Nintedanib Capsule
Product Images NDC 68462-803

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Nintedanib (NDC 68462-803). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Glenmark Pharmaceuticals Inc., Usa, 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

Carton100mg60s (Carton100mg60s)

This image shows the packaging label for Nintedanib Capsules 100 mg produced by Glenmark Pharmaceuticals Inc., USA. The carton indicates the product is a prescription-only oral capsule. The package contains 60 capsules with NDC 68462-802-60. Storage information and usage warnings are partially visible on the label.*

FDA Label Image

Carton150mg60s (Carton150mg60s)

Nintedanib Capsules 150 mg carton label distributed by Glenmark Pharmaceuticals Inc., USA. The label includes NDC 68462-803-60 and states that each capsule contains 150 mg nintedanib equivalent to 180.6 mg nintedanib esylate. The package contains 60 capsules and is child-resistant. Storage instructions indicate keeping at 20° to 25°C with excursions permitted to 15° to 30°C. Manufacturer is indicated as a product of Taiwan.*

FDA Label Image

Figure1 (Figure1)

A line graph comparing mean observed FVC change from baseline (mL) over time between placebo and nintedanib 150 mg BID groups. The x-axis represents time points from 2 weeks to 52 weeks, and the y-axis shows mean FVC change from baseline with SEM error bars. Data points indicate FVC decline for each group, with patient numbers listed below each time point.*

FDA Label Image

Figure2 (Figure2)

A survival curve chart comparing the percentage of patients with absolute change in predicted Forced Vital Capacity (FVC) from baseline to week 52. It shows two lines: one for placebo (dotted) and one for nintedanib 150 mg (solid), with percentage marks at specific points along the curves illustrating patient outcomes in improvement and decline of FVC.*

FDA Label Image

Figure3 (Figure3)

A Kaplan-Meier survival curve comparing the estimate of survival (%) over 52 weeks for patients receiving placebo and nintedanib 150 mg twice daily. The chart shows time to death in days on the x-axis and survival percentage on the y-axis, including censored data points. Number at risk for both groups is listed at multiple time points below the graph.*

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Figure4 (Figure4)

A forest plot chart showing the effect of nintedanib 150 mg twice daily versus placebo on the adjusted rate of decline in forced vital capacity (FVC) in milliliters over 52 weeks. The chart includes subgroups: overall population, autoimmune ILDs, hypersensitivity pneumonitis, idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs, with point estimates and 95% confidence intervals for each group.*

FDA Label Image

Figure5 (Figure5)

A line graph comparing mean observed FVC change from baseline over 52 weeks between Nintedanib 150 mg twice daily and placebo. The y-axis measures mean change in FVC (mL) with standard error bars, and the x-axis shows time intervals from 2 to 52 weeks. Data points show Nintedanib resulting in less decline in FVC compared to placebo over time.*

FDA Label Image

Figure6 (Figure6)

A horizontal bar chart comparing proportions of percent change from baseline in FVC at week 52 between placebo and nintedanib 150 mg twice daily groups. The chart shows distribution of patients with varying degrees of improvement and worsening in FVC, indicating 15% had improvement and 85% had worsening or missing data in the placebo group, versus 30% improvement and 70% worsening or missing in the nintedanib group.*

FDA Label Image

Logo (Logo)

FDA Label Image

Logo1 (Logo1)

FDA Label Image

Structure (Structure)

Chemical structure of nintedanib, showing its molecular framework including multiple aromatic rings, amide groups, and sulfonic acid moiety. The diagram depicts atom connectivity without specific labels or bond types beyond standard line notations.*

* 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.