The short version
5 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.
Montelukast Sodium
Montelukast Sodium · MONTELUKAST SODIUM 10 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC 68788-8610-03 · 30 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 montelukast sodium (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 →
Regulatory
- Application
- ANDA201515
- TE code
- AB
- Approval date
- Aug 3, 2012
- 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 Montelukast Sodium (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Preferred Pharmaceuticals Inc. | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Proficient Rx LP | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Rising Pharma Holdings, Inc. | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Torrent Pharmaceuticals Limited | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Westminster Pharmaceuticals, LLC | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Montelukast Sodium — NDC 68788-8610-03," retrieved September 3, 2026, https://drugdashboards.com/drug/68788861003.
Free to cite with attribution — see how the data is put together.