FDA.reportPublic FDA data

BENDAMUSTINE HYDROCHLORIDE

Product NDC
83831-183
11-digit product format
838310183
Labeler code
83831
Product ID
83831-183_6c0bc00a-dd5f-4305-85d6-bd534e947e32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bendamustine hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Avyxa Pharma, LLC
Application
NDA219014
Marketing category
NDA
Marketing start
2026-05-29
Substance
BENDAMUSTINE HYDROCHLORIDE
Active strength
100 mg/4mL
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219014-001BENDAMUSTINE HYDROCHLORIDEBENDAMUSTINE HYDROCHLORIDE100MG/4ML (25MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N219014-001BENDAMUSTINE HYDROCHLORIDE100MG/4ML (25MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-0384e616aacf4f…
2026-08-18 06:07:402026-07N219014-001BENDAMUSTINE HYDROCHLORIDE100MG/4ML (25MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219014-001BENDAMUSTINE HYDROCHLORIDE100MG/4ML (25MG/ML)SOLUTION / INTRAVENOUSRLD2025-07-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219014-001BENDAMUSTINE HYDROCHLORIDE100MG/4ML (25MG/ML)SOLUTION / INTRAVENOUSRLD2025-07-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N219014-001BENDAMUSTINE HYDROCHLORIDE100MG/4ML (25MG/ML)SOLUTION / INTRAVENOUSRLD2025-07-036a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219014-001BENDAMUSTINE HYDROCHLORIDE100MG/4ML (25MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-03a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
BENDAMUSTINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENDAMUSTINE HYDROCHLORIDE100 mg/4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
981Y8SX18MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1726097Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f359e7c6-d104-457d-a7fe-597c74440353Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d8a9046a-cb9e-4038-9878-7314b52d6527Product name120230919
dd915fc1-21b5-4853-a27d-6a309d663ab6Product name120230913
188c28c4-6cdd-493c-850f-0529f5e5dd03Product name120230912
c9aaa656-9de9-4780-9592-b48e28af9e6eProduct name120180723
c2696876-93f7-42b5-907d-853b57a286f7Product name520180626
7dce4968-39c1-46ed-87ca-cce62b5b5728Product name120151215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83831-183-04BENDAMUSTINE HYDROCHLORIDE4 mL in 1 VIALINJECTION41
83831-183-04BENDAMUSTINE HYDROCHLORIDE1 in 1 CARTONINJECTION11

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENDAMUSTINE HYDROCHLORIDEBENDAMUSTINE HYDROCHLORIDEAvyxa Pharma, LLCf359e7c6-d104-457d-a7fe-597c744403532026-05-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 219014
application number: NDA219014
ndc (product): 83831-183

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726097bendamustine HCl 25 MG/ML Injectable SolutionPSNf359e7c6-d104-457d-a7fe-597c744403531
1726097bendamustine hydrochloride 25 MG/ML Injectable SolutionSCDf359e7c6-d104-457d-a7fe-597c744403531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83831-183-04838310183041 VIAL in 1 CARTON (83831-183-04) / 4 mL in 1 VIAL1 vial2026-05-29NoNoCurrent