The short version
6 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.
Lurasidone Hydrochloride
Lurasidone Hydrochloride · LURASIDONE HYDROCHLORIDE 80 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC 47335-0685-13 · 500 TABLET in 1 BOTTLE · ANDA · View full market →
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
- analysis · manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA208066
- TE code
- AB
- Approval date
- Jan 4, 2019
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class II · CompletedJan 18, 2024SUN PHARMACEUTICAL INDUSTRIES INC — CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Class II · CompletedJan 18, 2024SUN PHARMACEUTICAL INDUSTRIES INC — CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Manufacturers of Lurasidone Hydrochloride (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Aurobindo Pharma Limited | LURASIDONE HYDROCHLORIDE 60 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Aurobindo Pharma Limited | LURASIDONE HYDROCHLORIDE 40 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Coupler LLC | LURASIDONE HYDROCHLORIDE 60 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | LURASIDONE HYDROCHLORIDE 80 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | LURASIDONE HYDROCHLORIDE 120 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | LURASIDONE HYDROCHLORIDE 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | LURASIDONE HYDROCHLORIDE 60 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | LURASIDONE HYDROCHLORIDE 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Proficient Rx LP | LURASIDONE HYDROCHLORIDE 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Remedyrepack Inc. | LURASIDONE HYDROCHLORIDE 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | LURASIDONE HYDROCHLORIDE 80 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | LURASIDONE HYDROCHLORIDE 120 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | LURASIDONE HYDROCHLORIDE 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | LURASIDONE HYDROCHLORIDE 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | LURASIDONE HYDROCHLORIDE 60 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | LURASIDONE HYDROCHLORIDE 80 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Aurobindo Pharma Limited | LURASIDONE HYDROCHLORIDE 120 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Aurobindo Pharma Limited | LURASIDONE HYDROCHLORIDE 20 mg/1 | Jul 15, 2026 | Aug 28, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Lurasidone Hydrochloride — NDC 47335-0685-13," retrieved September 3, 2026, https://drugdashboards.com/drug/47335068513.
Free to cite with attribution — see how the data is put together.