Montelukast

Drug ingredient

CAS 158966-92-8

This chemical is an active pharmaceutical ingredient used in FDA-regulated drugs.

US productionNot reported

Import value, 2024$111M

Top sourceIndia 28%

This chemical is not on EPA’s Toxic Substances Control Act inventory, the list behind EPA’s production survey.

Why supply is unknown

Production is reported production, not a complete census of factories. Import value and source-country shares describe a shared customs category, not a separate chemical measurement.

Where It Comes From

Customs basis: HS 293349 · basket

These shares come from HS customs code 293349, which covers 94 tracked chemicals in total. They estimate the category's origin mix, not this chemical specifically.

Source Countries

Country of origin for US imports, from Census customs data (2024).

IN 28%IndiaCN 27%ChinaSE 12%SwedenKR 10%South KoreaGB 4%United Kingdom

Spain
Portugal
Germany
Netherlands
Israel
Australia
Taiwan
Lithuania
South Africa
Hong Kong

5 FDA-registered drug labelers

A-S Medication Solutions

Camber Pharmaceuticals, Inc.

DIRECT RX

Macleods Pharmaceuticals Limited

Preferred Pharmaceuticals, Inc.

Why It Matters

Sectors

Health

Downstream Uses

Appears in 1 drug and cosmetic product listings (FDA).

•montelukast sodium

FDA Shortage Status

Whether any manufacturer currently reports this drug as in shortage on the FDA Drug Shortages database. "Active Shortage" means at least one presentation has status "current."

No Shortage

Shortage History

Rows group FDA shortage filings by drug product. Each manufacturer makes its own FDA shortage filing, so one product can carry several reports at once: Available, Limited Availability, Unavailable or to be discontinued.

to be discontinued
Montelukast Sodium Tablet, Chewable
Shortage listed since November 17, 2025

See all current drug shortages

Chemical Identity

CAS158966-92-8

PubChem CID5281040

DTXSIDDTXSID9023334

FormulaC35H36ClNO3S

Mol. Weight586.2 g/mol

SMILESCC(C)(C1=CC=CC=C1CCC(C2=CC=CC(=C2)C=CC3=NC4=C(C=CC(=C4)Cl)C=C3)SCC5(CC5)CC(=O)O)O

Data Sources

PubChem · compound 5281040Retrieved 2026-04-07
FDA National Drug Code directoryRetrieved 2026-04-25
FDA Drug ShortagesRetrieved 2026-10-04
US Census international tradeReporting year: 2024 · Retrieved 2026-10-04

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Brief citations

Montelukast (CAS 158966-92-8) https://chemicalindependence.com/chemical/158966-92-8/ PubChem: 5281040. Retrieved 2026-04-07. https://pubchem.ncbi.nlm.nih.gov/compound/5281040 FDA National Drug Code directory: CAS 158966-92-8. Retrieved 2026-04-25. https://open.fda.gov/data/ndc/ FDA Drug Shortages: CAS 158966-92-8. Retrieved 2026-10-04. https://www.accessdata.fda.gov/scripts/drugshortages/ US Census international trade: HS 293349 for CAS 158966-92-8. Reporting year: 2024. https://usatrade.census.gov/