DrugDashboards

Dabigatran Etexilate

Dabigatran Etexilate · DABIGATRAN ETEXILATE MESYLATE 150 mg/1 · Capsule, Coated Pellets · Oral · Major Pharmaceuticals

NDC 00904-7255-10 · 2 BLISTER PACK in 1 CARTON / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. The price has fallen 35% in a year, to $0.8226 per unit — and generics that get this cheap tend to get abandoned rather than defended. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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)$0.8226per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$2.25per dosage unitgross, before rebates — matched by drug name · 2024

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 67877-0475-60) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

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

Plans pay at point of sale
$4.53per unit
middle half $3.73$6.01 · 4,455 plans · Jan 1, 2024
Est. net of rebates
≈ $4.53
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
of plans cover it

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 1 quarter since 2024.

NADAC price per unit

$0$0.5$1.00$1.50Sep 2025Sep 2026$0.8226
13 price points · per EASource: CMS NADAC

Estimated fill cost

#30 count
$24.68
#90 count
$74.03

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Supply fragility

18Low risk

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

  • 3 active manufacturers+10
  • price down 35% year over year+8

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)

0.1%chance of a new FDA shortage posting for dabigatran etexilate (oral solid) in the next 90 days

sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

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 →

Regulatory

Application
ANDA208040
TE code
AB
Approval date
Mar 11, 2020
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class III · OngoingJul 16, 2026
    Ascend Laboratories, LLCFailed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
  • Class III · OngoingJul 16, 2026
    Ascend Laboratories, LLCFailed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
  • Class III · OngoingJul 16, 2026
    Ascend Laboratories, LLCFailed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
  • Class III · OngoingJun 30, 2026
    Ascend Laboratories, LLCFailed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
  • Class III · OngoingJun 30, 2026
    Ascend Laboratories, LLCFailed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.

Manufacturers of Dabigatran Etexilate (Capsule, Coated Pellets)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsDABIGATRAN ETEXILATE MESYLATE 75 mg/1Jul 15, 2026Sep 2, 2026
A-S Medication SolutionsDABIGATRAN ETEXILATE MESYLATE 150 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCDABIGATRAN ETEXILATE MESYLATE 75 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCDABIGATRAN ETEXILATE MESYLATE 110 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCDABIGATRAN ETEXILATE MESYLATE 150 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsDABIGATRAN ETEXILATE MESYLATE 75 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsDABIGATRAN ETEXILATE MESYLATE 110 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsDABIGATRAN ETEXILATE MESYLATE 150 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Dabigatran Etexilate — NDC 00904-7255-10," retrieved September 3, 2026, https://drugdashboards.com/drug/00904725510.

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