DrugDashboards

Mesalamine

Mesalamine · MESALAMINE 375 mg/1 · Capsule, Extended Release · Oral · Camber Pharmaceuticals, Inc.

NDC 31722-0489-12 · 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 numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 65649-0103-02) — 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
$4.17per unit
middle half $4.17$4.17 · 2 plans · Apr 1, 2026
Est. net of rebates
≈ $4.17
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 1 · prior auth 0% · step therapy 0% · qty limit 100%

*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

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)

0.1%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
ANDA219864
TE code
AB
Approval date
Aug 13, 2025
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)

No enforcement reports list this package NDC.

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 31722-0489-12," retrieved September 3, 2026, https://drugdashboards.com/drug/31722048912.

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