DrugDashboards

Lurasidone Hydrochloride

Lurasidone Hydrochloride · LURASIDONE HYDROCHLORIDE 40 mg/1 · Tablet, Coated · Oral · Amneal Pharmaceuticals LLC

NDC 65162-0880-50 · 500 TABLET, COATED in 1 BOTTLE · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble.

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 lurasidone hydrochloride (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
ANDA208002
TE code
—
Approval date
Jan 3, 2019
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 Lurasidone Hydrochloride (Tablet, Coated)

LabelerStrengthFirst seenLast seen
Amneal Pharmaceuticals LLCLURASIDONE HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCLURASIDONE HYDROCHLORIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCLURASIDONE HYDROCHLORIDE 80 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCLURASIDONE HYDROCHLORIDE 40 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCLURASIDONE HYDROCHLORIDE 120 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCLURASIDONE HYDROCHLORIDE 40 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCLURASIDONE HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCLURASIDONE HYDROCHLORIDE 80 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCLURASIDONE HYDROCHLORIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCLURASIDONE HYDROCHLORIDE 120 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedLURASIDONE HYDROCHLORIDE 40 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedLURASIDONE HYDROCHLORIDE 120 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedLURASIDONE HYDROCHLORIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedLURASIDONE HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedLURASIDONE HYDROCHLORIDE 80 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.LURASIDONE HYDROCHLORIDE 60 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.LURASIDONE HYDROCHLORIDE 20 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.LURASIDONE HYDROCHLORIDE 120 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.LURASIDONE HYDROCHLORIDE 40 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.LURASIDONE HYDROCHLORIDE 80 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Lurasidone Hydrochloride — NDC 65162-0880-50," retrieved September 3, 2026, https://drugdashboards.com/drug/65162088050.

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