DrugDashboards

Vyxeos

(daunorubicin and cytarabine) liposome · CYTARABINE 100 mg/20mL; DAUNORUBICIN 44 mg/20mL · Injection, Powder, Lyophilized, For Suspension · Intravenous · Jazz Pharmaceuticals, Inc.

NDC 68727-0745-01 · 20 mL in 1 VIAL · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. One of its named manufacturing plants, Simtra Deutschland GmbH, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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 2 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
NDA209401
TE code
Approval date
Aug 3, 2017
Patents / exclusivity
15 patents, 2 exclusivities
TypeNumber / codeExpires
exclusivityPEDSep 30, 2028
exclusivityODE-350Mar 30, 2028
patent10028912*PEDApr 15, 2033
patent10835492*PEDApr 15, 2033
patent10166184*PEDApr 15, 2033
patent10835492Oct 15, 2032
patent10166184Oct 15, 2032
patent10028912Oct 15, 2032
patent8092828*PEDOct 1, 2029
patent8092828Apr 1, 2029
patent8022279*PEDMar 14, 2028
patent8022279Sep 14, 2027

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of (daunorubicin and cytarabine) liposome (Injection, Powder, Lyophilized, For Suspension)

LabelerStrengthFirst seenLast seen
Jazz Pharmaceuticals, Inc.CYTARABINE 100 mg/20mL; DAUNORUBICIN 44 mg/20mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Vyxeos — NDC 68727-0745-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68727074501.

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