Montelukast Sodium
Product Images NDC 53217-357

4 FDA label images from Aidarex Pharmaceuticals Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 53217-357). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aidarex Pharmaceuticals Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure_01 (Montelukast Sodium 5mg 1)

Figure_01 (Montelukast Sodium 5mg 1)
A line graph depicting change in height (cm) over weeks on treatment for Montelukast sodium chewable tablets 5 mg, Beclomethasone 336 mcg, and placebo groups. The x-axis represents weeks on treatment from -19 to 56, and the y-axis represents change in height from -3 to 7 cm. The graph shows growth trends with standard errors noted as too small to be visible.*
FDA Label Image

Structure (Montelukast Sodium 5mg 2)

Structure (Montelukast Sodium 5mg 2)
Chemical structure of montelukast sodium, showing its molecular composition and chemical bonds as represented in the image associated with Aidarex Pharmaceuticals LLC product NDC 53217-357.*
FDA Label Image

Figure_2 (Montelukast Sodium 5mg 3)

Figure_2 (Montelukast Sodium 5mg 3)
A line graph comparing mean percent change from baseline over 15 weeks of treatment between Montelukast sodium tablets and placebo. The x-axis represents weeks in treatment, including a washout period, and the y-axis shows mean percent change from baseline. Montelukast shows consistently higher mean percent changes versus placebo throughout the study period.*
FDA Label Image

53217-0357_montelukast-sod_chew-5mg (Montelukast Sodium 5mg 4)

53217-0357_montelukast-sod_chew-5mg (Montelukast Sodium 5mg 4)
Montelukast Sodium 5 mg chewable tablets, packaged in a bottle containing 30 tablets, labeled as a generic product for Singulair 5 mg. The label indicates the product is manufactured by Ajanta Pharma Limited, India, and distributed by Aidarex Pharmaceuticals LLC. The label includes directions to use one tablet by mouth daily and various national drug codes (NDCs).*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.