Leflunomide Tablet, Film Coated
Product Images NDC 70748-129

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Leflunomide (NDC 70748-129). 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 connectivity including a trifluoromethyl-substituted phenyl group, an amide linkage, and a substituted oxazole ring.*

FDA Label Image

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Chemical structure of teriflunomide (A77 1726), the active metabolite of leflunomide, showing atoms and bonds including a trifluoromethyl-substituted phenyl ring connected to an amide and enolic group with a nitrile substituent.*

FDA Label Image

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A bar chart titled '% ACR 20 Responder at Endpoint' showing response rates from three clinical trials at 6 and 12 months. It compares percentages of patients responding to Leflunomide, Methotrexate, Placebo, and Sulfasalazine. Percentages range from about 18.6% to 56.6%, with Leflunomide generally showing higher response rates than Placebo in Trials 1 and 2.*

FDA Label Image

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A line graph titled 'Trial 1 ACR Responders Over Time' showing the percentage of responders over a 12-month period for three groups: placebo (PL), methotrexate (MTX), and leflunomide (LEF). The y-axis represents percent responders from -10 to 70, and the x-axis represents months from 0 to 12. Leflunomide shows the highest response rate over time compared to methotrexate and placebo.*

FDA Label Image

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A bar chart titled 'Change in Sharp Score' illustrating disease progression or improvement across three clinical trials with different treatment groups. The x-axis shows groups treated with Leflunomide, methotrexate, sulfasalazine, or placebo, while the y-axis represents Sharp Score change from -10 to +8. The chart compares scores at various time points: 12 months for Trial 1, 6 months for Trial 2, and 12 months for Trial 3, highlighting differences in progression among the treatments.*

FDA Label Image

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A bar chart showing Change in Functional Ability Measure over three clinical trials, with improvements measured by the HAQ Disability Index. The chart compares Leflunomide (L), Methotrexate (M), Placebo (P), and Sulfasalazine (S) across different trial durations: Trial 1 (12 months), Trial 2 (6 months), and Trial 3 (12 months). Values indicate varying degrees of functional improvement.*

FDA Label Image

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FDA Label Image

Figure 1 (D31d60f8 29ad 478b 85b2 Aabc27187368 08)

Label for Leflunomide Tablets USP 10 mg, film-coated oral tablets. The label indicates the product is prescription only and contains 30 tablets in an oversized container for ease of patient use. It is manufactured for Lupin Pharmaceuticals, Inc. and made by Lupin Limited in India. The label includes storage instructions and warnings.*

FDA Label Image

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Label for Leflunomide Tablets USP 20 mg film-coated tablets in a 30-tablet oversized container. The label includes storage instructions, dosage indication to see prescribing information, and warning to keep out of reach of children. Manufactured by Lupin Pharmaceuticals, Inc., Naples, FL, and Lupin Limited, India. Features barcodes and the NDC 70748-130-06.*

* 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.