DrugDashboards

tranexamic acid

tranexamic acid · TRANEXAMIC ACID 100 mg/mL · Injection, Solution · Intravenous · Avenacy, Inc.

NDC 83634-0401-10 · 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

21 companies supply this market — deep enough that no single failure threatens the supply. The price is up 11% over the past year, to $0.3868 per mL. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want. 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.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

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

  • Pharmacies pay (NADAC)$0.3868per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$1.68per dosage unitgross, before rebates — matched by drug name · 2024

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

$0$0.2$0.4Aug 2024Sep 2026$0.3868
17 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$58.00
Reported to Texas DSHS · 2026 annual filing · Avenacy, Inc

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

Supply fragility

10Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • sterile injectable+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

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
ANDA203521
TE code
AP
Approval date
Aug 12, 2014
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 83634-0401-10," retrieved September 3, 2026, https://drugdashboards.com/drug/83634040110.

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