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Fondaparinux Sodium

Fondaparinux Sodium · FONDAPARINUX SODIUM 5 mg/.4mL · Injection · Subcutaneous · Sandoz Inc.

NDC 00781-3454-12 · 2 SYRINGE in 1 CARTON / .4 mL in 1 SYRINGE · ANDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. 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

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
$190.12
Reported to Texas DSHS · 2022 annual filing · Sandoz Inc.

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

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
ANDA206812
TE code
—
Approval date
May 15, 2018
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation — Fondaparinux Sodium, Injection, 10 mg/.8 mL (NDC 0781-3476-95)Sep 29, 2025
  • Planned discontinuation — Fondaparinux Sodium, Injection, 2.5 mg/.5 mL (NDC 0781-3443-95)Sep 29, 2025
  • Planned discontinuation — Fondaparinux Sodium, Injection, 5 mg/.4 mL (NDC 0781-3454-95)Sep 29, 2025
  • Planned discontinuation — Fondaparinux Sodium, Injection, 7.5 mg/.6 mL (NDC 0781-3465-95)Sep 29, 2025

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Fondaparinux Sodium (Injection)

LabelerStrengthFirst seenLast seen
Dr. Reddy's Laboratories LimitedFONDAPARINUX SODIUM 5 mg/.4mLJul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories LimitedFONDAPARINUX SODIUM 10 mg/.8mLJul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories LimitedFONDAPARINUX SODIUM 7.5 mg/.6mLJul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories LimitedFONDAPARINUX SODIUM 2.5 mg/.5mLJul 15, 2026Sep 2, 2026
Sandoz Inc.FONDAPARINUX SODIUM 7.5 mg/.6mLJul 15, 2026Sep 2, 2026
Sandoz Inc.FONDAPARINUX SODIUM 2.5 mg/.5mLJul 15, 2026Sep 2, 2026
Sandoz Inc.FONDAPARINUX SODIUM 5 mg/.4mLJul 15, 2026Sep 2, 2026
Sandoz Inc.FONDAPARINUX SODIUM 10 mg/.8mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Fondaparinux Sodium — NDC 00781-3454-12," retrieved September 3, 2026, https://drugdashboards.com/drug/00781345412.

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