DrugDashboards

Tranexamic Acid

Tranexamic Acid · TRANEXAMIC ACID 100 mg/mL · Injection · Intravenous · Micro Labs Limited

NDC 42571-0314-89 · 10 CARTON in 1 CARTON / 1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS · ANDA · View full market →

The short version

7 companies supply this market — a reasonable cushion if one runs into trouble. 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.

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
ANDA206713
TE code
AP
Approval date
Jun 27, 2017
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)

LabelerStrengthFirst seenLast seen
Baxter Healthcare CorporationTRANEXAMIC ACID 100 mg/mLJul 15, 2026Sep 2, 2026
Caplin Steriles LimitedTRANEXAMIC ACID 100 mg/mLJul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.TRANEXAMIC ACID 100 mg/mLJul 15, 2026Sep 2, 2026
Northstar Rx LLCTRANEXAMIC ACID 100 mg/mLJul 15, 2026Sep 2, 2026
Remedyrepack Inc.TRANEXAMIC ACID 100 mg/mLJul 15, 2026Sep 2, 2026
Armas Pharmaceuticals Inc.TRANEXAMIC ACID 100 mg/mLJul 15, 2026Aug 31, 2026
Micro Labs LimitedTRANEXAMIC ACID 100 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Tranexamic Acid — NDC 42571-0314-89," retrieved September 3, 2026, https://drugdashboards.com/drug/42571031489.

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