Montelukast Sodium Tablet, Film Coated
Product Images NDC 65862-574

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 65862-574). 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.

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Figure 1: Change In Height (cm) From Randomization Visit By Scheduled Week (treatment Group Mean ± Standard (Montelukast Fig1)

The text describes a figure (Figure 1) that shows the change in height (measured in centimeters) over a period of time (from 0 to 56 weeks) for three different treatment groups: Montelukast 5mg (n=120), Beclomethasone 336 mg (n=119), and Placebo (n=121). The mean change in height and standard error of the mean for each group is displayed on the plot. The text also notes that the standard errors of the treatment group means in change in height are too small to be visible on the plot.*

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Figure 2: Fev1 Mean Percent Change From Baseline (u.s. Trial: Montelukast Sodium N=406; Placebo N=270) (anova Model) (Montelukast Fig2)

The text describes a figure (Figure 2) that shows the mean percent change from baseline in FEV (Forced Expiratory Volume) in a U.S. clinical trial involving 40 participants treated with Montelukast Sodium and 270 participants treated with Placebo. The figure presents data for up to 15 weeks in treatment and washout period. The figure legend indicates that statistical analysis has been done using ANOVA Model.*

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Package Label-principal Display Panel (4 mg (30 Tablets Bottle))

NDC 65862-567-30 is a prescription drug named Montelukast Sodium. The drug comes in the form of chewable tablets and used for pediatric patients between 2 to 5 years of age. Each chewable tablet contains 445mg of Montelukast Sodium USP, equivalent to 4 mg Montelukast. The package includes 30 tablets and a medication guide provided by the pharmacist separately. It is advised to keep the drug out of the reach of children and store it in a moisture-free place below 25 C. The drug is manufactured by Aurobindo in India.*

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Package Label-principal Display Panel (5 mg (30 Tablets Bottle))

Montelukast Sodium Chewable Tablets USP is a medication meant for pediatric patients aged 6 to 14 years to prevent asthma or relieve symptoms of allergic rhinitis. Each chewable tablet contains 5.19 mg of montelukast sodium USP. Ensure to dispense the medication guide with the drug to the patient. The medication should be kept out of children's reach and stored at 20° to 25°C (68° to 77°F) in the original package to protect it from moisture and light. The manufacturer of this drug is Aurobindo Pharma USA, Inc., and the drug is made in India. The code TS/DRUGS/22/2009 is printed on the medication package. Not available.*

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Package Label-principal Display Panel (10 mg (30 Tablets Bottle))

This is a description of montelukast sodium tablets distributed in the USA by Aurobindo Pharma. The tablets are used for adults aged 15 and above, as indicated by prescribing information. The medication guide is provided separately to each patient. The tablets are to be stored at room temperature within the original packaging, and protected from moisture and light. Each film-coated tablet contains 10.38 mg of montelukast sodium, equivalent to 10 mg of montelukast. The product is made in India and has a specific code.*

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Package Label-principal Display Panel (10 mg Blister Carton (10 x 10 Unit-dose))

Montelukast Sodium Tablets USP is a medication dispensed by prescription for adults 15 years of age and older. The box contains 7 Aurobindo 100 (10 x 10) unit-dose tablets, each film-coated and equivalent to 10 mg montelukast sodium USP. The usual dosage must be consulted in the prescribing information. The medication should be stored at room temperature, between 20°C to 25°C, and protected from moisture and light. This package is not intended for dispensing and not child-resistant. The distributor of the medication is Aurobindo Pharma USA, located at 278 Princeton-Hightstown Road, East Windsor, NJ 08520.*

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Chemical Structure (Montelukast Str)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.