DrugDashboards

Pentasa

mesalamine · MESALAMINE 500 mg/1 · Capsule · Oral · Takeda Pharmaceuticals America, Inc.

NDC 54092-0191-12 · 120 CAPSULE in 1 BOTTLE · NDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. The price has held steady around $5.83 per unit over the past year. 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)$5.83per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$5.03per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$6.20per unitnegotiated price across 936 plans — before rebates · Apr 1, 2026

Medicare Part D

All Part D pricing →
ⓘ 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
$6.20per unit
middle half $6.15$6.26 · 936 plans · Apr 1, 2026
Est. net of rebates
$3.72–$4.65
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
17%of plans cover it
tier 4 · prior auth 0% · step therapy 0% · qty limit 87%

*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 10 quarters since 2024.

NADAC price per unit

$0$2.00$4.00$6.00Oct 2013Sep 2026$5.83
48 price points · per EASource: CMS NADAC

Estimated fill cost

#30 count
$174.77
#90 count
$524.32

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

Medicaid spend (2025)

$14.0M
12,864 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

20Low risk

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

  • 2 active manufacturers+20

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 mesalamine (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 →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 4 across plans
  • Costs ≥ $950/fill · avg $1,357.69 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA020049
TE code
AB
Approval date
May 10, 1993
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class III · TerminatedDec 2, 2016
    Shire PLCPresence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules

Manufacturers of mesalamine (Capsule)

LabelerStrengthFirst seenLast seen
Patheon Manufacturing Services LLCMESALAMINE 250 mg/1Jul 15, 2026Sep 2, 2026
Patheon Manufacturing Services LLCMESALAMINE 500 mg/1Jul 15, 2026Sep 2, 2026
Takeda Pharmaceuticals America, Inc.MESALAMINE 250 mg/1Jul 15, 2026Sep 2, 2026
Takeda Pharmaceuticals America, Inc.MESALAMINE 500 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Pentasa — NDC 54092-0191-12," retrieved September 3, 2026, https://drugdashboards.com/drug/54092019112.

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