FDA.reportPublic FDA data

bendamustine hydrochloride 100 MG Injection [Treanda]

RxCUI
1805004
RxNorm name
bendamustine hydrochloride 100 MG Injection [Treanda]
Display name
TREANDA (Injectable)
Full name
bendamustine hydrochloride 100 MG Injection [Treanda]
Term type
SBD
Status
Active
Strength
100 mg
Dose form
Injection
Route
Injectable
Updated
2026-10-24 12:46:45

RxNorm Status History#

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

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_STRTreanda 100 MG Injection1NAMES
RxNorm Namebendamustine hydrochloride 100 MG Injection [Treanda]1NAMES
RxNorm SynonymTreanda 100 MG Injection1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID39d53698-57fa-7c99-fc5b-f52a556848261CODES
RxCUI18050041CODES
MMSL_CODEBD234281CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
63459-391-2063459-391TREANDA Bendamustine HydrochlorideCephalon, LLCNDA022249

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA02224963459-391TREANDA Bendamustine HydrochlorideNDACephalon, LLC

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
63459039120rxnav_ndcsyes

UNII Substances#

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

No records found.

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
39d53698-57fa-7c99-fc5b-f52a55684826TREANDA 100 MG Injection [PSN] · bendamustine hydrochloride 100 MG Injection [Treanda] [SBD] · Treanda 100 MG Injection [SY]326These 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

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
39d53698-57fa-7c99-fc5b-f52a55684826These 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: 2008Cephalon, LLC20221031
39d53698-57fa-7c99-fc5b-f52a55684826These 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: 2008Cephalon, LLC20221027
ae9652c3-0f12-440e-9b77-4035ea016e57National Council for Prescription Drug Programs20120724

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
CODESNDANDA022249
NAMESPrescribable SynonymTREANDA 100 MG Injection
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon