DrugDashboards

Dimethyl Fumarate

dimethyl-fumarate · DIMETHYL FUMARATE 240 mg/1 · Capsule · Oral · Glenmark Pharmaceuticals Inc., USA

NDC 68462-0308-05 · 500 CAPSULE in 1 BOTTLE · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. One of its named manufacturing plants, Glenmark Pharmaceuticals Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

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
ANDA210309
TE code
AB
Approval date
Oct 6, 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)

LabelerStrengthFirst seenLast seen
Glenmark Pharmaceuticals Inc., USADIMETHYL FUMARATE 120 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USADIMETHYL FUMARATE 240 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 68462-0308-05," retrieved September 3, 2026, https://drugdashboards.com/drug/68462030805.

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