Nintedanib Capsule
Product Images NDC 69097-639

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Nintedanib (NDC 69097-639). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Cipla Usa Inc., 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

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A line graph comparing the mean change from baseline in FVC (L) over time between placebo and Nintedanib 150 mg twice daily groups. The x-axis shows time points from baseline to 52 weeks, and the y-axis shows mean FVC change with error bars. The graph includes the number of patients in each group at different time points.*

FDA Label Image

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A Kaplan-Meier curve graph depicting the percentage of patients over time, comparing the effect of Nintedanib 150 mg versus placebo on predicted forced vital capacity (FVC). The x-axis shows absolute change in predicted FVC from baseline to Week 52, and the y-axis shows percentage of patients. Two lines represent the Nintedanib and placebo groups, illustrating trends in improvement and decline in FVC.*

FDA Label Image

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A Kaplan-Meier survival curve showing time to death over 52 weeks (days) comparing Placebo and Nintedanib 150 mg groups. The graph includes a hazard ratio of 0.70 with 95% confidence intervals (0.43 to 1.12). The X-axis represents days, and the Y-axis represents the Kaplan-Meier estimate of survival percentage. A table below the graph shows the number of patients at risk over time for each group.*

FDA Label Image

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

FDA Label Image

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A line graph comparing the mean change in Forced Vital Capacity (FVC) from baseline over time between placebo and Nintedanib 150 mg twice daily groups in patients. The x-axis represents weeks of treatment, and the y-axis shows the mean FVC change in milliliters. Error bars indicate variability, and a patient count at each time point is provided for both groups.*

FDA Label Image

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A horizontal bar chart comparing proportions of improvement and worsening among patients receiving placebo versus Nintedanib 150 mg. The left side shows placebo data with 15% improvement and 85% worsening or missing, while the right side shows Nintedanib 150 mg data with 30% improvement and 70% worsening or missing. The y-axis indicates categories of percent change in some measured variable, and the x-axis shows the proportion percentage.*

FDA Label Image

Bottle-100mg-label-kkb (Bottle 100mg Label Kkb)

Nintedanib Capsules 100 mg oral capsules label showing the Cipla USA Inc. branding. The label indicates a 60-capsule package, with storage instructions and dosage form details. It includes space for batch overprinting of serial number, expiration date, and lot number. Manufactured by Cipla Ltd. in India and labeled by Cipla USA.*

FDA Label Image

Container-150mg-label-kkb (Container 150mg Label Kkb)

Nintedanib Capsules 150 mg oral capsules package label by Cipla USA Inc. The label shows 60 capsules per container, batch info area for serial number, expiry, and lot. It includes storage instructions, manufacturer details in India and the USA, and warnings about child resistance and heat exposure.*

FDA Label Image

Figure-7 (Figure 7)

A line graph comparing the mean observed FVC (forced vital capacity) change from baseline over 52 weeks between placebo and Nintedanib 150 mg taken twice daily (bid). The y-axis shows mean FVC change in milliliters, and the x-axis shows time in weeks. Data points include error bars, and patient numbers are listed below the x-axis for each group.*

FDA Label Image

Figure-8 (Figure 8)

A forest plot comparing the rate of decline in forced vital capacity (FVC) between placebo and Nintedanib 150 mg across various regions (Asia, Europe, Canada and United States, Rest of World) and by baseline Mycophenolate use. The plot shows the difference in adjusted rate of decline with 95% confidence intervals, indicating the effect of Nintedanib 150 mg relative to placebo.*

FDA Label Image

Figure-9 (Figure 9)

A horizontal bar chart comparing percentage change from baseline in FVC (Forced Vital Capacity) between placebo and Nintedanib 150 mg groups. The chart displays proportions of patients with various levels of improvement and worsening, highlighting 26% improvement in placebo versus 38% in Nintedanib, and 74% worsening or missing data in placebo versus 62% in Nintedanib.*

FDA Label Image

Structure (Structure)

Chemical structure of Nintedanib, showing its molecular framework with multiple rings and functional groups including methoxy, sulfonyl, amide, and piperazine moieties.*

* 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.