Pirfenidone Tablet, Film Coated
Product Images NDC 82249-116

7 FDA label images from Civica Script Llc · 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 82249-116). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Civica Script Llc, 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 (Structure)

Structure (Structure)
Chemical structure of pirfenidone, showing its molecular arrangement with a pyridone ring, a benzene ring, and a methyl group.*
FDA Label Image

Pirfenidonetabfigure1 (Pirfenidonetabfigure1)

Pirfenidonetabfigure1 (Pirfenidonetabfigure1)
A cumulative percentage graph comparing the absolute change in % predicted forced vital capacity (FVC) from baseline to week 52 between Pirfenidone and placebo groups. The x-axis shows change in %FVC, ranging from -30% to +10%. The y-axis indicates the percentage of patients, from 0% to 100%. The graph includes lines for Pirfenidone (n=278) and placebo (n=277), with marked percentages at specific points for each group, illustrating patient worsening and no decline in %FVC.*
FDA Label Image

Pirfenidonetabfigure2 (Pirfenidonetabfigure2)

Pirfenidonetabfigure2 (Pirfenidonetabfigure2)
A line graph comparing mean change in Forced Vital Capacity (FVC) over 52 weeks between Pirfenidone and placebo groups. The x-axis represents time in weeks (0, 13, 26, 39, 52), and the y-axis shows mean change in FVC in mL, with Pirfenidone group represented by a solid line and placebo by a dashed line, indicating a slower decline in FVC for the Pirfenidone group.*
FDA Label Image

Pirfenidonetabfigure3 (Pirfenidonetabfigure3)

Pirfenidonetabfigure3 (Pirfenidonetabfigure3)
A Kaplan-Meier survival curve showing the percentage of patients alive over time (weeks) comparing Pirfenidone (n=278) and placebo (n=624). The graph includes a hazard ratio (HR) with 95% confidence interval indicating relative survival between groups. A table below shows patient counts at risk at different time points for both Pirfenidone and placebo groups.*
FDA Label Image

Pirfenidonetablets-267mg90containerlabel (Pirfenidonetablets 267mg90containerlabel)

Pirfenidonetablets-267mg90containerlabel (Pirfenidonetablets 267mg90containerlabel)
Label for Pirfenidone Tablets, USP 267 mg film-coated tablets, distributed by CivicaScript LLC. The label indicates a package of 90 tablets, including storage instructions and a barcode. It includes manufacturer details from Annora Pharma Pvt. Ltd., India, and a QR code for more information.*
FDA Label Image

Pirfenidonetablets-267mg90cartonlabel (Pirfenidonetablets 267mg90cartonlabel)

Pirfenidonetablets-267mg90cartonlabel (Pirfenidonetablets 267mg90cartonlabel)
Pirfenidone Tablets, USP 267 mg film-coated tablets label showing packaging for 270 tablets (three bottles of 90 tablets each). The label includes dosage strength, storage instructions (store at 20 to 25°C), and manufacturer information: distributed by CivicaScript LLC, Lehi, Utah, and manufactured by Annora Pharma Pvt Ltd, Telangana, India. The NDC code 82249-115-27 is displayed, along with a barcode.*
FDA Label Image

Pirfenidonetablets-801mg90containerlabel (Pirfenidonetablets 801mg90containerlabel)

Pirfenidonetablets-801mg90containerlabel (Pirfenidonetablets 801mg90containerlabel)
Label for Pirfenidone Tablets, USP 801 mg film-coated oral tablets by Civica Script LLC. The label indicates a package containing 90 tablets and includes storage instructions between 20°C to 25°C. The product is distributed by Civica Script LLC and manufactured by Annora Pharma Pvt. Ltd. in India. A barcode and QR code for more product information are also present.*

* 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.