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Montelukast sodium

Montelukast sodium · MONTELUKAST SODIUM 1 kg/kg · Granule · Pel Healthcare Llc

NDC 80426-0041-01 · 75 kg in 1 DRUM · 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

This is a bulk ingredient, not a dispensable product — it is a raw material sold to manufacturers and compounders, so no plan prices it.

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 sodium (other) 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 →

Regulatory

Application
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TE code
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Approval date
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Patents / exclusivity
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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 (Granule)

LabelerStrengthFirst seenLast seen
Ajanta Pharma USA Inc.MONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedMONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
Organon LLCMONTELUKAST SODIUM 4 mg/1Jul 15, 2026Sep 2, 2026
Patheon Manufacturing Services LLCMONTELUKAST SODIUM 4 mg/.0005kgJul 15, 2026Sep 2, 2026
Pel Healthcare LlcMONTELUKAST SODIUM 1 kg/kgJul 15, 2026Sep 2, 2026
Torrent Pharmaceuticals LimitedMONTELUKAST SODIUM 4 mg/500mgJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Montelukast sodium — NDC 80426-0041-01," retrieved September 3, 2026, https://drugdashboards.com/drug/80426004101.

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