Pirfenidone Tablet, Film Coated
Product Images NDC 0781-8086

7 FDA label images from Sandoz Inc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Pirfenidone (NDC 0781-8086). 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)

Structure (Pirfenidone 01)
Chemical structure of pirfenidone, showing a pyridone ring with a methyl group and a phenyl group attached.*
FDA Label Image

Fig-1 (Pirfenidone 02)

Fig-1 (Pirfenidone 02)
A line graph comparing the percentage of patients with changes in %FVC from baseline to week 52 between Pirfenidone and placebo groups. The x-axis shows absolute change in %FVC ranging from -30% to 10%, and the y-axis shows the percentage of patients from 0% to 100%. The graph indicates worsening (decrease in %FVC) to the left and no decline (increase in %FVC) to the right, with notable data points at 17% for Pirfenidone and 32% for placebo at -10% change, and 77% for Pirfenidone and 90% for placebo at 0% change in %FVC.*
FDA Label Image

Fig-2 (Pirfenidone 03)

Fig-2 (Pirfenidone 03)
A line graph depicting mean change in forced vital capacity (FVC) in milliliters over a 52-week period. The graph compares two groups: one treated with Pirfenidone (solid line) and a placebo group (dashed line), showing the trend in FVC decline over time for each group.*
FDA Label Image

Fig-3 (Pirfenidone 04)

Fig-3 (Pirfenidone 04)
A Kaplan-Meier curve chart comparing the integrated pirfenidone axis survival or response over time (in weeks) between Pirfenidone and placebo groups. It shows two lines representing data for 623 patients on Pirfenidone and 274 on placebo, along with risk numbers at various time points (0, 26, 52, 78, and 104 weeks).*
FDA Label Image

Dosing-schedule (Pirfenidone 05)

Dosing-schedule (Pirfenidone 05)
Text panels showing dosing schedules for Pirfenidone tablets in 267 mg and 801 mg strengths. The 267 mg schedule shows increasing pill counts over the first two weeks and stabilizing at nine pills daily from day 15 onward. The 801 mg schedule shows three pills daily from day 15 onward. Instructions note the 801 mg tablets are dark pink film-coated tablets taken three times daily.*
FDA Label Image

267mg-label (Image 01)

267mg-label (Image 01)
Pirfenidone Tablets 267 mg film-coated, oral dosage form, with 270 tablets per bottle. The label is from Sandoz Inc. It includes storage instructions at 25°C with permitted excursions and a warning to keep the product out of reach of children. The label also specifies that the product is prescription only.*
FDA Label Image

801mg-label (Image 02)

801mg-label (Image 02)
Pirfenidone 801 mg film-coated tablets packaging label. Contains 90 tablets, for oral use, labeled as prescription only. The label displays the Sandoz Inc. logo and provides storage instructions, dosage information, and safety warnings including keeping the product out of reach of children.*

* 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.