Nintedanib Capsule
Product Images NDC 42799-972

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Nintedanib (NDC 42799-972). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Edenbridge Pharmaceuticals Llc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

Product Images & Figures Index

FDA Label Image

1 (100mg Bottle Label)

1 (100mg Bottle Label)
Label for Nintedanib Capsules 100 mg by Edenbridge Pharmaceuticals LLC. The label shows a 60-capsule count, with storage instructions including temperature ranges and warnings against chewing or opening capsules. The distributor is listed as Edenbridge Pharmaceuticals, DBA Dexcel Pharma USA, Parsippany, NJ.*
FDA Label Image

1 (150mg Bottle Label)

1 (150mg Bottle Label)
Nintedanib Capsules 150 mg bottle label, showing the drug name, strength, quantity of 60 capsules, and manufacturer Edenbridge Pharmaceuticals LLC. The label includes dosage form as capsules and storage instructions, with the distributor listed as Dexcel Pharma USA, Parsippany, NJ.*
FDA Label Image

1 (Figure 1)

1 (Figure 1)
A line graph charting mean (SEM) observed FVC (Forced Vital Capacity) change from baseline (mL) over 52 weeks in Study 2 comparing placebo and Nintedanib 150 mg twice daily. The graph includes error bars, shows the number of patients at each time point, and illustrates changes measured at 2, 4, 6, 12, 24, 36, and 52 weeks.*
FDA Label Image

1 (Figure 2)

1 (Figure 2)
A cumulative distribution graph depicting the percentage of patients by change in percent predicted Forced Vital Capacity (FVC) from baseline to Week 52. The x-axis represents the absolute change in percent predicted FVC, ranging from improvement to decline, and the y-axis shows the percentage of patients. Two groups are compared: Placebo and Nintedanib 150 mg twice daily (150bid), with vertical lines indicating 0% and 10% decline thresholds.*
FDA Label Image

1 (Figure 3)

1 (Figure 3)
Kaplan-Meier survival curve chart estimating all-cause mortality at the end of study for Study 2 and Study 3 comparing Nintedanib 150 mg twice daily (bid) versus placebo over 52 weeks. The y-axis shows Kaplan-Meier estimate of survival percentage, and the x-axis shows time to death in days. The chart includes hazard ratio and 95% confidence interval, with a risk table indicating the number of subjects at risk over time. Censored data points are marked on the graph.*
FDA Label Image

1 (Figure 4)

1 (Figure 4)
A figure titled 'Annual Rate of Decline in FVC (mL) over 52 Weeks based on Underlying ILD Diagnosis in Study 5' showing a forest plot comparing placebo and nintedanib 150mg BID groups. The chart presents the rate of decline in forced vital capacity (FVC) across various interstitial lung disease (ILD) subtypes with sample sizes and 95% confidence intervals, illustrating treatment effect differences.*
FDA Label Image

1 (Figure 5)

1 (Figure 5)
A line graph showing mean (SEM) observed forced vital capacity (FVC) change from baseline in milliliters over 52 weeks from Study 5. Two groups are compared: placebo (dashed line) and nintedanib 150 mg twice daily (solid line). The graph shows FVC changes measured at multiple intervals from 2 to 52 weeks with patient numbers listed below each time point.*
FDA Label Image

1 (Figure 6)

1 (Figure 6)
A histogram showing the percent change in forced vital capacity (FVC) from baseline to week 52, comparing placebo and Nintedanib 150 mg taken twice daily (bid). The chart displays proportions of patients with different ranges of percent change in FVC, indicating improvement, worsening, or missing data. Placebo and Nintedanib groups are differentiated by shading.*
FDA Label Image

1 (Nintedanib Esylate)

1 (Nintedanib Esylate)
Chemical structure diagram of nintedanib, showing its molecular composition and arrangement as a chemical compound used in the drug product Nintedanib capsules by Edenbridge Pharmaceuticals LLC.*
FDA Label Image

1 (Table 1)

1 (Table 1)
A data table showing adverse reactions occurring in 5% or more of patients treated with 150 mg Nintedanib capsules compared to placebo in clinical studies for idiopathic pulmonary fibrosis. The table lists reaction categories such as gastrointestinal disorders, hepatobiliary disorders, metabolism and nutrition disorders, nervous system disorders, investigations, and vascular disorders, with corresponding percentages for Nintedanib and placebo groups.*
FDA Label Image

1 (Table 3)

1 (Table 3)
A data table titled 'Annual Rate of Decline in FVC (mL) in Study 1, Study 2, and Study 3' comparing nintedanib capsules 150 mg twice daily with placebo across three studies. The table presents the number of analyzed patients, the rate of decline over 52 weeks, and comparison differences versus placebo including 95% confidence intervals.*
FDA Label Image

1 (Table 4)

1 (Table 4)
A data table titled 'Annual Rate of Decline in FVC (mL) in Study 5' comparing the effects of Nintedanib capsules versus placebo on forced vital capacity (FVC) decline. The table includes data for overall patients, UIP-like subpopulation, and other HRCT subpopulation, listing number of analyzed patients, adjusted annual rate of decline over 52 weeks, and comparison versus placebo difference with 95% confidence intervals.*

* 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.