Pirfenidone Capsule
Product Images NDC 59651-244

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Pirfenidone (NDC 59651-244). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma 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.

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Figure1 (Pirfenidone Fig1)

This is a description related to the Cumulative Distribution of Patients by Change in Percent Predicted FVC from Baseline to Week 52 in a study (Study 1). The Figure shows the distribution with Dashed Lines indicating either a decline of more than 10% or no decline. It also illustrates worsening with a decrease in %FVC and improvement with an increase in %FVC. The data presents the distribution of patients based on the absolute change in %FVC from Baseline to Week 52.*

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Package Label.principal Display Panel (Maintenance Carton Pack)

This text contains information about Pirfenidone Capsules, USP distributed by Aurobindo Pharma USA, Inc. Each carton includes 4 Weekly Packs with 252 capsules in total, with each weekly pack containing 63 capsules of Pirfenidone USP at 267 mg each. The usual dosage and storage instructions are included, with mention of the non-child resistant nature of blister cards. The text also includes the address of the distributor and manufacturing information stating that the product is made in India.*

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Figure2 (Pirfenidone Fig2)

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Figure3 (Pirfenidone Fig3)

The text provides Kaplan-Meier estimates of all-cause mortality for Studies 1, 2, and 3. The data shows the comparison between Pirfenidone and Placebo treatments over time in terms of hazard ratios and confidence intervals. Pirfenidone had an HR of 0.75 (95% CI: 0.51 to 1.11) compared to Placebo. The graph represents the survival curves over weeks for the two treatments, with corresponding patient numbers at risk at various time points.*

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Table Figue 4 (Pirfenidone Fig4)

This text provides a dosing schedule for Pirfenidone Capsules 267 mg. The schedule outlines the number of pills to be taken in the morning, afternoon, and evening for each week. In the first week (Days 1 to 7), the dosage is 1 pill each during breakfast, lunch, and dinner, totaling 3 pills per day. In the second week (Days 8 to 14), the dosage is 2 pills each during breakfast, lunch, and dinner, totaling 6 pills per day. From the 15th day onwards, the dosage increases to 3 pills each during breakfast, lunch, and dinner, totaling 9 pills per day.*

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Package Label.principal Display Panel (267 mg (270 Capsules Container Label))

This is a description for Pirfenidone capsules, each containing 267 mg. It is distributed by Aurobindo Pharma USA, Inc. and manufactured in India. The capsules are available in a pack of 270 and the usual dosage information is provided. It is recommended to keep the medication out of reach of children and store it at 20° to 25°C (68° to 77°F).*

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Package Label.principal Display Panel (267 mg (270 Capsules Container Carton Label))

This text provides information on a medication called Pirfenidone Capsules, with each capsule containing 267 mg of Pirenidone USP. The product is distributed by Aurobindo Pharma USA, Inc. and is manufactured in India. The usual dosage and administration details are available in the package insert. The medication is stored at a temperature range of 20°C to 25°C. This is a prescription medicine and should be kept out of reach of children. The National Drug Code (NDC) for this product is 59651-244-27, and it is provided in a package of 270 capsules.*

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

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

This is a description of Pirfenidone Capsules, USP, in a 14-Day Titration Pack. It includes dosing instructions for the first 2 weeks of therapy, with week 1 dosing containing 21 capsules and week 2 dosing containing 42 capsules. Each capsule contains 267 mg of Pirfenidone USP. The medication is distributed by Aurobindo Pharma USA, Inc. The packaging also includes storage instructions and the manufacturer's contact information. It is important to keep this medication out of reach of children.*

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Package Label.principal Display Panel (Maintenance Wallet Pack)

This is a description of Pirfenidone Capsules USP, 267 mg, a medication used for a certain condition. It comes in a weekly pack containing 63 capsules with each capsule containing Pirfenidone USP. The usual dosage information can be found in the package insert for administration guidance. The medication is distributed by Aurobindo Pharma USA and should be stored at 20° to 25°C. This product is made in India and should be kept out of reach of children.*

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Structure (Pirfenidone Str)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.