montelukast sodium
montelukast sodium · MONTELUKAST SODIUM 5 mg/1 · Tablet, Chewable · Organon Pharma (Uk) Limited
NDC 60312-0275-00 · 1 BAG in 1 DRUM / 100000 TABLET, CHEWABLE in 1 BAG · DRUG FOR FURTHER PROCESSING · View full market →
Bulk ingredient — not a finished product
This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 78206-0173-01) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
ⓘ How this was built
- CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
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.
*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)
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
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- TE code
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- Approval date
- —
- Patents / exclusivity
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Shortage history
- Planned discontinuation — Singulair, Tablet, Chewable, 4 mg (NDC 78206-170-01)Nov 17, 2025
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of montelukast sodium (Tablet, Chewable)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Proficient Rx LP | MONTELUKAST SODIUM 4 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Ajanta Pharma USA Inc. | MONTELUKAST SODIUM 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvKARE | MONTELUKAST SODIUM 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvKARE | MONTELUKAST SODIUM 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvPAK | MONTELUKAST SODIUM 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| AvPAK | MONTELUKAST SODIUM 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | MONTELUKAST SODIUM 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | MONTELUKAST 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Camber Pharmaceuticals, Inc. | MONTELUKAST 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Chartwell RX, LLC | MONTELUKAST SODIUM 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Chartwell RX, LLC | MONTELUKAST SODIUM 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Direct Rx | MONTELUKAST 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr.Reddy's Laboratories Limited | MONTELUKAST SODIUM 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr.Reddy's Laboratories Limited | MONTELUKAST SODIUM 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lannett Company, Inc. | MONTELUKAST SODIUM 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lannett Company, Inc. | MONTELUKAST SODIUM 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | MONTELUKAST 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | MONTELUKAST 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon LLC | MONTELUKAST SODIUM 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon LLC | MONTELUKAST SODIUM 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon Pharma (Uk) Limited | MONTELUKAST SODIUM 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon Pharma (Uk) Limited | MONTELUKAST SODIUM 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| PD-Rx Pharmaceuticals, Inc. | MONTELUKAST SODIUM 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Preferred Pharmaceuticals, Inc. | MONTELUKAST 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Proficient Rx LP | MONTELUKAST SODIUM 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Rising Pharma Holdings, Inc. | MONTELUKAST SODIUM 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Rising Pharma Holdings, Inc. | MONTELUKAST SODIUM 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Torrent Pharmaceuticals Limited | MONTELUKAST SODIUM 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Torrent Pharmaceuticals Limited | MONTELUKAST SODIUM 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Unichem Pharmaceuticals (USA), Inc. | MONTELUKAST SODIUM 5 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Unichem Pharmaceuticals (USA), Inc. | MONTELUKAST SODIUM 4 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| A-S Medication Solutions | MONTELUKAST 4 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Aurobindo Pharma Limited | MONTELUKAST SODIUM 5 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| A-S Medication Solutions | MONTELUKAST 5 mg/1 | Jul 15, 2026 | Aug 28, 2026 |
| Aurobindo Pharma Limited | MONTELUKAST SODIUM 4 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 60312-0275-00," retrieved September 3, 2026, https://drugdashboards.com/drug/60312027500.
Free to cite with attribution — see how the data is put together.