1952 —
8445524 March 26, 2029 001 Yes U-1402 June 4, 2013
9533955 March 26, 2029 001 No U-1949 —
8669279 March 26, 2029 001 No U-1402 October 30, 2014
8445524 March 26, 2029 002 Yes U-1402 June 4, 2013
9533955 March 26, 2029 002 No U-1952 January 13, 2017
8669279 March 26, 2029 002 No U-1402 October 30, 2014
9533955 March 26, 2029 002 No U-1949 January 13, 2017
8883836 March 26, 2029 002 No U-1402 November 13, 2014
8445524 March 26, 2029 003 Yes September 17, 2013
8445524 March 26, 2029 004 Yes September 17, 2013
8344006 September 23, 2029 003 No U-1402 —
8344006 September 23, 2029 004 No U-1402 —
8445524*PED September 26, 2029 001 No —
8883836*PED September 26, 2029 001 No —
8669279*PED September 26, 2029 001 No —
9533955*PED September 26, 2029 001 No —
8445524*PED September 26, 2029 002 No —
8883836*PED September 26, 2029 002 No —
8669279*PED September 26, 2029 002 No —
9533955*PED September 26, 2029 002 No —
8445524*PED September 26, 2029 003 No —
8445524*PED September 26, 2029 004 No —
8344006*PED March 23, 2030 003 No —
8344006*PED March 23, 2030 004 No —
8436190 October 26, 2030 001 No June 4, 2013
8436190 October 26, 2030 002 No June 4, 2013
8436190*PED April 26, 2031 001 No —
8436190*PED April 26, 2031 002 No —

Approval history

Source: Drugs@FDA
Most recent submissions on application 022249.
Type No. Action Status Date Review
Supplement 26 Labeling Approved October 25, 2022 Standard
Supplement 25 Labeling Approved June 10, 2021 Standard
Supplement 24 Labeling Approved November 21, 2019 Standard
Supplement 23 Labeling Approved December 15, 2017 Standard
Supplement 22 Labeling Approved October 18, 2016 Standard
Supplement 20 Labeling Approved November 5, 2015 Standard
Supplement 21 Labeling Approved September 2, 2015 Standard
Supplement 18 Manufacturing (CMC) Approved July 8, 2015 Priority
Supplement 19 Labeling Approved March 10, 2015 Standard
Supplement 17 Manufacturing (CMC) Approved March 27, 2014 Priority
Supplement 15 Manufacturing (CMC) Approved September 13, 2013 Priority
Supplement 14 Labeling Approved August 28, 2013 Standard
Supplement 12 Labeling Approved June 26, 2012 Standard
Supplement 6 Labeling Approved December 21, 2010 Unknown
Supplement 5 Labeling Approved February 26, 2010 901 Required
Supplement 1 Manufacturing (CMC) Approved May 1, 2009 N/A
Supplement 2 Labeling Approved April 22, 2009 Standard
Original application 1 Type 1 - New Molecular Entity Approved March 20, 2008 Priority

Review documents

  • 0 · Supplement · November 3, 2022
  • 0 · Supplement · October 27, 2022
  • 0 · Supplement · June 14, 2021
  • 0 · Supplement · June 11, 2021
  • 0 · Supplement · May 8, 2020
  • 0 · Supplement · November 22, 2019
  • 0 · Supplement · November 22, 2019
  • 0 · Supplement · December 22, 2017
  • 0 · Supplement · December 20, 2017
  • 0 · Supplement · October 20, 2016
  • 0 · Supplement · October 19, 2016
  • 0 · Supplement · July 27, 2016
  • 0 · Supplement · July 27, 2016
  • 0 · Supplement · November 12, 2015
  • 0 · Supplement · November 9, 2015
  • 0 · Supplement · September 4, 2015
  • 0 · Supplement · September 2, 2015
  • 0 · Supplement · March 11, 2015
  • 0 · Supplement · March 10, 2015
  • 0 · Supplement · August 1, 2014
  • 0 · Supplement · September 17, 2013
  • 0 · Supplement · August 29, 2013
  • 0 · Supplement · August 29, 2013
  • 0 · Supplement · June 27, 2012
  • 0 · Supplement · June 27, 2012
  • 0 · Supplement · July 7, 2011
  • 0 · Supplement · December 28, 2010
  • 0 · Supplement · December 26, 2010
  • 0 · Supplement · March 4, 2010
  • 0 · Supplement · March 3, 2010

Adverse event reports

Source: openFDA FAERS
11,906
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: BENDAMUSTINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
63459-390-08 63459-390 Cephalon, LLC 1 VIAL, SINGLE-DOSE in 1 CARTON (63459-390-08) / 5 mL in 1 VIAL, SINGLE-DOSE January 5, 2010
63459-391-20 63459-391 Cephalon, LLC 1 VIAL, SINGLE-DOSE in 1 CARTON (63459-391-20) / 20 mL in 1 VIAL, SINGLE-DOSE March 31, 2008
63459-390 63459-390 Cephalon, LLC — January 5, 2010
63459-391 63459-391 Cephalon, LLC — March 31, 2008

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.