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Doxorubicin Hydrochloride

Doxorubicin Hydrochloride · DOXORUBICIN HYDROCHLORIDE 2 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC

NDC 63323-0883-10 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

7 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.

Estimated fill cost

WAC per package, as filed
$26.00
Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

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
ANDA063277
TE code
AP
Approval date
Oct 26, 1995
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class III · TerminatedNov 17, 2020
    Fresenius Kabi USA, LLCCross Contamination with Other Products: trace amounts of octreotide found during testing

Manufacturers of Doxorubicin Hydrochloride (Injection, Solution)

LabelerStrengthFirst seenLast seen
Gland Pharma LimitedDOXORUBICIN HYDROCHLORIDE 2 mg/mLJul 15, 2026Sep 3, 2026
Hikma Pharmaceuticals USA Inc.DOXORUBICIN HYDROCHLORIDE 2 mg/mLJul 15, 2026Sep 3, 2026
Actavis Pharma, Inc.DOXORUBICIN HYDROCHLORIDE 2 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsDOXORUBICIN HYDROCHLORIDE 2 mg/mLJul 15, 2026Sep 2, 2026
Pfizer Laboratories Div Pfizer IncDOXORUBICIN HYDROCHLORIDE 2 mg/mLJul 15, 2026Aug 31, 2026
Sun Pharmaceutical Industries, Inc.DOXORUBICIN HYDROCHLORIDE 2 mg/mLJul 15, 2026Aug 31, 2026
Fresenius Kabi USA, LLCDOXORUBICIN HYDROCHLORIDE 2 mg/mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Doxorubicin Hydrochloride — NDC 63323-0883-10," retrieved September 3, 2026, https://drugdashboards.com/drug/63323088310.

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