Nintedanib Capsule
Product Images NDC 60505-4819

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Nintedanib (NDC 60505-4819). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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

Btl-lbl-100mg.jpg (Btl Lbl 100mg)

Label for Nintedanib 100 mg capsules by Apotex Corp. The label states the package contains 60 capsules. It includes storage instructions, dosage caution, and manufacturer details for Softgel Healthcare Private Limited in India. The label highlights that each capsule contains 100 mg nintedanib equivalent to 120.40 mg nintedanib esylate. A barcode and the Rx symbol are also present.*

FDA Label Image

Btl-lbl-150mg.jpg (Btl Lbl 150mg)

Nintedanib Capsules 150 mg oral capsules label from Apotex Corp., containing 60 capsules. The label includes storage instructions, dosage cautions, and manufacturer information for Softgel Healthcare Private Limited in India, with a bar code and NDC 60505-4819-6.*

FDA Label Image

Figure1.jpg (Figure1)

A line graph comparing mean (SEM) observed forced vital capacity (FVC) change from baseline (mL) over time between placebo and Nintedanib 150 mg twice daily (bid) groups across 2, 4, 6, 12, 24, 36, and 52 weeks. The graph includes patient numbers for each group at each time point below the x-axis.*

FDA Label Image

Figure2.jpg (Figure2)

A line chart depicting the percentage of patients over absolute change in predicted FVC from baseline to Week 52. It compares two groups: Placebo (N=204) with a dotted line and Nintedanib 150 mg (N=309) with a solid line. The x-axis ranges from -10 to 30, indicating improvement or decline in FVC, while the y-axis shows the percentage of patients from 0 to 100%. Percentage milestones such as 70%, 82%, 29%, and 43% are marked along the curves.*

FDA Label Image

Figure3.jpg (Figure3)

A Kaplan-Meier survival curve graph showing the estimated survival percentage over 52 weeks (days) comparing Nintedanib 150 mg twice daily (bid) versus placebo. The graph includes a legend and hazard ratio with 95% confidence interval. Sample sizes at risk are shown below the x-axis for both groups.*

FDA Label Image

Figure4.jpg (Figure4)

A forest plot showing 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. The chart includes overall population and subgroups such as autoimmune ILDs, hypersensitivity pneumonitis, idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs, with estimates and 95% confidence intervals.*

FDA Label Image

Figure5.jpg (Figure5)

A line graph showing mean observed FVC (forced vital capacity) change from baseline over 52 weeks comparing Nintedanib 150 mg twice daily (150bid) and placebo. The y-axis represents the mean change in FVC (mL) and the x-axis represents time points from 2 to 52 weeks. Data points with error bars indicate variability, and a table below the graph shows the number of patients at each time point for both treatment groups.*

FDA Label Image

Figure6.jpg (Figure6)

A horizontal paired bar chart comparing the percent change from baseline in FVC (mL) at week 52 between Placebo and Nintedanib 150 mg twice daily (bid). The chart shows proportions of patients with improvement, worsening or missing data, with improvement seen in 15% of placebo and 30% of Nintedanib-treated patients, and worsening or missing data seen in 85% of placebo and 70% of Nintedanib-treated patients.*

FDA Label Image

Structure.jpg (Structure)

Chemical structure of the active ingredient Nintedanib, showing its molecular arrangement and various functional groups depicted in a structural diagram.*

* 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.