Pirfenidone Tablet, Film Coated
Product Images NDC 42385-925

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Pirfenidone (NDC 42385-925). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Laurus Labs Limited, 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

Pirfenidone Figure 1 (Pirfenidone Figure1)

A cumulative distribution plot depicting the percentage of patients versus absolute change in % predicted forced vital capacity (FVC) from baseline to week 52. The graph compares two groups, Pirfenidone (n=278) and Placebo (n=277), with the x-axis displaying change in %FVC and a division between worsening (decrease) and no decline (increase). The y-axis shows the percentage of patients, with annotations at 32% versus 17% and 90% versus 77% for Placebo and Pirfenidone, respectively.*

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Package Label.principal Display Panel (801 mg)

Pirfenidone 801 mg film coated tablets label showing 90 tablets per package. The label states the active ingredient strength, storage conditions (20° to 25°C), and directions to refer to the package insert for dosage. It is manufactured by Laurus Labs Limited and distributed by Laurus Generics Inc. The label includes an NDC barcode and a notice to keep out of reach of children.*

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Figure 11 (Pirfenidone Figure11)

A dosing schedule table for Pirfenidone capsules and tablets at 267 mg strength. It shows the number of pills taken in the morning, afternoon, and evening across three time periods: Days 1 to 7, Days 8 to 14, and Day 15 onward, with total daily pills increasing from 3 to 9.*

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Figure 12 (Pirfenidone Figure12)

A dosing schedule table for Pirfenidone Tablets 534 mg, detailing the administration of one tablet three times daily during days 8 to 14. The table specifies taking one tablet in the morning (breakfast), one in the afternoon (lunch), and one in the evening (dinner), totaling three pills each day.*

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Figure 13 (Pirfenidone Figure13)

A dosing schedule table for Pirfenidone tablets 801 mg, indicating to take one brown 801 mg pirfenidone tablet three times each day after Day 15. The table outlines the pill count for morning (breakfast), afternoon (lunch), and evening (dinner), with one tablet each time, totaling three pills per day.*

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Pirfenidone Figure 2 (Pirfenidone Figure2)

Line graph showing mean change in Forced Vital Capacity (FVC) in milliliters over 52 weeks comparing Pirfenidone versus Placebo. The graph depicts a slower decline in FVC for the Pirfenidone group (solid line) relative to the Placebo group (dashed line), with both groups starting at zero change at week 0 and diverging progressively over time.*

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Pirfenidone Figure 3 (Pirfenidone Figure3)

A Kaplan-Meier survival curve showing the percentage of patients alive over time in weeks for Pirfenidone and placebo groups. The graph compares survival between 623 Pirfenidone patients and 624 placebo patients up to 120 weeks, with a hazard ratio (HR) of 0.75 (95% CI: 0.51–1.11). Below the graph is a table listing the number of patients at risk at various time points for both groups.*

FDA Label Image

Package Label.principal Display Panel (267 mg)

Pirfenidone Capsules 267 mg label for oral use, showing package of 270 capsules. Manufactured by Laurus Labs Limited and labeled for Laurus Generics Inc. Storage instructions from 20° to 25°C, with dosage reference to package insert. Includes barcode, lot, and expiration placeholders.*

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Package Label.principal Display Panel (14-Day Titration Pack)

Packaging label for Pirfenidone Capsules 267 mg by Laurus Labs Limited. The label indicates a 14 day titration pack with Week 1 containing 21 capsules and Week 2 containing 42 capsules. Instructions include dosing guidelines for the two weeks. The label also includes storage instructions, manufacturer details, and a barcode.*

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Package Label.principal Display Panel (Maintenance Pack)

Outer carton label for Pirfenidone Capsules 267 mg by Laurus Labs Limited. The package contains 4 weekly packs totaling 252 capsules, with 63 capsules per weekly pack. The label includes storage instructions and manufacturer information for Laurus Generics Inc. and Laurus Labs Limited. NDC 42385-923-54 is displayed.*

FDA Label Image

Package Label.principal Display Panel (267 mg)

Label for Pirfenidone Tablets 267 mg film-coated tablets. The label states each tablet contains 267 mg of pirfenidone and provides storage instructions. It indicates a package size of 90 tablets, manufactured by Laurus Labs Limited and labeled for Laurus Generics Inc. The label includes dosage directions, lot, and expiration date fields, along with a barcode.*

FDA Label Image

Package Label.principal Display Panel (267 mg)

Pirfenidone Tablets 267 mg film-coated oral tablets packaging label. The label shows 270 tablets total, packaged as 3 bottles of 90 tablets each. Labeler is Laurus Labs Limited. The label includes storage information and the NDC 42385-924-99, stating the product is prescription only and to keep out of reach of children.*

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Package Label.principal Display Panel (534 mg)

Label for Pirfenidone Tablets 534 mg film-coated oral tablets by Laurus Labs Limited. The label shows the strength as 534 mg, quantity of 90 tablets, and includes storage instructions (20° to 25°C, allowances between 15° to 30°C) and dosage guidance to see package insert. Manufacturer and labeler addresses are also present along with a barcode and lot/expiration fields.*

FDA Label Image

Pirfenidone Chemical Structure (Pirfenidone Structure)

Chemical structure of Pirfenidone, showing a pyridone ring with a methyl substituent and a phenyl 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.