Nintedanib Capsule
Product Images NDC 73190-097

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Nintedanib (NDC 73190-097). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avkare, 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

1 (096 60)

The packaging label for nintedanib capsules, 100 mg strength, manufactured by AvKARE. The label features the product name prominently, with dosage form as capsules and the package size of 60 capsules. It includes storage instructions, a barcode, and the labeler information located in Pulaski, TN.*

FDA Label Image

1 (097 60)

Nintedanib Capsules 150 mg oral capsules package label by AvKARE. The label indicates 60 capsules per package with Rx only status. It includes a red dosage strength indicator and dosage warnings, handling instructions, and manufacturer details, including contact information and barcode.*

FDA Label Image

Figure1 (Figure1)

A line graph depicting mean observed forced vital capacity (FVC) change from baseline over time in milliliters for placebo and nintedanib 150 mg twice daily (bid) groups. The x-axis shows study time points from 2 to 52 weeks, and the y-axis shows mean FVC change. Data points include standard error of the mean (SEM) error bars. Patient numbers for each group at various weeks are listed below the graph.*

FDA Label Image

Figure2 (Figure2)

A line graph comparing the percentage of patients experiencing changes in predicted forced vital capacity (FVC) from baseline to Week 52. The x-axis represents the absolute change in % predicted FVC, divided into improvement and decline zones. Two lines, one for placebo (dotted) and one for nintedanib 150 mg (solid), show patient response distributions, with annotated percentages indicating patient proportions at key points along the curves.*

FDA Label Image

Figure3 (Figure3)

A Kaplan-Meier survival curve showing time to death over 52 weeks comparing nintedanib 150 mg twice daily (bid) versus placebo. The y-axis represents Kaplan-Meier estimate of survival (%) and the x-axis represents days. The graph includes a hazard ratio of 0.70 (95% CI: 0.43 to 1.12) and denotes censored data points. Number at risk for placebo and nintedanib groups are listed below the x-axis.*

FDA Label Image

Figure4 (Figure4)

A forest plot chart comparing the difference in adjusted rate of decline in FVC (mL) over 52 weeks between nintedanib 150 mg twice daily and placebo across various interstitial lung disease (ILD) populations, including overall population, autoimmune ILDs, hypersensitivity pneumonitis, idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. The chart includes point estimates with 95% confidence intervals for each subgroup.*

FDA Label Image

Figure5 (Figure5)

A line graph comparing the mean observed forced vital capacity (FVC) change from baseline over time between placebo and nintedanib 150 mg twice daily. The x-axis shows weeks from 2 to 52, and the y-axis shows mean FVC change in mL. Data points with error bars are plotted for both groups, showing a decline in FVC, with less decline in the nintedanib group. Patient numbers at each time point are listed below the graph for both groups.*

FDA Label Image

Figure6 (Figure6)

A horizontal bar chart comparing the percent change from baseline in FVC (mL) at week 52 between placebo and nintedanib 150 mg twice daily. It shows proportions of patients with improvement, worsening, or missing data, with 15% improvement for placebo versus 30% for nintedanib, and 85% worsening or missing for placebo versus 70% for nintedanib.*

FDA Label Image

Structure (Structure)

Chemical structure of nintedanib, showing its molecular framework including aromatic rings, amide groups, and a sulfonic acid 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.