Montelukast Sodium
Product Images NDC 43353-879

5 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 43353-879). 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 (43353 879)

Bottle Label 10mg (43353 879)
Label for Montelukast Sodium (Montelukast NA) 10 mg tablets, containing 9000 tablets. The label states storage instructions and repackaging information by Aphena Pharma Solutions - Tennessee, LLC, with manufacturing by Kremers Urban Pharmaceuticals Inc. The product is prescription only and includes several barcodes and batch lot information areas.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Figure 1 (Montelukast 01)

Figure 1 (Montelukast 01)
A line graph showing change in height (cm) over weeks on treatment for three groups: Montelukast Sodium 5 mg, Beclomethasone 336 mcg, and Placebo. The graph plots height changes from week -19 to 56 with different markers representing each treatment group.*
FDA Label Image

Chemical Structure (Montelukast 02)

Chemical Structure (Montelukast 02)
Chemical structure of Montelukast Sodium, depicting the molecular arrangement including chlorinated bicyclic, sulfur-containing, and carboxylate sodium salt groups.*
FDA Label Image

Figure 2 (Montelukast 03)

Figure 2 (Montelukast 03)
A line graph showing mean percent change from baseline over weeks in treatment for Montelukast Sodium and placebo groups. Data points for Montelukast Sodium are higher than placebo throughout, with a washout period indicated 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.