Leflunomide Tablet, Film Coated
Product Images NDC 68071-3763

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Leflunomide (NDC 68071-3763). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nucare 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

Pdp (68071 3763 9)

Leflunomide 10 mg tablets packaging label from NuCare Pharmaceuticals, Inc. The label shows 90 count of film-coated tablets, each containing 10 mg of Leflunomide. Tablets are described as round white to off-white, debossed with 'L' on one side and 'AA' on the other. Includes NDC 68071-3763, product number P2267090, and storage instructions to keep at controlled temperature 68-77°F.*

FDA Label Image

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Chemical structure diagram showing the molecular structure of the active ingredient Leflunomide. The diagram includes rings and functional groups representative of Leflunomide's chemical composition.*

FDA Label Image

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Chemical structure of teriflunomide, the active metabolite of leflunomide, showing its molecular arrangement with labeled functional groups.*

FDA Label Image

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A bar graph titled '% ACR 20 Responder at Endpoint' presenting data from three clinical trials at 6 and 12 months. It compares percentage responses for Leflunomide (L), Methotrexate (M), Placebo (P), and Sulfasalazine (S) across trials. Percentages range from approximately 18.6% to 56.6%. The chart illustrates comparative efficacy of these treatments.*

FDA Label Image

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A line graph titled 'Trial 1 ACR Responders Over Time' depicting the percentage of responders over 12 months. The x-axis represents time in months (0, 3, 6, 9, 12), and the y-axis shows the percentage of responders ranging from -10 to 70%. The graph includes three lines comparing PL, MTX, and LEF treatments, with LEF reaching about 50% responders by month 3 and maintaining slightly above 50% through month 12.*

FDA Label Image

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A bar chart titled 'Change in Sharp Score' showing progression changes over three trials. The vertical axis represents progression scores from -10 to 8. Each trial compares different treatments: Trial 1 (12 months) with Leflunomide (L), methotrexate (M), and placebo (P); Trial 2 (6 months) with Leflunomide (L), sulfasalazine (S), and placebo (P); Trial 3 (12 months) with Leflunomide (L) and methotrexate (M). Each bar is labeled with numerical values representing score changes for each treatment group.*

FDA Label Image

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Bar chart titled 'Change in Functional Ability Measure' comparing improvement as measured by HAQ Disability Index across three trials of Leflunomide (L), Methotrexate (M), Placebo (P), and Sulfasalazine (S) over 6 to 12 months. The vertical axis represents the degree of improvement, with negative values indicating improvement.*

FDA Label Image

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* 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.