Montelukast Sodium
Product Images NDC 54868-6362

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 54868-6362). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Physicians Total Care, Inc., 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) (26dd1d17 C192 456a Af9b 307d3231363c 01)

A line chart depicting change in height (cm) over weeks on treatment for three groups: Montelukast 5 mg, Beclomethasone 336 mcg, and placebo. The x-axis shows weeks on treatment from -19 to 56, and the y-axis shows change in height from -3 to 7 cm. Montelukast and Beclomethasone groups show positive height change over time compared to placebo.*

FDA Label Image

Montelukast Sodium Structural Formula (26dd1d17 C192 456a Af9b 307d3231363c 02)

Chemical structure of Montelukast Sodium, showing its molecular components including a chlorinated aromatic ring, sulfur atom, cyclopropyl group, and sodium carboxylate moiety as part of the active ingredient's detailed chemical diagram.*

FDA Label Image

Figure 2: Fev1 Mean Percent Change From Baseline (u.s. Trial: Montelukast Sodium N = 406; Placebo N = 270) (anova Model) (26dd1d17 C192 456a Af9b 307d3231363c 03)

A line graph showing mean percent change from baseline over weeks in treatment comparing Montelukast Sodium to placebo. The x-axis represents weeks in treatment from 0 to 15, and the y-axis shows mean percent change from baseline. The graph includes error bars and distinguishes between Montelukast Sodium and placebo responses, including a washout period indicated by dashed lines.*

FDA Label Image

Montelukast Sodium Tablets 10 mg Label (6361)

Packaging label for Montelukast Sodium 10 mg by Physicians Total Care, Inc. The label includes the NDC number 54858-6361-08, lot number 0000, and an expiration date listed as 01/60. A barcode is also present on the label.*

FDA Label Image

Montelukast Sodium Chewable Tablets 5 mg Label (6362)

Montelukast Sodium 5 mg chewable tablets packaging label distributed by Physicians Total Care, Inc. The label shows a lot number, expiration date, and includes a barcode. The package contains 30 tablets.*

FDA Label Image

Montelukast Sodium Chewable Tablets 4 mg Label (6363)

Montelukast Sodium 4 mg chewable tablets label from Physicians Total Care, Inc. The label is for use in pediatric patients aged 2 to 5 years and includes 60 tablets per container. It contains regulatory and dispensing cautions and a barcode with lot number and expiration date 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.