Montelukast Sodium
Product Images NDC 71610-129

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 71610-129). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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

Bottle Label 10 mg (71610 0129 09)

Montelukast Sodium 10 mg 9000 Tablets label showing the product name, strength, and quantity. The label indicates it is repackaged by Aphena Pharma Solutions - Tennessee, LLC with manufacturing by Aurorendo Pharma Limited, Hyderabad, India. The label includes storage instructions, NDC number 71610-0129-09, and RX only designation.*

FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Figure 1: Change In Height (cm) From Randomization Visit By Scheduled Week (treatment Group Mean ± Standard (Montelukast Fig1)

A line graph showing change in height (cm) over weeks on treatment for three groups: Montelukast 5 mg, Beclomethasone 336 mcg, and Placebo. The graph includes treatment group means with standard error bars, plotting height changes from -19 to 56 weeks. Montelukast and Beclomethasone groups show positive trends in height change over time compared to placebo.*

FDA Label Image

Figure 2: Fev1 Mean Percent Change From Baseline (u.s. Trial: Montelukast Sodium N=406; Placebo N=270) (anova Model) (Montelukast Fig2)

A line graph depicting mean percent change from baseline in FEV1 over 15 weeks in a U.S. trial comparing Montelukast Sodium (N=406) and placebo (N=270) groups. The x-axis represents weeks in treatment, with a washout period starting at week 12. The y-axis shows mean percent change from baseline in FEV1. Montelukast Sodium shows a higher increase compared to placebo throughout the treatment period.*

FDA Label Image

Chemical Structure (Montelukast Str)

Chemical structure diagram of Montelukast Sodium showing its molecular components including aromatic rings, sulfoxide, cyclopropyl group, and a sodium carboxylate moiety.*

* 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.