DrugDashboards

Montelukast Sodium

Montelukast Sodium · MONTELUKAST SODIUM 5 mg/1 · Tablet, Chewable · Oral · Dr.Reddy's Laboratories Limited

NDC 55111-0594-90 · 90 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 price is down 19% over the past year, to $0.1893 per unit.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Part D plans paid (avg)$0.1678per dosage unitgross, before rebates — matched by drug name · 2024
  • Medicaid generic ceiling (FUL)$0.3445per TABweighted avg manufacturer price $0.1969 · Jan 1, 2017

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
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
$9.64per unit
middle half $9.64$9.64 · 2 plans · Apr 1, 2026
Est. net of rebates
≈ $9.64
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 1 · prior auth 0% · step therapy 0% · qty limit 0%

*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

$0$0.2$0.4Nov 2013Nov 2016$0.1893
37 price points · per · last surveyed Nov 1, 2016 · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Medicaid spend (2023)

$422
14 prescriptions paid by Medicaid nationally · all Medicaid spend →

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
ANDA201581
TE code
AB
Approval date
Aug 6, 2012
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation Singulair, Tablet, Chewable, 4 mg (NDC 78206-170-01)Nov 17, 2025

Recalls (this NDC)

  • Class II · TerminatedOct 13, 2023
    Dr. Reddy's Laboratories, Inc.Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.

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 55111-0594-90," retrieved September 3, 2026, https://drugdashboards.com/drug/55111059490.

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