The short version
17 companies supply this market — deep enough that no single failure threatens the supply.
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, Film Coated · Oral · Cardinal Health 107, LLC
NDC 55154-8075-00 · 10 BLISTER PACK in 1 BAG / 1 TABLET, FILM COATED in 1 BLISTER PACK · ANDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 65862-0574-90) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
ⓘ How this was built
Data sources
- CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method
Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
Plans pay at point of saleⓘ
$0.1511per unit
middle half $0.1146–$0.2534 · 5,496 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $0.1511
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 1 · prior auth 0% · step therapy 0% · qty limit 55%
*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.
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
- 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 Sodium (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Aurobindo Pharma Limited | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Bryant Ranch Prepack | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| NuCare Pharmaceuticals,Inc. | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Proficient Rx LP | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| A-S Medication Solutions | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Accord Healthcare Inc. | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Cardinal Health 107, LLC | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Direct_Rx | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Major Pharmaceuticals | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon LLC | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon Pharma (Uk) Limited | 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 |
| Redpharm Drug | 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 |
| Unichem Pharmaceuticals (USA), Inc. | MONTELUKAST SODIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| PD-Rx Pharmaceuticals, Inc. | MONTELUKAST SODIUM 10 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, "Montelukast Sodium — NDC 55154-8075-00," retrieved September 3, 2026, https://drugdashboards.com/drug/55154807500.
Free to cite with attribution — see how the data is put together.