Pirfenidone Tablet, Coated
Product Images NDC 69097-988

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Pirfenidone (NDC 69097-988). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Cipla Usa 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

Figure 1 (Pirfenidone Figure1)

A cumulative distribution plot showing the percentage of patients versus absolute change in %FVC from baseline to week 52. The graph compares Pirfenidone (n=278) and placebo (n=277) groups, highlighting proportions of patients with worsening (decrease in %FVC) and no decline (increase in %FVC). The plot shows 32% of placebo patients and 17% of Pirfenidone patients experiencing a decline greater than 10% in %FVC, with 77% of Pirfenidone and 90% of placebo patients showing no decline or improvement at week 52.*

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Figure 2 (Pirfenidone Figure2)

A line graph depicting mean change in FVC (mL) over 52 weeks, comparing Pirfenidone (n=278) and Placebo (n=277). The x-axis shows weeks (0, 13, 26, 39, 52) and the y-axis shows mean change in FVC, with Pirfenidone represented by a solid line and Placebo by a dashed line, demonstrating less decline in FVC for Pirfenidone over time.*

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Figure 3 (Pirfenidone Figure3)

A Kaplan-Meier survival curve comparing the percentage of patients alive over time (up to 120 weeks) between Pirfenidone and placebo groups. The graph includes the number of patients at risk at various time points and shows hazard ratio (HR) with 95% confidence interval.*

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267 mg (Pirfenidone Pdp 1)

Label for Pirfenidone Tablets 267 mg oral film-coated tablets. The label indicates a package of 90 tablets manufactured for Cipla USA, Inc. and by ScieGen Pharmaceuticals, Inc. Storage instructions and a barcode are also present.*

FDA Label Image

267 mg (Pirfenidone Pdp 2)

Pirfenidone Tablets 267 mg tablet label showing the quantity of 270 coated tablets. The label includes storage instructions, manufacturer information, and a barcode. Manufactured for Cipla USA Inc. and by ScieGen Pharmaceuticals, Inc.*

FDA Label Image

801 mg (Pirfenidone Pdp 5)

Label for Pirfenidone Tablets 801 mg, oral coated tablets, containing 90 tablets. The label includes dosage information, storage instructions, and identification of Cipla USA Inc. as the labeler and ScieGen Pharmaceuticals as the manufacturer. The label also features a barcode and NDC 69097-988-05.*

FDA Label Image

801 mg (Pirfenidone Pdp 6)

Pirfenidone Tablets 801 mg film-coated tablet label showing the strength and quantity of 270 tablets. The label includes storage instructions, manufacturer details (Cipla USA, Inc. and ScieGen Pharmaceuticals, Inc.), and a barcode. The label indicates Rx only status and no varnish on the tablet.*

FDA Label Image

Pirfenidone (Pirfenidone Structure)

Chemical structure of Pirfenidone, showing two connected aromatic rings, one of which contains a ketone group and a methyl substitution, consistent with the compound's molecular structure.*

* 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.