DrugDashboards

Montelukast Sodium

Montelukast Sodium · MONTELUKAST 5 mg/1 · Tablet, Chewable · Oral · Direct Rx

NDC 72189-0223-30 · 30 TABLET, CHEWABLE in 1 BOTTLE · ANDA · View full market →

The short version

20 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.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 31722-0728-90) — 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
$0.1998per unit
middle half $0.1126$0.3083 · 5,495 plans · Apr 1, 2026
Est. net of rebates
≈ $0.1998
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 →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
ANDA204093
TE code
AB
Approval date
May 22, 2015
Patents / exclusivity
None on file

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)

LabelerStrengthFirst seenLast seen
Proficient Rx LPMONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 3, 2026
Ajanta Pharma USA Inc.MONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
AvKAREMONTELUKAST SODIUM 5 mg/1Jul 15, 2026Sep 2, 2026
AvKAREMONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
AvPAKMONTELUKAST SODIUM 5 mg/1Jul 15, 2026Sep 2, 2026
AvPAKMONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackMONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.MONTELUKAST 4 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.MONTELUKAST 5 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCMONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCMONTELUKAST SODIUM 5 mg/1Jul 15, 2026Sep 2, 2026
Direct RxMONTELUKAST 5 mg/1Jul 15, 2026Sep 2, 2026
Dr.Reddy's Laboratories LimitedMONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
Dr.Reddy's Laboratories LimitedMONTELUKAST SODIUM 5 mg/1Jul 15, 2026Sep 2, 2026
Lannett Company, Inc.MONTELUKAST SODIUM 5 mg/1Jul 15, 2026Sep 2, 2026
Lannett Company, Inc.MONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedMONTELUKAST 5 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedMONTELUKAST 4 mg/1Jul 15, 2026Sep 2, 2026
Organon LLCMONTELUKAST SODIUM 5 mg/1Jul 15, 2026Sep 2, 2026
Organon LLCMONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
Organon Pharma (Uk) LimitedMONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
Organon Pharma (Uk) LimitedMONTELUKAST SODIUM 5 mg/1Jul 15, 2026Sep 2, 2026
PD-Rx Pharmaceuticals, Inc.MONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals, Inc.MONTELUKAST 5 mg/1Jul 15, 2026Sep 2, 2026
Proficient Rx LPMONTELUKAST SODIUM 5 mg/1Jul 15, 2026Sep 2, 2026
Rising Pharma Holdings, Inc.MONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
Rising Pharma Holdings, Inc.MONTELUKAST SODIUM 5 mg/1Jul 15, 2026Sep 2, 2026
Torrent Pharmaceuticals LimitedMONTELUKAST SODIUM 5 mg/1Jul 15, 2026Sep 2, 2026
Torrent Pharmaceuticals LimitedMONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
Unichem Pharmaceuticals (USA), Inc.MONTELUKAST SODIUM 5 mg/1Jul 15, 2026Sep 2, 2026
Unichem Pharmaceuticals (USA), Inc.MONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
A-S Medication SolutionsMONTELUKAST 4 mg/1Jul 15, 2026Aug 31, 2026
Aurobindo Pharma LimitedMONTELUKAST SODIUM 5 mg/1Jul 15, 2026Aug 31, 2026
A-S Medication SolutionsMONTELUKAST 5 mg/1Jul 15, 2026Aug 28, 2026
Aurobindo Pharma LimitedMONTELUKAST SODIUM 4 mg/1Jul 15, 2026Aug 28, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Montelukast Sodium — NDC 72189-0223-30," retrieved September 3, 2026, https://drugdashboards.com/drug/72189022330.

Free to cite with attribution — see how the data is put together.