Leflunomide Tablet, Film Coated
Product Images NDC 71335-2256

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Leflunomide (NDC 71335-2256). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bryant Ranch Prepack, 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

Label (Lbl713352256)

The label for Leflunomide Tablets, USP contains 20 mg film-coated tablets. It includes storage instructions (20° to 25°C, protect from light) and a warning to keep drugs out of reach of children. The label shows NDC 71335-2256-1, indicates 30 tablets per container, and lists Bryant Ranch Prepack as the repackager and Aurobindo Pharma Limited as the manufacturer.*

FDA Label Image

Figure1 (Leflunomide Fig1)

A bar chart titled '% ACR 20 Responder at Endpoint' comparing percentage responses for three clinical trials of Leflunomide and other drugs. Trial 1 (12 months) compares Leflunomide, Methotrexate, and Placebo; Trial 2 (6 months) compares Leflunomide, Sulfasalazine, and Placebo; Trial 3 (12 months) compares Leflunomide and Methotrexate. Percentages range from about 18.6% to 56.6%. Data is shown in grouped bars for each drug, with a legend indicating abbreviations L, M, P, and S for each drug.*

FDA Label Image

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. It compares three groups labeled PL, MTX, and LEF over 12 months, with LEF showing the highest response percentage over time.*

FDA Label Image

Figure3 (Leflunomide Fig3)

Bar chart titled 'Change in Sharp Score' depicting progression changes over three clinical trials (two lasting 12 months, one 6 months). The chart compares Leflunomide (L), methotrexate (M), sulfasalazine (S), and placebo (P) across trials, showing numeric progression values below bars with Leflunomide generally showing lower progression versus placebo in each trial.*

FDA Label Image

Figure4 (Leflunomide Fig4)

A bar chart titled 'Change in Functional Ability Measure' showing results from three clinical trials measuring functional improvement using the HAQ Disability Index. It compares treatment groups with Leflunomide (L), Methotrexate (M), Placebo (P), and Sulfasalazine (S) over varying durations (6 to 12 months). Bars depict numerical changes indicating levels of improvement or decline.*

FDA Label Image

Structure (Leflunomide Str1)

Chemical structure of Leflunomide, displaying the molecular arrangement with a trifluoromethyl-substituted phenyl ring and an isoxazole moiety.*

FDA Label Image

Structure2 (Leflunomide Str2)

Chemical structure diagram of teriflunomide (A77 1726), an active metabolite of leflunomide. The structure includes fluorine-substituted aromatic rings and nitrile functional groups as depicted.*

* 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.