Leflunomide
Product Images NDC 68258-2992

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Leflunomide (NDC 68258-2992). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Dispensing Solutions, 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

64c92eb9-figure-01 (64c92eb9 Figure 01)

Chemical structure of Leflunomide, showing its molecular arrangement including a trifluoromethyl-substituted phenyl ring attached to an oxazole ring with an amide group.*

FDA Label Image

64c92eb9-figure-02 (64c92eb9 Figure 02)

Chemical structure diagram of Leflunomide showing its molecular arrangement with labeled functional groups including trifluoromethyl, amide, alkyne, hydroxyl, and nitrile groups.*

FDA Label Image

64c92eb9-figure-03 (64c92eb9 Figure 03)

A bar chart depicting the percentage of ACR 20 responders at endpoint for three clinical trials comparing Leflunomide (L), Methotrexate (M), Placebo (P), and Sulfasalazine (S) over 6 to 12 months. The chart shows response rates across trials US301, MN301, and MN302, with Leflunomide and Methotrexate generally showing higher response percentages than Placebo and Sulfasalazine.*

FDA Label Image

64c92eb9-figure-04. (64c92eb9 Figure 04)

A line graph titled "US301 ACR Responders Over Time" showing percentage of responders on the vertical axis and months on the horizontal axis over a 12-month period. The graph compares response rates among three groups: PL (placebo), MTX (methotrexate), and LEF (leflunomide), with LEF marked by triangles showing a higher response rate than the other two over time. The chart includes a note indicating the last observation was carried forward.*

FDA Label Image

64c92eb9-figure-05 (64c92eb9 Figure 05)

A bar chart titled 'Change in Sharp Score' showing progression over three clinical trials (US301 and MN302 at 12 months, MN301 at 6 months). The x-axis labels treatments: Leflunomide (L), Methotrexate (M), Sulfasalazine (S), and Placebo (P). The y-axis measures change in Sharp Score from progression to improvement. Bars indicate relative scores for each treatment in each trial, with numerical values above some bars for comparison.*

FDA Label Image

64c92eb9-figure-06 (64c92eb9 Figure 06)

A bar chart titled "Change in Functional Ability Measure" showing results from three clinical trials (US301, MN301, MN302) over different durations (6 or 12 months). The vertical axis represents improvement, with bars indicating the change for Leflunomide (L), Methotrexate (M), Placebo (P), and Sulfasalazine (S) as measured by the HAQ Disability Index.*

FDA Label Image

Ndc 68258-2992-03 (Ndc 68258 2992 03 Heritage)

DispenseQuick label for Leflunomide 20 mg tablets, package of 30, NDC 68258-2992-03, product number 2L0230. The label includes dosage instructions, warnings about pregnancy and serious liver injury, and identifies Dispensing Solutions, Inc. as the exclusive packager. It features a barcode and lot/sample information with an expiration date listed as 00-00.*

* 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.