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Riluzole

Riluzole · RILUZOLE 50 mg/1 · Tablet, Film Coated · Oral · Sun Pharmaceutical Industries, Inc.

NDC 62756-0538-88 · 100 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. One of its named manufacturing plants, Sun Pharmaceutical Industries 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)

0.2%chance of a new FDA shortage posting for riluzole (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 →

Regulatory

Application
ANDA091417
TE code
Approval date
Jun 18, 2013
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 Riluzole (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
AvKARERILUZOLE 50 mg/1Jul 15, 2026Sep 2, 2026
Florida Pharmaceutical Products, LLCRILUZOLE 50 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USARILUZOLE 50 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.RILUZOLE 50 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Riluzole — NDC 62756-0538-88," retrieved September 3, 2026, https://drugdashboards.com/drug/62756053888.

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