Ofev Capsule
Product Images NDC 0597-0143

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Ofev (NDC 0597-0143). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Boehringer Ingelheim Pharmaceuticals, 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.

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Chemical Structure (Ofev 01)

Chemical structure diagram of the active ingredient nintedanib, showing its molecular connectivity including aromatic rings, amide groups, and sulfonyl moiety.*

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Figure 1 (Ofev 02)

A line graph comparing mean observed FVC change from baseline (mL) over time between placebo and nintedanib 150 mg twice daily (bid) groups. The X-axis shows time points from 2 to 52 weeks, and the Y-axis shows the mean FVC change with error bars. Patient numbers are listed below for each time point by group.*

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Figure 2 (Ofev 03)

A Kaplan-Meier style curve graph showing the percentage of patients over absolute change in predicted forced vital capacity (FVC) from baseline to Week 52 for Ofev (nintedanib 150 mg bid) compared to placebo. The graph indicates improvement and decline in FVC, with patient percentages and specific values marked at various points.*

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Figure 3 (Ofev 04)

A Kaplan-Meier survival curve graph showing the estimate of survival percentage over 52 weeks (days) for two groups: Placebo and Nintedanib 150 mg, with censored data points indicated. The chart includes a hazard ratio of 0.70 with a 95% confidence interval (0.43, 1.12) and a table of the number of patients at risk over time for both groups.*

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Figure 4 (Ofev 04a)

A chart showing the difference in adjusted rate of decline in forced vital capacity (FVC) over 52 weeks between placebo and Nintedanib 150 mg twice daily (150bid) for various groups with interstitial lung disease (ILD). The chart includes the overall population and subgroups: autoimmune ILDs, hypersensitivity pneumonitis, idiopathic nonspecific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. Data are presented with sample sizes, estimate values, and 95% confidence intervals, visually represented by dots and horizontal error bars indicating confidence intervals against a vertical axis.*

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Figure 5 (Ofev 04b)

A line graph showing mean observed forced vital capacity (FVC) change from baseline over 52 weeks comparing nintedanib 150 mg twice daily versus placebo. The graph plots FVC change in mL on the y-axis and time in weeks on the x-axis, with data points and error bars for each group. Patient numbers per time point are listed below the x-axis.*

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Figure 6 (Ofev 04c)

A horizontal bar chart comparing percent change in FVC (mL) at Week 52 from baseline between placebo and Nintedanib 150mg twice daily (150bid). Percentages of patients with various levels of improvement, worsening, or missing data are shown, with placebo group having 15% improvement and 85% worsening or missing, and Nintedanib group having 30% improvement and 70% worsening or missing.*

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Figure 7 (Ofev 05)

A line graph illustrating mean observed FVC (mL) change from baseline over time comparing placebo and Nintedanib 150 mg twice daily. The x-axis shows time points from 2 to 52 weeks, and the y-axis shows mean FVC change with error bars. Data points for placebo are dotted lines with open circles, and Nintedanib is solid lines with filled circles, accompanied by patient numbers at each time point.*

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Figure 8 (Ofev 06)

A forest plot chart comparing the rate of decline in adjusted FVC (mL/yr) between placebo and Nintedanib 150 mg twice daily across different regions and baseline mycophenolate use. The plot shows point estimates and 95% confidence intervals for the difference in decline rate, comparing favorability towards placebo or Nintedanib 150 mg bid.*

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Figure 9 (Ofev 07)

A horizontal bar chart comparing the percent change from baseline in forced vital capacity (FVC) at Week 52 between Placebo and Nintedanib 150 mg twice daily groups. The chart shows proportions of patients (%) in various percent change ranges, indicating 26% improvement and 74% worsening or missing in Placebo, versus 38% improvement and 62% worsening or missing in Nintedanib 150 mg groups.*

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Image (Ofev 08)

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Principal Display Panel (150 mg Capsule Bottle Carton)

Ofev 150 mg capsules packaging label featuring the proprietary name, generic name nintedanib, strength, and dosage form. The label states the quantity of 60 capsules and includes storage instructions, distributor and manufacturer details (Boehringer Ingelheim Pharmaceuticals, Inc.), barcode, and additional regulatory information. The capsule is labeled for prescription use only.*

FDA Label Image

Principal Display Panel (100 mg Capsule Bottle Carton)

Packaging label for Ofev 100 mg capsules (nintedanib) by Boehringer Ingelheim Pharmaceuticals, Inc. The label shows the product name, strength, dosage form (capsules), quantity (60 capsules), and manufacturer information. It includes storage instructions, dosage advising to see package insert, a barcode, and distributor details noting the product is made in Germany.*

* 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.