FDA.reportPublic FDA data

GOBARDEN

Product NDC
83831-176
11-digit product format
838310176
Labeler code
83831
Product ID
83831-176_d2d3080a-6cef-4a91-8035-6fd8b41109e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bendamustine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
AVYXA Pharma, LLC
Application
NDA219014
Marketing category
NDA
Marketing start
2026-09-25
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
GOBARDEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENDAMUSTINE HYDROCHLORIDE100 mg/4mL

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83831-176-04838310176041 VIAL in 1 CARTON (83831-176-04) / 4 mL in 1 VIAL1 vial2026-09-25NoNoCurrent