Montelukast Sodium
Product Images NDC 64380-258

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 64380-258). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Strides Pharma Science Limited, 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

Graph 1 (Db92eb61 1331 4f8a A5a8 329dd9354c62 01)

A line graph comparing the change in height (cm) over weeks on treatment for Montelukast 5 mg, Beclomethasone 336 mcg, and placebo groups. The x-axis represents weeks on treatment from -19 to 56, and the y-axis shows change in height ranging from -3 to 7 cm. The graph includes three trend lines for each group with corresponding sample sizes: Montelukast (n=120), Beclomethasone (n=119), and placebo (n=121).*

FDA Label Image

Structural Formula (Db92eb61 1331 4f8a A5a8 329dd9354c62 02)

Chemical structure of Montelukast Sodium, showing its molecular framework including aromatic rings, a chlorine atom, a sulfur atom, and a sodium carboxylate group, consistent with its depiction in pharmaceutical drug labeling.*

FDA Label Image

Graph 2 (Db92eb61 1331 4f8a A5a8 329dd9354c62 03)

A line chart comparing mean percent change from baseline over weeks in treatment between Montelukast Sodium and placebo groups. The x-axis represents weeks in treatment, including a washout period from week 12 to 15. The y-axis represents mean percent change from baseline, with Montelukast Sodium showing a higher increase compared to placebo throughout the treatment period.*

FDA Label Image

10 mg (Db92eb61 1331 4f8a A5a8 329dd9354c62 04)

Montelukast Sodium Tablets, USP 10 mg package label showing dosage strength, quantity of 30 tablets, and Rx only designation. Label includes storage instructions, pharmacy dispensing note, and manufacturer as Strides Pharma Science Limited. Barcode and NDC code 64380-256-01 are visible.*

FDA Label Image

4mg (Db92eb61 1331 4f8a A5a8 329dd9354c62 05)

Montelukast Sodium Chewable Tablets, USP 4 mg tablet strength label from Strides Pharma Science Limited. The label indicates 30 tablets per package, noting the active ingredient amount and storage instructions. It specifies use for pediatric patients 2-5 years, includes pharmacist dispensing information, and features the product NDC 64380-257-01 and barcode.*

FDA Label Image

5mg (Db92eb61 1331 4f8a A5a8 329dd9354c62 06)

Montelukast Sodium 5 mg chewable tablets, USP label from Strides Pharma Inc. The package contains 30 tablets and is marked Rx only. It includes pediatric dosing information for ages 6-14 years and instructions to see the package insert for usual dosage. Storage instructions specify 25°C with permitted excursions and protection from moisture and light. The label also includes a barcode and a note for pharmacists to dispense accompanying patient 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.