DrugDashboards

Pedmark

Sodium Thiosulfate · SODIUM THIOSULFATE 12.5 g/100mL · Injection, Solution · Intravenous · Fennec Pharmaceuticals Inc.

NDC 73077-0010-01 · 1 VIAL, SINGLE-DOSE in 1 BOX, UNIT-DOSE / 100 mL in 1 VIAL, SINGLE-DOSE · NDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. One of its named manufacturing plants, Sharp Sterile Manufacturing, LLC, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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
$11,987.94
Reported to Texas DSHS · 2026 annual filing · Fennec Pharmaceuticals Inc.

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

Medicaid spend (2025)

$173,896
17 prescriptions paid by Medicaid nationally · all Medicaid spend →

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
NDA212937
TE code
Approval date
Sep 20, 2022
Patents / exclusivity
7 patents, 1 exclusivities
TypeNumber / codeExpires
exclusivityODE-384Sep 20, 2029
patent11992530Jul 1, 2039
patent11964018Jul 1, 2039
patent11998604Jul 1, 2039
patent11510984Jul 1, 2039
patent11291728Jul 1, 2039
patent11617793Jul 1, 2039
patent10596190Jan 5, 2038

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Sodium Thiosulfate (Injection, Solution)

LabelerStrengthFirst seenLast seen
Fennec Pharmaceuticals Inc.SODIUM THIOSULFATE 12.5 g/100mLJul 15, 2026Sep 2, 2026
Hope PharmaceuticalsSODIUM THIOSULFATE 250 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Pedmark — NDC 73077-0010-01," retrieved September 3, 2026, https://drugdashboards.com/drug/73077001001.

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