Montelukast Sodium
Product Images NDC 71610-051

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 71610-051). 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 10mg (71610 0051 30)

Montelukast Sodium 10 mg tablet bottle label displaying the product name, strength, and quantity of 30 tablets. The label includes storage instructions, manufacturer information (Spring Valley, NY), and repackager details (Aphena Pharma Solutions - Tennessee, LLC). The product is marked for prescription use only with an NDC number 71610-0051-30.*

FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Figure 1 (Montelukast Sodium 1)

A line graph showing change in height (cm) over weeks on treatment for three groups: SINGULAIR 5 mg, Beclomethasone 336 mcg, and Placebo. The x-axis represents weeks on treatment, ranging from -20 to 60, and the y-axis shows height change from -3 to 7 cm. The graph includes standard error bars for the SINGULAIR group.*

FDA Label Image

Chemical Structure Of Montelukast Sodium (Montelukast Sodium 2)

Chemical structure of montelukast sodium, showing the molecular arrangement of atoms including chlorine, sulfur, sodium carboxylate, and various aromatic rings, consistent with the active ingredient Montelukast Sodium.*

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 showing mean percent change from baseline over weeks in treatment for Montelukast Sodium versus placebo. The x-axis represents weeks in treatment up to 15 weeks, including a washout period, while the y-axis shows mean percent change. Montelukast Sodium data points are marked with black circles, consistently higher than placebo marked with open squares.*

* 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.