DrugDashboards

Doxorubicin Hydrochloride

doxorubicin hydrochloride · DOXORUBICIN HYDROCHLORIDE 2 mg/mL · Injectable, Liposomal · Intravenous · Zydus Lifesciences Limited

NDC 49315-0008-03 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

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

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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 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
ANDA212299
TE code
AB
Approval date
Sep 10, 2020
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 doxorubicin hydrochloride (Injectable, Liposomal)

LabelerStrengthFirst seenLast seen
BluePoint LaboratoriesDOXORUBICIN HYDROCHLORIDE 2 mg/mLJul 15, 2026Sep 3, 2026
NorthStar RxLLCDOXORUBICIN HYDROCHLORIDE 2 mg/mLJul 15, 2026Sep 3, 2026
Sun Pharmaceutical Industries, Inc.DOXORUBICIN HYDROCHLORIDE 2 mg/mLJul 15, 2026Sep 3, 2026
Zydus Pharmaceuticals USA Inc.DOXORUBICIN HYDROCHLORIDE 2 mg/mLJul 15, 2026Sep 3, 2026
Zydus Lifesciences LimitedDOXORUBICIN HYDROCHLORIDE 2 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Doxorubicin Hydrochloride — NDC 49315-0008-03," retrieved September 3, 2026, https://drugdashboards.com/drug/49315000803.

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