The short version
9 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
Montelukast · MONTELUKAST SODIUM 10 mg/1 · Tablet, Film Coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC 71610-0563-30 · 30 TABLET, FILM COATED 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 →
Where it's made
- Aphena Pharma Solutions - Tennessee, LLCUnited Statesrepack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA202843
- TE code
- AB
- Approval date
- Sep 10, 2014
- 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, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| A-S Medication Solutions | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aphena Pharma Solutions - Tennessee, LLC | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvPAK | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Preferred Pharmaceuticals, Inc. | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Quallent Pharmaceuticals Health LLC | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Remedyrepack Inc. | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sandoz Inc | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| XLCare Pharmaceuticals Inc. | 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 — NDC 71610-0563-30," retrieved September 3, 2026, https://drugdashboards.com/drug/71610056330.
Free to cite with attribution — see how the data is put together.