Montelukast Sodium
Product Images NDC 68151-4338

4 FDA label images from Carilion Materials Management · 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 68151-4338). 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

Figure 1: Change In Height (cm) From Randomization Visit By Scheduled Week (treatment Group Mean ± Standard Error Of The Mean) (Image 01)

Figure 1: Change In Height (cm) From Randomization Visit By Scheduled Week (treatment Group Mean ± Standard Error Of The Mean) (Image 01)
A line graph depicting change in height (cm) over weeks on treatment for three groups: Montelukast 5 mg, Beclometasone 336 mcg, and Placebo. The x-axis shows weeks from -19 to 56, and the y-axis shows height change from -3 to 7 cm. The graph includes a note that standard errors for treatment groups are too small to be visible.*
FDA Label Image

Montelukast Sodium Structural Formula (Image 02)

Montelukast Sodium Structural Formula (Image 02)
Chemical structure diagram of Montelukast Sodium, showing its molecular components including rings and functional groups.*
FDA Label Image

Figure 2: Fev1 Mean Percent Change From Baseline (u.s. Trial: Montelukast Sodium N = 406; Placebo N = 270) (anova Model) (Image 03)

Figure 2: Fev1 Mean Percent Change From Baseline (u.s. Trial: Montelukast Sodium N = 406; Placebo N = 270) (anova Model) (Image 03)
A line chart showing mean percent change from baseline over weeks in treatment. It compares Montelukast Sodium and placebo groups across 0 to 15 weeks, including a washout period from weeks 12 to 15. Montelukast Sodium shows a higher mean percent change than placebo throughout the treatment period.*
FDA Label Image

Label Image (Lbl681514338)

Label Image (Lbl681514338)
Label of Montelukast Sodium 4 mg chewable tablets manufactured by Teva. The label includes lot number 64M011, expiration date 07/14, product NDC 68151-4338, and indicates the product is prescription only with barcode information.*

* 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.