Leflunomide Tablet, Film Coated
Product Images NDC 59651-348

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Leflunomide (NDC 59651-348). 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.

FDA Label Image

Figure1 (Leflunomide Fig1)

A bar graph titled '% ACR 20 Responder at Endpoint' comparing response percentages in three clinical trials at 6 and 12 months. It shows response rates for Leflunomide (L), Methotrexate (M), Placebo (P), and Sulfasalazine (S) in the trials, with Leflunomide generally having higher response rates than Placebo, and values varying across trials.*

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Figure2 (Leflunomide Fig2)

A line graph titled 'Trial 1 ACR Responders Over Time' showing the percentage of responders on the y-axis and months on the x-axis from 0 to 12. The graph compares three groups: PL (placebo), MTX (methotrexate), and LEF (leflunomide), represented by different symbols and line styles. LEF shows the highest responder percentage increasing sharply initially and maintaining around 50-55%, MTX is slightly lower and stable around 45-50%, and PL remains around 20-30% over time.*

FDA Label Image

Figure3 (Leflunomide Fig3)

Bar chart titled 'Change in Sharp Score' comparing progression values for Leflunomide, methotrexate, sulfasalazine, and placebo across three clinical trials of 6 to 12 months. The x-axis lists treatment groups, and the y-axis denotes progression score changes from -10 to 10.*

FDA Label Image

Figure4 (Leflunomide Fig4)

A bar chart depicting change in functional ability measured by the HAQ Disability Index across three clinical trials at 6- and 12-month intervals. The chart compares Leflunomide (L), Methotrexate (M), Placebo (P), and Sulfasalazine (S) treatments, showing improvement values on the vertical axis with negative values indicating greater improvement.*

FDA Label Image

Package Label-principal Display Panel (10 mg (30 Tablets Bottle Label))

Leflunomide Tablets, USP 10 mg film-coated tablets packaging label. The label indicates 30 tablets per bottle, distributed by Aurobindo Pharma USA, Inc. It includes storage instructions, a warning to keep out of reach of children, and mentions the product is made in India. The label also displays the NDC 59651-348-30 and specifies dosage and administration information is in the package insert.*

FDA Label Image

Package Label-principal Display Panel (20 mg (30 Tablets Bottle Label))

Leflunomide Tablets USP 20 mg film-coated tablets packaging label. The label shows a 30-tablet count and states the product is for prescription use only. It includes storage instructions, distributor information for Aurobindo Pharma USA, Inc., and indicates the tablets contain 20 mg of leflunomide. The label is designed with the Aurobindo logo and a barcode on the right.*

FDA Label Image

Structure (Leflunomide Str1)

Chemical structure of Leflunomide, showing its molecular arrangement with a pyrimidine ring connected to a trifluoromethyl-substituted benzene ring.*

FDA Label Image

Structure2 (Leflunomide Str2)

Chemical structure of teriflunomide (A77 1726), the active metabolite related to Leflunomide. The diagram shows the molecular arrangement of atoms including trifluoromethyl-substituted phenyl ring and nitrile-containing side chain.*

* 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.