Leflunomide Tablet
Product Images NDC 50268-478

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Leflunomide (NDC 50268-478). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avpak, 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

10 (477 15 10mg)

Label for Leflunomide Tablets, USP 10 mg oral tablets, Rx only, containing 50 tablets (5 x 10) per unit dose. The label shows the NDC 50268-477-15 and states each tablet contains 10 mg of leflunomide. Manufactured for AvKARE in Pulaski, TN, with storage instructions at 25°C (77°F) and light protection noted.*

FDA Label Image

20 (478 15 20mg)

Packaging label for Leflunomide Tablets, USP 20 mg oral tablets. The label shows the product name and strength, NDC 50268-478-15, with a quantity of 50 tablets per bottle (5 blister packs of 10 tablets each). It includes storage instructions, manufacturer information for AvKARE in Pulaski, TN, and a barcode.*

FDA Label Image

Figure1.jpg (Figure1)

A bar chart titled '% ACR 20 Responder at Endpoint' comparing percentage responses across three clinical trials at different durations (6 and 12 months). The chart shows response percentages for Leflunomide, Methotrexate, Placebo, and Sulfasalazine, with Leflunomide included in all trials. Each agent is represented by distinct patterned bars.*

FDA Label Image

Figure2.jpg (Figure2)

A line chart titled 'Trial 1 ACR Responders Over Time' showing the percentage of responders over 12 months 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 time in months from 0 to 12. The chart shows LEF having the highest response rate over time, followed by MTX and then PL.*

FDA Label Image

Figure3.jpg (Figure3)

A bar chart titled 'Change in Sharp Score' showing progression and regression over three trials with durations of 12 months, 6 months, and 12 months respectively. The chart compares Leflunomide (L), Methotrexate (M), Sulfasalazine (S), and Placebo (P) treatments, illustrating numerical scores for each treatment group across trials.*

FDA Label Image

Figure4.jpg (Figure4)

A bar chart titled 'Change in Functional Ability Measure' showing three clinical trials comparing Leflunomide (L), Methotrexate (M), and Placebo (P) or Sulfasalazine (S) over 6 to 12 months. The graph displays mean changes measured by the HAQ Disability Index, indicating degrees of improvement with negative values on the y-axis.*

FDA Label Image

Structure1.jpg (Structure1)

Chemical structure of leflunomide showing its molecular components, including a trifluoromethyl-substituted phenyl ring connected to an amide and an oxazole ring with a methyl group.*

FDA Label Image

Structure2.jpg (Structure2)

Chemical structure of leflunomide, showing the molecular arrangement including a trifluoromethyl-substituted aromatic ring connected to an amide and a cyanide group with additional hydroxyl and methyl substituents.*

* 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.