DrugDashboards

Mesalamine

Mesalamine · MESALAMINE 500 mg/1 · Capsule, Extended Release · Oral · Sun Pharmaceutical Industries Inc.

NDC 63304-0089-13 · 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

18 companies supply this market — deep enough that no single failure threatens the supply. The price is down 25% over the past year, to $3.47 per unit. 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)$3.47per EAinvoice-surveyed acquisition cost · Jun 18, 2025
  • Part D plans paid (avg)$103.72per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$4.43per unitnegotiated price across 2,046 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
$4.43per unit
middle half $4.30$4.80 · 2,046 plans · Apr 1, 2026
Est. net of rebates
≈ $4.43
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
37%of plans cover it
tier 4 · prior auth 1% · step therapy 0% · qty limit 57%

*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$6.00Aug 2022Jun 2025$3.47
25 price points · per EA · last surveyed Invalid DateSource: CMS NADAC

Estimated fill cost

#30 count
$104.11
#90 count
$312.34

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

Medicaid spend (2025)

$194,484
290 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

0Low risk

Nothing here is signaling trouble: several manufacturers, no current shortage, no recent serious recalls, stable pricing. In drug supply, boring is the good outcome.

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 →

Regulatory

Application
ANDA214585
TE code
AB
Approval date
May 11, 2022
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation Mesalamine, Capsule, Extended Release, .375 g (NDC 0378-1375-78)Aug 25, 2026

Recalls (this NDC)

  • Class II · OngoingFeb 5, 2024
    SUN PHARMACEUTICAL INDUSTRIES INCFailed Dissolution Specifications: Out of specification for dissolution.

Manufacturers of Mesalamine (Capsule, Extended Release)

LabelerStrengthFirst seenLast seen
Alembic Pharmaceuticals Inc.MESALAMINE .375 g/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedMESALAMINE .375 g/1Jul 15, 2026Sep 2, 2026
American Health PackagingMESALAMINE .375 g/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCMESALAMINE .375 g/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedMESALAMINE .375 g/1Jul 15, 2026Sep 2, 2026
AvPAKMESALAMINE .375 g/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.MESALAMINE 375 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.MESALAMINE .375 g/1Jul 15, 2026Sep 2, 2026
Ingenus Pharmaceuticals, LLCMESALAMINE .375 g/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.MESALAMINE .375 g/1Jul 15, 2026Sep 2, 2026
Oceanside PharmaceuticalsMESALAMINE 375 mg/1Jul 15, 2026Sep 2, 2026
Salix Pharmaceuticals, Inc.MESALAMINE 375 mg/1Jul 15, 2026Sep 2, 2026
Sandoz IncMESALAMINE 500 mg/1Jul 15, 2026Sep 2, 2026
Sandoz IncMESALAMINE 250 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries Inc.MESALAMINE 500 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.MESALAMINE 375 mg/1Jul 15, 2026Sep 2, 2026
Upsher-Smith Laboratories, LLCMESALAMINE .375 g/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedMESALAMINE .375 g/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.MESALAMINE .375 g/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Mesalamine — NDC 63304-0089-13," retrieved September 3, 2026, https://drugdashboards.com/drug/63304008913.

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