Montelukast Sodium
Product Images NDC 68151-3498

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Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 68151-3498). 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 (68151 3498)

Label Image (68151 3498)
Montelukast Sodium 10 mg tablets label showing the manufacturer as Patheon. It includes lot number 3131858, expiration date 06/16, and a barcode with the number 0000003494. The label also states PDM code 3494 and indicates the product is prescription only.*
FDA Label Image

Figure 1 (Montelukast Sodium 1)

Figure 1 (Montelukast Sodium 1)
A line graph comparing change in height (cm) over weeks of treatment for three groups: SINGULAIR 5 mg, Beclomethasone 336 mcg, and Placebo. The x-axis shows weeks from -16 to 58, and the y-axis shows change in height from approximately -2 to 7 cm. The figure includes a note on the indistinguishable standard errors for the treatment group.*
FDA Label Image

Chemical Structure Of Montelukast Sodium (Montelukast Sodium 2)

Chemical Structure Of Montelukast Sodium (Montelukast Sodium 2)
Chemical structure of Montelukast Sodium showing its molecular framework including chlorine, sulfur, carboxylate (COO-Na+), hydroxyl, and aromatic rings.*
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)

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 mean percent change from baseline over weeks in treatment between Montelukast Sodium and placebo groups. The x-axis shows weeks in treatment from 0 to 15, including a washout period starting after week 12. The y-axis shows mean percent change from baseline, ranging from 0 to 15. Montelukast Sodium shows a higher increase over placebo during treatment, with values peaking around week 12 before declining in the washout period.*

* 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.