Pirfenidone Capsule
Product Images NDC 0781-2158

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Pirfenidone (NDC 0781-2158). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sandoz 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

Structure (Pirfenidone 01)

Chemical structure diagram of the active ingredient pirfenidone, showing its molecular configuration with aromatic rings and functional groups clearly depicted.*

FDA Label Image

Figure 1 (Pirfenidone 02)

A line graph comparing the percentage of patients treated with Pirfenidone versus placebo, showing absolute change in percent predicted forced vital capacity (%FVC) from baseline to week 52. The x-axis represents change in %FVC from -30% to 10%, and the y-axis shows percentage of patients from 0 to 100%. The graph highlights 77% of Pirfenidone patients and 90% of placebo patients experiencing no decline or increase in %FVC, with 17% and 32% respectively showing worsening (%FVC decrease).*

FDA Label Image

Figure 2 (Pirfenidone 03)

Line graph showing the mean change in Forced Vital Capacity (FVC) in milliliters over 52 weeks. Two groups are compared: one receiving Pirfenidone (n=278) and the other a placebo (n=277). The Pirfenidone group shows a slower decline in FVC compared to the placebo group throughout the study period.*

FDA Label Image

Figure 3 (Pirfenidone 04)

A survival curve chart comparing the percentage of patients remaining at risk over time (in weeks) for two groups: Pirfenidone 267 mg capsule and placebo. The x-axis represents time in weeks from 0 to 120, and the y-axis shows the percent survival area from 0 to 100. Patient numbers at risk for each group are listed below the x-axis at multiple time points. A hazard ratio and confidence interval are provided in the legend.*

FDA Label Image

Table.jpg (Pirfenidone 06)

A dosing schedule table for Pirfenidone Capsules 267 mg. It details the number of capsules to take in the morning, afternoon, and evening over three time periods: Days 1-7 (1 capsule each time, total 3 daily), Days 8-14 (2 capsules each time, total 6 daily), and Days 15 onward (3 capsules each time, total 9 daily).*

FDA Label Image

Label (Image 01)

Label for Pirfenidone Capsules 267 mg, an oral prescription medication by Sandoz Inc. The label states the package contains 270 capsules and includes storage instructions and safety warnings. The label notes the product is manufactured by Lek Pharmaceuticals in Slovenia and is a product of India.*

* 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.