DrugDashboards

Dimethyl Fumarate

Dimethyl Fumarate · DIMETHYL FUMARATE 240 mg/1 · Capsule, Delayed Release · Oral · Camber Pharmaceuticals, Inc.

NDC 31722-0658-31 · 1 BOTTLE in 1 CARTON / 46 CAPSULE, DELAYED 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 24979-0128-04) — 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ⓘ
$2.00per unit
middle half $1.47–$7.26 · 4,096 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $2.00
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
75%of plans cover it
tier 4 · prior auth 69% · step therapy 0% · qty limit 95%

*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 4 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 dimethyl fumarate (oral solid) in the next 90 days

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 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
  • Costs ≥ $950/fill · avg $1,141.99 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA210500
TE code
AB
Approval date
Sep 24, 2020
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 Dimethyl Fumarate (Capsule, Delayed Release)

LabelerStrengthFirst seenLast seen
Golden State Medical Supply, Inc.DIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 3, 2026
Golden State Medical Supply, Inc.DIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 3, 2026
A-S Medication SolutionsDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare Inc.DIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare Inc.DIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.DIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.DIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Cipla USA Inc.DIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Cipla USA Inc.DIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
CivicaScript LLCDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
CivicaScript LLCDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories Inc.DIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories Inc.DIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Msn Laboratories Private LimitedDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Msn Laboratories Private LimitedDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Quallent Pharmaceuticals Health LLCDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
SOLA Pharmaceuticals, LLCDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
SOLA Pharmaceuticals, LLCDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Solco Healthcare US, LLCDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Solco Healthcare US, LLCDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Upsher-Smith Laboratories, LLCDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Upsher-Smith Laboratories, LLCDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedDIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedDIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.DIMETHYL FUMARATE 240 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.DIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Dimethyl Fumarate — NDC 31722-0658-31," retrieved September 3, 2026, https://drugdashboards.com/drug/31722065831.

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