Data / Drug companies / Montelukast sodium

Montelukast sodium: 31 companies and 73 products in the FDA NDC directory

Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).

Montelukast sodium is listed in the FDA National Drug Code Directory by 31 companies, with 73 products in commercial distribution. 69 of the products (94.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, chewable; tablet, film coated; tablet, and the newest product started marketing on September 14, 2026.

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Companies listing it

31

Products

73

Generic (ANDA) products

69 (94.5%)

Application numbers

23

Routes

Oral

Brand names

Singulair, Montelukast

openFDA record search

api.fda.gov

Companies that list montelukast sodium

Ranked by number of products. Finished drugs in commercial distribution.

Dosage forms

Marketing categories

Pharmacologic classes

CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.