Montelukast Sodium Granule
Product Images NDC 59651-329

5 FDA label images from Aurobindo Pharma Limited · 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 59651-329). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma 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

Figure1 (Montelukast Fig1)

Figure1 (Montelukast Fig1)
A line graph showing 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 represents change in height from -3 to 7 cm. Lines indicate growth trends for each treatment group with Montelukast and Beclomethasone closely following and Placebo not separately depicted. Standard errors are noted as too small to be visible on the plot.*
FDA Label Image

Figure2 (Montelukast Fig2)

Figure2 (Montelukast Fig2)
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, extending to a washout period after 12 weeks. The y-axis shows mean percent change, ranging from 0 to 15. Montelukast Sodium shows a higher percent change compared to placebo throughout treatment, with values peaking near week 12 before a decline during washout.*
FDA Label Image

Package Label-principal Display Panel (4 mg (Packet))

Package Label-principal Display Panel (4 mg (Packet))
Montelukast Sodium Oral Granules USP 4 mg packet packaging label from Aurobindo Pharma Limited. The label is for pediatric patients 6 months to 5 years old and includes NDC 59651-329. It lists excipients and contains pharmacist instructions to dispense the Medication Guide separately. The label has opening instructions and a barcode.*
FDA Label Image

Package Label-principal Display Panel (4 mg (30 Packet Carton))

Package Label-principal Display Panel (4 mg (30 Packet Carton))
Montelukast Sodium Oral Granules USP 4 mg carton label by Aurobindo Pharma Limited. The label indicates the product is for oral use, contains 30 packets of 4 mg granules, and is intended for pediatric patients 6 months to 5 years. It includes dispensing instructions and storage details. The NDC is 59651-329-30 and the product is distributed by Aurobindo Pharma USA, Inc.*
FDA Label Image

Chemical Structure (Montelukast Str)

Chemical Structure (Montelukast Str)
Chemical structure of montelukast sodium, showing its molecular arrangement including aromatic rings, a chlorine atom, sulfur atom, and a sodium carboxylate group.*

* 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.