DrugDashboards

Bendamustine Hydrochloride

bendamustine hydrochloride · BENDAMUSTINE HYDROCHLORIDE 100 mg/4mL · Injection · Intravenous · Avyxa Pharma, LLC

NDC 83831-0183-04 · 1 VIAL in 1 CARTON / 4 mL in 1 VIAL · NDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA219014
TE code
Approval date
Jul 3, 2025
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of bendamustine hydrochloride (Injection)

LabelerStrengthFirst seenLast seen
Avyxa Pharma, LLCBENDAMUSTINE HYDROCHLORIDE 100 mg/4mLJul 15, 2026Sep 2, 2026
Azurity Pharmaceuticals, Inc.BENDAMUSTINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationBENDAMUSTINE HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Eagle Pharmaceuticals, IncBENDAMUSTINE HYDROCHLORIDE 100 mg/4mLJul 15, 2026Sep 2, 2026
Slayback Pharma LLCBENDAMUSTINE HYDROCHLORIDE 25 mg/mLJul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Bendamustine Hydrochloride — NDC 83831-0183-04," retrieved September 3, 2026, https://drugdashboards.com/drug/83831018304.

Free to cite with attribution — see how the data is put together.