DrugDashboards

Fondaparinux Sodium

Fondaparinux Sodium · FONDAPARINUX SODIUM 7.5 mg/.6mL · Injection, Solution · Subcutaneous · Eugia US LLC

NDC 55150-0232-02 · 2 SYRINGE, GLASS in 1 CARTON / .6 mL in 1 SYRINGE, GLASS · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. One of its named manufacturing plants, Eugia Pharma Specialities Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome. Historically, drugs in this position went on to a new shortage within 90 days about 0.6% of the time — roughly 4× the typical drug (0.1%).

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

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 67457-0584-06) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$74.40per unit
middle half $47.76$110.26 · 4,039 plans · Apr 1, 2026
Est. net of rebates
≈ $74.40
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
73%of plans cover it
tier 5 · prior auth 0% · step therapy 0% · qty limit 20%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

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.

90-day shortage risk (model v2)

0.6%chance of a new FDA shortage posting for fondaparinux sodium (injectable) in the next 90 days

sterile injectable · OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 4× that.

Backtested statistical model over the whole market, not this package alone. Model details →

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 · avg $1,121.26 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA206918
TE code
AP
Approval date
Dec 26, 2017
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedSep 30, 2022
    AuroMedics Pharma LLCSubpotent Drug: Out of specification for assay

Manufacturers of Fondaparinux Sodium (Injection, Solution)

LabelerStrengthFirst seenLast seen
Mylan Institutional LLCFONDAPARINUX SODIUM 7.5 mg/.6mLJul 15, 2026Sep 3, 2026
Mylan Institutional LLCFONDAPARINUX SODIUM 2.5 mg/.5mLJul 15, 2026Sep 3, 2026
Mylan Institutional LLCFONDAPARINUX SODIUM 5 mg/.4mLJul 15, 2026Sep 3, 2026
Mylan Institutional LLCFONDAPARINUX SODIUM 10 mg/.8mLJul 15, 2026Sep 3, 2026
Eugia US LLCFONDAPARINUX SODIUM 7.5 mg/.6mLJul 15, 2026Sep 2, 2026
Eugia US LLCFONDAPARINUX SODIUM 5 mg/.4mLJul 15, 2026Sep 2, 2026
Eugia US LLCFONDAPARINUX SODIUM 2.5 mg/.5mLJul 15, 2026Sep 2, 2026
Eugia US LLCFONDAPARINUX SODIUM 10 mg/.8mLJul 15, 2026Sep 2, 2026
Italfarmaco S.p.AFONDAPARINUX SODIUM 7.5 mg/.6mLJul 15, 2026Sep 2, 2026
Italfarmaco S.p.AFONDAPARINUX SODIUM 2.5 mg/.5mLJul 15, 2026Sep 2, 2026
Italfarmaco S.p.AFONDAPARINUX SODIUM 5 mg/.4mLJul 15, 2026Sep 2, 2026
Italfarmaco S.p.AFONDAPARINUX SODIUM 10 mg/.8mLJul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals (USA) Inc.FONDAPARINUX SODIUM 7.5 mg/.6mLJul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals (USA) Inc.FONDAPARINUX SODIUM 2.5 mg/.5mLJul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals (USA) Inc.FONDAPARINUX SODIUM 10 mg/.8mLJul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals (USA) Inc.FONDAPARINUX SODIUM 5 mg/.4mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Fondaparinux Sodium — NDC 55150-0232-02," retrieved September 3, 2026, https://drugdashboards.com/drug/55150023202.

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