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Tranexamic Acid

Tranexamic Acid · TRANEXAMIC ACID 10 mg/mL · Injection, Solution · Intravenous · Sagent Pharmaceuticals

NDC 25021-0418-82 · 10 BAG in 1 CARTON / 100 mL in 1 BAG · ANDA · View full market →

The short version

21 companies supply this market — deep enough that no single failure threatens the supply. 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
$204.79
Reported to Texas DSHS · 2026 annual filing · Sagent Pharmaceuticals

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

Medicaid spend (2025)

$927
41 prescriptions paid by Medicaid nationally · all Medicaid spend →

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 tranexamic acid (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 →

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 · avg $48.39 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA218599
TE code
AP
Approval date
Apr 16, 2024
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Tranexamic Acid (Injection, Solution)

LabelerStrengthFirst seenLast seen
Amneal Pharmaceuticals Private LimitedTRANEXAMIC ACID 10 mg/mLJul 15, 2026Sep 3, 2026
Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.TRANEXAMIC ACID 1 g/10mLJul 15, 2026Sep 3, 2026
Milla Pharmaceuticals Inc.TRANEXAMIC ACID 100 mg/mLSep 3, 2026Sep 3, 2026
Amneal Pharmaceuticals LLCTRANEXAMIC ACID 100 mg/mLJul 15, 2026Sep 2, 2026
Apotex Corp.TRANEXAMIC ACID 100 mg/mLJul 15, 2026Sep 2, 2026
Avenacy Inc.TRANEXAMIC ACID 10 mg/mLJul 15, 2026Sep 2, 2026
Avenacy, Inc.TRANEXAMIC ACID 100 mg/mLJul 15, 2026Sep 2, 2026
Emcure Pharmaceuticals LimitedTRANEXAMIC ACID 1 g/10mLJul 15, 2026Sep 2, 2026
Eugia US LLCTRANEXAMIC ACID 100 mg/mLJul 15, 2026Sep 2, 2026
Exela Pharma Sciences, LLCTRANEXAMIC ACID 10 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCTRANEXAMIC ACID 10 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedTRANEXAMIC ACID 10 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedTRANEXAMIC ACID 100 mg/mLJul 15, 2026Sep 2, 2026
HF Acquisition Co LLC, DBA HealthFirstTRANEXAMIC ACID 100 mg/mLJul 15, 2026Sep 2, 2026
HP Halden Pharma ASTRANEXAMIC ACID 10 mg/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCTRANEXAMIC ACID 100 mg/mLJul 15, 2026Sep 2, 2026
Nexus Pharmaceuticals LLCTRANEXAMIC ACID 10 mg/mLJul 15, 2026Sep 2, 2026
Pfizer Laboratories Div Pfizer IncTRANEXAMIC ACID 100 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsTRANEXAMIC ACID 100 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsTRANEXAMIC ACID 10 mg/mLJul 15, 2026Sep 2, 2026
XGen Pharmaceuticals DJB, Inc.TRANEXAMIC ACID 100 mg/mLJul 15, 2026Sep 2, 2026
Provepharm Inc.TRANEXAMIC ACID 100 mg/mLJul 15, 2026Aug 28, 2026
American Regent, Inc.TRANEXAMIC ACID 100 mg/mLJul 15, 2026Aug 12, 2026

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

Cite this page

DrugDashboards, "Tranexamic Acid — NDC 25021-0418-82," retrieved September 3, 2026, https://drugdashboards.com/drug/25021041882.

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