DrugDashboards

Melphalan Hydrochloride

melphalan hydrochloride · Kit · Intravenous · Qilu Pharmaceutical Co., Ltd.

NDC 67184-0618-02 · 1 KIT in 1 CARTON * 15 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL, SINGLE-USE · ANDA · View full market →

The short version

13 companies supply this market — deep enough that no single failure threatens the supply.

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.

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Is this a "specialty" drug?

There's no legal definition — it meets 2 of 6 public criteria. Why that matters →

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

Regulatory

Application
ANDA211463
TE code
AP
Approval date
Sep 13, 2019
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 melphalan hydrochloride (Kit)

LabelerStrengthFirst seenLast seen
Dr.Reddy's Laboratories IncJul 15, 2026Sep 3, 2026
Arthur Group LLCJul 15, 2026Sep 2, 2026
Avenacy Inc.Jul 15, 2026Sep 2, 2026
BPI Labs LLCJul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.Jul 15, 2026Sep 2, 2026
Fosun Pharma USA IncJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCJul 15, 2026Sep 2, 2026
Gland Pharma LimitedJul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.Jul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.Jul 15, 2026Sep 2, 2026
Mylan Institutional LLCJul 15, 2026Sep 2, 2026
Qilu Pharmaceutical Co., Ltd.Jul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Melphalan Hydrochloride — NDC 67184-0618-02," retrieved September 3, 2026, https://drugdashboards.com/drug/67184061802.

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