FDA.reportPublic FDA data

bendamustine hydrochloride 100 MG Injection

RxCUI
1805001
RxNorm name
bendamustine hydrochloride 100 MG Injection
Display name
Bendamustine (Injectable)
Full name
bendamustine hydrochloride 100 MG Injection
Term type
SCD
Status
Active
Strength
100 mg
Dose form
Injection
Route
Injectable
Updated
2026-10-24 12:46:40

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092016
Active start
092016
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
bendamustine hydrochloride100 MG / 1 EACHbendamustinebendamustine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Injection1649574

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
bendamustine134547

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRbendamustine hydrochloride 100 MG Injection1NAMES
RxNorm Namebendamustine hydrochloride 100 MG Injection1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
4 linked values
4CODES
RxCUI18050011CODES
MMSL_CODEBD234281CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
16729-251-0516729-251bendamustine hydrochloride bendamustine hydrochlorideAccord Healthcare, Inc.ANDA205574
55150-392-0155150-392BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDEEugia US LLCANDA214739
68001-572-4168001-572bendamustine hydrochloride bendamustine hydrochlorideBluePoint LaboratoriesANDA205574
71288-103-2071288-103Bendamustine Bendamustine HClMeitheal Pharmaceuticals Inc.ANDA211001

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA20557416729-251bendamustine hydrochloride bendamustine hydrochlorideANDAAccord Healthcare, Inc.
ANDA21473955150-392BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDEANDAEugia US LLC
ANDA21100171288-103Bendamustine Bendamustine HClANDAMeitheal Pharmaceuticals Inc.

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
16729025105rxnav_ndcsyes
55150039201rxnav_ndcsyes
60505609600rxnav_ndcsyes
68001057241rxnav_ndcsyes
71288010320rxnav_ndcsyes
67457032605rxnav_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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BendamustineBENDAMUSTINE HCLMeitheal Pharmaceuticals Inc.40f6f58d-d9ac-4f65-9fc7-16984bf1f1802026-05-11Warnings, Adverse reactionsExact identifier
ndc (package): 71288-103-20
ndc (product): 71288-103
ndc11 (package): 71288010320
rxcui: 1805001
bendamustine hydrochlorideBENDAMUSTINE HYDROCHLORIDEAccord Healthcare, Inc.33867f0f-f317-1fd0-e054-00144ff8d46c2024-07-18Warnings, Adverse reactionsExact identifier
ndc (package): 16729-251-05
ndc (product): 16729-251
ndc11 (package): 16729025105
rxcui: 1805001
bendamustine hydrochlorideBENDAMUSTINE HYDROCHLORIDEBluePoint Laboratories0df025d2-c093-427a-b599-f605e71fe8352024-03-29Warnings, Adverse reactionsExact identifier
ndc (package): 68001-572-41
ndc (product): 68001-572
ndc11 (package): 68001057241
rxcui: 1805001
BENDAMUSTINE HYDROCHLORIDEBENDAMUSTINE HYDROCHLORIDEEugia US LLCdbe34bc1-06b2-493f-8859-e8b143357aa82023-07-05Warnings, Adverse reactionsExact identifier
ndc (package): 55150-392-01
ndc (product): 55150-392
ndc11 (package): 55150039201
rxcui: 1805001

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 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
39d53698-57fa-7c99-fc5b-f52a55684826bendamustine HCl 100 MG Injection [PSN] · bendamustine hydrochloride 100 MG Injection [SCD]226These highlights do not include all the information needed to use TREANDA safely and effectively. See full prescribing information for TREANDA. TREANDA ® (bendamustine hydrochloride) injection, for intravenous use TREANDA ® (bendamustine hydrochloride) for injection, for intravenous use Initial U.S. Approval: 200820221027
40f6f58d-d9ac-4f65-9fc7-16984bf1f180bendamustine HCl 100 MG Injection [PSN] · bendamustine hydrochloride 100 MG Injection [SCD]210These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 200820260511
33867f0f-f317-1fd0-e054-00144ff8d46cbendamustine HCl 100 MG Injection [PSN] · bendamustine hydrochloride 100 MG Injection [SCD]26These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for Injection, for intravenous use Initial U.S. Approval: 200820240718
0df025d2-c093-427a-b599-f605e71fe835bendamustine HCl 100 MG Injection [PSN] · bendamustine hydrochloride 100 MG Injection [SCD]23These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for Injection, for intravenous use Initial U.S. Approval: 200820240329
dbe34bc1-06b2-493f-8859-e8b143357aa8bendamustine HCl 100 MG Injection [PSN] · bendamustine hydrochloride 100 MG Injection [SCD]22These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 200820230705

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
40f6f58d-d9ac-4f65-9fc7-16984bf1f180These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 2008Meitheal Pharmaceuticals Inc.20260511
5de3a3b3-7acd-7f0b-ecc4-60d544484149These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 2008Apotex Corp | Apotex Inc | Gland Pharma Limited20241113
33867f0f-f317-1fd0-e054-00144ff8d46cThese highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for Injection, for intravenous use Initial U.S. Approval: 2008Accord Healthcare, Inc. | Intas Pharmaceuticals Limited20240718
0df025d2-c093-427a-b599-f605e71fe835These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for Injection, for intravenous use Initial U.S. Approval: 2008BluePoint Laboratories | Intas Pharmaceuticals Limited20240329
dbe34bc1-06b2-493f-8859-e8b143357aa8These highlights do not include all the information needed to use BENDAMUSTINE HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for BENDAMUSTINE HYDROCHLORIDE FOR INJECTION. BENDAMUSTINE HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 2008Eugia US LLC | EUGIA Pharma Specialities Limited20230705

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_STRENGTH100 MG (expressed as bendamustine hydrochloride)
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA205574
CODESANDAANDA211001
CODESANDAANDA214739
CODESSNOMEDCT785134008
CODESVUID4027300
NAMESPrescribable Synonymbendamustine HCl 100 MG Injection
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceUS Edition of SNOMED_CT
SOURCESSourceVeterans Health Administration National Drug File