Montelukast Sodium
Product Images NDC 68151-3494

Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 68151-3494). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Carilion Materials Management, 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

Label Image (Lbl681513494)

Montelukast Sodium 10 mg tablets label showing manufacturer Patheon, lot number 3131858, expiration date 06/16, product code W120615N1, and barcode with number 0000003494 as part of packaging details. Product is prescription only.*

FDA Label Image

Figure 1 (Montelukast Sodium 1)

A line graph illustrating change in height (cm) over weeks of treatment for three groups: SINGULAIR 5 mg, Beclomethasone 336 mcg, and Placebo. The graph shows trends of height increase across approximately 60 weeks, with error bars indicating standard errors noted as too small to be visible on the plot.*

FDA Label Image

Chemical Structure Of Montelukast Sodium (Montelukast Sodium 2)

Chemical structure of Montelukast Sodium, showing its molecular framework including a chlorinated quinoline ring, a thiophene linkage, a cyclopropane carboxylate sodium salt group, and a hydroxyl-substituted aromatic ring with isopropyl substituents.*

FDA Label Image

Figure 2: Fev1 Mean Percent Change From Baseline (u.s. Trial: Montelukast Sodium N=406; Placebo N=270)(anova Model) (Montelukast Sodium 3)

A line graph comparing the mean percent change from baseline over weeks in treatment between Montelukast Sodium and placebo groups. The x-axis shows weeks in treatment (0 to 15), while the y-axis displays mean percent change from baseline (0 to 15). Montelukast Sodium shows a higher increase than placebo, with data points and error bars for each time point, including a washout phase after week 12.*

* 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.