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.
Montelukast Sodium
Montelukast · MONTELUKAST SODIUM 10 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC 65162-0732-03 · 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 (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 →
Regulatory
- Application
- ANDA204604
- TE code
- AB
- Approval date
- Sep 4, 2015
- 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 (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Coupler LLC | MONTELUKAST SODIUM 10 mg/1 | Aug 6, 2026 | Sep 3, 2026 |
| Amneal Pharmaceuticals LLC | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| BluePoint Laboratories | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| NuCare Pharmaceuticals, Inc. | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| NuCare Pharmaceuticals,Inc. | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Redpharm Drug | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Montelukast Sodium — NDC 65162-0732-03," retrieved September 3, 2026, https://drugdashboards.com/drug/65162073203.
Free to cite with attribution — see how the data is put together.