Leflunomide Tablet, Film Coated
Product Images NDC 63629-9728

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Leflunomide (NDC 63629-9728). 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 (Lbl636299728)

Label for Leflunomide Tablets, USP 10 mg film-coated tablets, packaged in a quantity of 90 tablets. The label shows the NDC 63629-9728-1 and states it is repackaged by Bryant Ranch Prepack and manufactured by Aurobindo Pharma Limited. Storage instructions and warnings are also included.*

FDA Label Image

Figure1 (Leflunomide Fig1)

A bar chart titled '% ACR 20 Responder at Endpoint' comparing three clinical trials measuring response percentages for Leflunomide (L), Methotrexate (M), Placebo (P), and Sulfasalazine (S). The chart shows data from Trial 1 (12 months), Trial 2 (6 months), and Trial 3 (12 months) with percentage response values labeled for each treatment group.*

FDA Label Image

Figure2 (Leflunomide Fig2)

Line graph titled 'Trial 1 ACR Responders Over Time' showing the percentage of responders over 12 months for three groups: PL, MTX, and LEF. The x-axis represents time in months from 0 to 12, and the y-axis represents the percentage of responders from -10% to 70%. The graph includes a legend distinguishing the three groups by different line styles and markers. A note at the bottom states 'Last Observation Carried Forward.'*

FDA Label Image

Figure3 (Leflunomide Fig3)

A bar chart titled 'Change in Sharp Score' illustrating disease progression comparison across three clinical trials of varying durations (6 and 12 months). The chart compares the effects of Leflunomide (L), methotrexate (M), sulfasalazine (S), and placebo (P) with numerical values displayed above each bar. Progression values are plotted on the vertical axis with negative values indicating improvement.*

FDA Label Image

Figure4 (Leflunomide Fig4)

A bar chart titled 'Change in Functional Ability Measure' showing results from three clinical trials at 6 or 12 months. The y-axis measures improvement, with bars representing different treatments: Leflunomide (L), Methotrexate (M), Placebo (P), and Sulfasalazine (S). Negative values indicate improvement as measured by the HAQ Disability Index for each treatment group in each trial.*

FDA Label Image

Structure (Leflunomide Str1)

Chemical structure of Leflunomide, showing its distinctive molecular arrangement including a trifluoromethyl-substituted phenyl ring and an isoxazole ring with methyl and amide groups.*

FDA Label Image

Structure2 (Leflunomide Str2)

Chemical structure of teriflunomide (A77 1726), the active metabolite of Leflunomide, showing molecular groups including trifluoromethyl and cyano functionalities.*

* 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.