Leflunomide Tablet, Film Coated
Product Images NDC 70748-130

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Leflunomide (NDC 70748-130). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Lupin Pharmaceuticals, 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

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Chemical structure of Leflunomide, showing the molecular arrangement of the active ingredient including a trifluoromethyl-substituted phenyl group and an isoxazole ring.*

FDA Label Image

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Chemical structure of teriflunomide, identified as A77 1726, the active metabolite of leflunomide. The structure shows a trifluoromethyl-substituted aromatic ring linked to a cyano-substituted alpha,beta-unsaturated carboxylic acid with an amide group.*

FDA Label Image

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A bar chart titled '% ACR 20 Responder at Endpoint' showing response percentages across three clinical trials at 6 or 12 months. Bars represent Leflunomide, Methotrexate, Placebo, and Sulfasalazine for Trials 1, 2, and 3, with response rates ranging approximately from 18.6% to 56.6%. The chart compares effectiveness outcomes of these drugs over time.*

FDA Label Image

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A line graph titled 'Trial 1 ACR Responders Over Time' showing the percentage of responders over 12 months. The x-axis represents time in months (0 to 12), and the y-axis represents the percentage of responders (ranging from -10 to 70%). Three lines represent different treatments: PL (placebo), MTX, and LEF (leflunomide), with LEF showing the highest responder percentage throughout the time points.*

FDA Label Image

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A bar chart titled 'Change in Sharp Score' showing progression data across three clinical trials of different durations (6 and 12 months). The X-axis groups data by drug: Leflunomide (L), methotrexate (M), sulfasalazine (S), and placebo (P). The Y-axis measures Sharp score progression with values ranging approximately from -10 to 8. Bars indicate progression changes for each treatment under each trial.*

FDA Label Image

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A bar chart titled 'Change in Functional Ability Measure' showing improvement values as measured by the HAQ Disability Index across three clinical trials of 6 to 12 months. The treatments compared are Leflunomide, Methotrexate, Placebo, and Sulfasalazine, indicated by bars labeled L, M, P, and S respectively. The y-axis represents improvement, with negative values indicating greater improvement.*

FDA Label Image

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Lupin Pharmaceuticals, Inc. label for Leflunomide Tablets USP, 10 mg film-coated tablets, oral dosage form. The container holds 30 tablets. Label includes storage instructions, manufacturer information, and a barcode, indicating an oversized container for ease of patient use.*

FDA Label Image

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Leflunomide Tablets USP 10 mg film coated tablets carton label from Lupin Pharmaceuticals, Inc. The label states each tablet contains 10 mg Leflunomide, prescription only, with a package size of 30 tablets. Storage and warning information is included, noting an oversized container for patient ease of use. Manufactured by Lupin Limited in India, labeled for US distribution.*

FDA Label Image

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Leflunomide Tablets USP 20 mg film coated oral tablets in an oversized container for ease of patient use. The label indicates a package of 30 tablets, manufactured by Lupin Pharmaceuticals, Inc. The label includes storage instructions and a warning to keep out of reach of children.*

FDA Label Image

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Packaging label for Leflunomide Tablets USP, 20 mg film-coated oral tablets. The label includes dosage strength, quantity of 30 tablets, and indicates it is an oversized container for ease of patient use. The labeler is Lupin Pharmaceuticals, Inc. The label provides storage instructions, and warnings, and identifies manufacturing locations in the United States and India.*

* 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.