Pirfenidone Tablet, Coated
Product Images NDC 72162-2465

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Pirfenidone (NDC 72162-2465). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bryant Ranch Prepack, 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

Label (Lbl721622465)

Label for Pirfenidone Tablets 267 mg oral coated tablets. The label shows the NDC 72162-2465-2, indicates a total of 270 tablets (3 bottles of 90 tablets each). It is relabeled by Bryant Ranch Prepack and manufactured by Alembic Pharmaceuticals Limited. Storage instructions and QR codes for package insert and dosing information are included.*

FDA Label Image

Figure 1 (Pirfenidone Figure1)

A cumulative distribution graph comparing the absolute change in percentage of forced vital capacity (%FVC) from baseline to week 52 between Pirfenidone (n=278) and placebo (n=277) groups. The x-axis represents change in %FVC ranging from -30% to +10%, while the y-axis shows the percentage of patients from 0% to 100%. Solid line represents Pirfenidone and dotted line represents placebo, with markers indicating percentages of patients experiencing worsening and no decline in %FVC.*

FDA Label Image

Figure 2 (Pirfenidone Figure2)

This chart depicts the mean change in Forced Vital Capacity (FVC) in milliliters over 52 weeks, comparing Pirfenidone (n=278) with placebo (n=277). The x-axis represents time in weeks (0, 13, 26, 39, 52), while the y-axis shows mean change in FVC (mL) ranging from 0 to -500. Pirfenidone shows a slower decline in FVC compared to placebo throughout the study period.*

FDA Label Image

Figure 3 (Pirfenidone Figure3)

A survival curve chart comparing the percentage of patients alive over time in weeks for Pirfenidone (n=623) versus placebo (n=624). The y-axis represents the percentage of patients alive, and the x-axis shows time in weeks up to 120. Lines indicate survival rates, with a hazard ratio (HR) of 0.75 (95% CI: 0.51 to 1.11). Patient risk counts are listed below the chart at various time points for both groups.*

FDA Label Image

Pirfenidone-pi-table1 (Pirfenidone Pi Table 1)

A dosing schedule table for Pirfenidone Tablets 267 mg showing pill counts per day divided into morning, afternoon, and evening doses. It lists three dosing phases: Days 1 to 7 (1 pill each time, total 3 daily), Days 8 to 14 (2 pills each time, total 6 daily), and Days 15 onward (3 pills each time, total 9 daily).*

FDA Label Image

Pirfenidone-pi-table-2 (Pirfenidone Pi Table 2)

A dosing schedule table for Pirfenidone Tablets 801 mg showing the number of tablets to be taken each day starting from Day 15 onward. The table lists one tablet each for morning (breakfast), afternoon (lunch), and evening (dinner), totaling three pills daily.*

FDA Label Image

Pirfenidone (Pirfenidone Structure)

Chemical structure of Pirfenidone, showing a molecular diagram with a phenyl ring connected to a substituted pyridone ring, including a methyl group and a ketone functional group.*

* 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.