FDA.reportPublic FDA data

bendamustine hydrochloride 25 MG/ML Injectable Solution

RxCUI
1726097
RxNorm name
bendamustine hydrochloride 25 MG/ML Injectable Solution
Display name
Bendamustine (Injectable)
Full name
bendamustine hydrochloride 25 MG/ML Injectable Solution
Term type
SCD
Status
Active
Strength
25 mg/ml
Dose form
Sol
Route
Injectable
Updated
2026-10-21 00:30:37

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012016
Active start
012016
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
bendamustine hydrochloride25 MG / 1 MLbendamustinebendamustine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Injectable Solution316949

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
bendamustine134547

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRbendamustine hydrochloride 25 MG/ML Injectable Solution1NAMES
RxNorm Namebendamustine hydrochloride 25 MG/ML Injectable Solution1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI17260971CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
10019-079-0110019-079BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochlorideBaxter Healthcare CorporationNDA216078
60505-6228-060505-6228Bendamustine Hydrochloride Bendamustine HydrochlorideApotex CorpNDA215033
83831-183-0483831-183BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochlorideAvyxa Pharma, LLCNDA219014

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA21607810019-079BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochlorideNDABaxter Healthcare Corporation
NDA21503360505-6228Bendamustine Hydrochloride Bendamustine HydrochlorideNDAApotex Corp
NDA21901483831-183BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochlorideNDAAvyxa Pharma, LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 6 matching rows.

NDC11, Source, Active table
NDC11SourceActive
10019007901rxnav_ndcsyes
60505622800rxnav_ndcsyes
83831018304rxnav_ndcsyes
42367052025rxnav_historical
42367052125rxnav_historical
83703053301rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bendamustine HydrochlorideBENDAMUSTINE HYDROCHLORIDEApotex Corp085dd54c-4212-d879-afef-ee52732a48c02026-09-09Warnings, Adverse reactionsExact identifier
ndc (package): 60505-6228-0
ndc (product): 60505-6228
ndc11 (package): 60505622800
rxcui: 1726097
BENDAMUSTINE HYDROCHLORIDEBENDAMUSTINE HYDROCHLORIDEAvyxa Pharma, LLCf359e7c6-d104-457d-a7fe-597c744403532026-05-14Warnings, Adverse reactionsExact identifier
ndc (package): 83831-183-04
ndc (product): 83831-183
ndc11 (package): 83831018304
rxcui: 1726097
VIVIMUSTABENDAMUSTINE HYDROCHLORIDEAzurity Pharmaceuticals, Inc.4df6548f-c4ad-4eb2-a54f-19766a3d90ca2025-04-03Warnings, Adverse reactionsExact identifier
rxcui: 1726097
BENDAMUSTINE HYDROCHLORIDEBENDAMUSTINE HYDROCHLORIDEBaxter Healthcare Corporation766b73e2-49bb-47f9-bbb1-44cfa1a3197e2025-02-10Warnings, Adverse reactionsExact identifier
ndc (package): 10019-079-01
ndc (product): 10019-079
ndc11 (package): 10019007901
rxcui: 1726097
BELRAPZOBENDAMUSTINE HYDROCHLORIDEEagle Pharmaceuticals, Inc9759a4ae-82ca-40cf-9c02-e1cadb21cbdc2024-09-23Warnings, Adverse reactionsExact identifier
ndc11 (package): 42367052125
rxcui: 1726097
VIVIMUSTABENDAMUSTINE HYDROCHLORIDESlayback Pharma LLCcbcc6eb7-aa62-4599-af49-05203fedb4bb2024-02-27Warnings, Adverse reactionsExact identifier
rxcui: 1726097
BendekaBENDAMUSTINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.ace9a43b-f9bd-4896-abfe-0ef4fec67ddf2024-01-19Warnings, Adverse reactionsExact identifier
rxcui: 1726097

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 7 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
cbcc6eb7-aa62-4599-af49-05203fedb4bbbendamustine HCl 25 MG/ML Injectable Solution [PSN] · bendamustine hydrochloride 25 MG/ML Injectable Solution [SCD]222These highlights do not include all the information needed to use VIVIMUSTA safely and effectively. See full prescribing information for VIVIMUSTA. VIVIMUSTA® (bendamustine hydrochloride injection), for intravenous use. Initial U.S. Approval: 200820240227
ace9a43b-f9bd-4896-abfe-0ef4fec67ddfbendamustine HCl 25 MG/ML Injectable Solution [PSN] · bendamustine hydrochloride 25 MG/ML Injectable Solution [SCD]222These highlights do not include all the information needed to use BENDEKA safely and effectively. See full prescribing information for BENDEKA. BENDEKA ® (bendamustine hydrochloride injection), for intravenous use Initial U.S. Approval: 200820240119
766b73e2-49bb-47f9-bbb1-44cfa1a3197ebendamustine HCl 25 MG/ML Injectable Solution [PSN] · bendamustine hydrochloride 25 MG/ML Injectable Solution [SCD]211These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE INJECTION. BENDAMUSTINE HYDROCHLORIDE injection, for intravenous use. Initial U.S. Approval: 200820250210
9759a4ae-82ca-40cf-9c02-e1cadb21cbdcbendamustine HCl 25 MG/ML Injectable Solution [PSN] · bendamustine hydrochloride 25 MG/ML Injectable Solution [SCD]211These highlights do not include all the information needed to use BELRAPZO safely and effectively. See full prescribing information for BELRAPZO. BELRAPZO ® (bendamustine hydrochloride injection), for intravenous use. Initial U.S. Approval: 200820240923
085dd54c-4212-d879-afef-ee52732a48c0bendamustine HCl 25 MG/ML Injectable Solution [PSN] · bendamustine hydrochloride 25 MG/ML Injectable Solution [SCD]28These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE INJECTION. BENDAMUSTINE HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 200820250916
4df6548f-c4ad-4eb2-a54f-19766a3d90cabendamustine HCl 25 MG/ML Injectable Solution [PSN] · bendamustine hydrochloride 25 MG/ML Injectable Solution [SCD]22These highlights do not include all the information needed to use VIVIMUSTA safely and effectively. See full prescribing information for VIVIMUSTA. VIVIMUSTA® (bendamustine hydrochloride injection), for intravenous use. Initial U.S. Approval: 200820250403
f359e7c6-d104-457d-a7fe-597c74440353bendamustine HCl 25 MG/ML Injectable Solution [PSN] · bendamustine hydrochloride 25 MG/ML Injectable Solution [SCD]21These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE INJECTION. BENDAMUSTINE HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 200820260514

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
085dd54c-4212-d879-afef-ee52732a48c0These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE INJECTION. BENDAMUSTINE HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2008Apotex Corp | Apotex Inc20260909
f359e7c6-d104-457d-a7fe-597c74440353These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE INJECTION. BENDAMUSTINE HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2008Avyxa Pharma, LLC | Avyxa Holdings, LLC.20260514
085dd54c-4212-d879-afef-ee52732a48c0These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE INJECTION. BENDAMUSTINE HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 2008Apotex Corp | Apotex Inc20250916
766b73e2-49bb-47f9-bbb1-44cfa1a3197eThese highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE INJECTION. BENDAMUSTINE HYDROCHLORIDE injection, for intravenous use. Initial U.S. Approval: 2008Baxter Healthcare Corporation | Baxter Deutschland GmbH20250210
766b73e2-49bb-47f9-bbb1-44cfa1a3197eThese highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE INJECTION. BENDAMUSTINE HYDROCHLORIDE injection, for intravenous use. Initial U.S. Approval: 2008Baxter Healthcare Corporation | Baxter Deutschland GmbH20250210
9759a4ae-82ca-40cf-9c02-e1cadb21cbdcThese highlights do not include all the information needed to use BELRAPZO safely and effectively. See full prescribing information for BELRAPZO. BELRAPZO ® (bendamustine hydrochloride injection), for intravenous use. Initial U.S. Approval: 2008Eagle Pharmaceuticals, Inc20240923
1b52742e-2d24-bd00-e063-6294a90a5bd0These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE INJECTION. BENDAMUSTINE HYDROCHLORIDE injection, for intravenous use. Initial U.S. Approval: 2008Bamboo US Bidco LCC20240620
864f1c02-761f-4049-89fa-7aeec4118226These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE INJECTION. BENDAMUSTINE HYDROCHLORIDE INJECTION, for intravenous use. Initial U.S. Approval: 2008Eagle Pharmaceuticals, Inc20190508

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCL01AANitrogen mustard analoguesATC1-4bendamustine
FDASPLN0000175558Alkylating DrugEPChas_epcbendamustine
FDASPLN0000000236Alkylating ActivityMOAhas_moabendamustine
MEDRTD000069461Bendamustine HydrochlorideCHEMhas_ingredientbendamustine hydrochloride
MEDRTD000069461Bendamustine HydrochlorideCHEMhas_ingredientbendamustine
MEDRTD004342Drug HypersensitivityDISEASEci_withbendamustine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withbendamustine
MEDRTD007945Leukemia, LymphoidDISEASEmay_treatbendamustine hydrochloride
MEDRTD007945Leukemia, LymphoidDISEASEmay_treatbendamustine
MEDRTD008228Lymphoma, Non-HodgkinDISEASEmay_treatbendamustine hydrochloride
MEDRTD008228Lymphoma, Non-HodgkinDISEASEmay_treatbendamustine
MEDRTN0000000236Alkylating ActivityMOAhas_moabendamustine hydrochloride
MEDRTN0000000236Alkylating ActivityMOAhas_moabendamustine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH25 MG/ML (expressed as bendamustine hydrochloride)
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA215033
CODESNDANDA216078
CODESNDANDA219014
CODESVUID4035609
NAMESPrescribable Synonymbendamustine HCl 25 MG/ML Injectable Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File