Leflunomide Tablet
Product Images NDC 60505-2502

8 FDA label images from Apotex Corp. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Leflunomide (NDC 60505-2502). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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

20mg-30btl.jpg (20mg 30btl)

20mg-30btl.jpg (20mg 30btl)
Label for Leflunomide Tablets, USP 20 mg oral tablets by Apotex Corp. The label indicates a package count of 30 tablets and includes storage instructions, manufacturer and labeler information, and the NDC number 60505-2503-1. The label highlights that the product is prescription only and shows a barcode for scanning.*
FDA Label Image

Figure1.jpg (Figure1)

Figure1.jpg (Figure1)
A bar graph showing the percentage of ACR 20 responders at endpoint across three clinical trials. The x-axis represents treatment types including Leflunomide (L), Methotrexate (M), Placebo (P), and Sulfasalazine (S). The y-axis shows percentages from -20 to 70. Each trial's duration is noted: Trial 1 (12 months), Trial 2 (6 months), Trial 3 (12 months). Bars compare response rates for these treatments in each trial.*
FDA Label Image

Figure2.jpg (Figure2)

Figure2.jpg (Figure2)
A line graph titled 'Trial 1 ACR Responders Over Time' showing the percentage of responders over a 12-month period. The x-axis is labeled 'Months' and the y-axis is labeled '% Responders' ranging from -10 to 70. Three treatment groups are represented: PL (placebo) with circles and solid line, MTX (methotrexate) with squares and dashed line, and LEF (leflunomide) with triangles and solid line. The graph shows that LEF has the highest response rate over time, followed by MTX and PL. A note at the bottom states 'Last Observation Carried Forward.'*
FDA Label Image

Figure3.jpg (Figure3)

Figure3.jpg (Figure3)
A bar chart titled 'Change in Sharp Score' showing progression or regression over three clinical trials of different durations (12 months, 6 months, 12 months). It compares the effects of Leflunomide (L), Methotrexate (M), Sulfasalazine (S), and Placebo (P) on Sharp Score changes, with bars depicting numerical values for each treatment.*
FDA Label Image

Figure4.jpg (Figure4)

Figure4.jpg (Figure4)
A bar chart titled 'Change in Functional Ability Measure' showing improvement measured by HAQ Disability Index across three trials. Each trial displays bars for different treatments labeled L (Leflunomide), M (Methotrexate or similar), P (Placebo), and S (Sulfasalazine in Trial 2). The y-axis quantifies improvement from 0 to -0.6. The chart compares the extent of functional ability changes over 6 to 12 months of treatment.*
FDA Label Image

Lbl10mg30s

Lbl10mg30s
Label for Leflunomide Tablets, USP 10 mg oral tablets by Apotex Corp. The label shows a 30-tablet count with NDC 60505-2502-1, storage instructions, and manufacturer information for Apotex Inc. in Toronto, Canada, and Apotex Corp. in Weston, Florida. The product is prescription only.*
FDA Label Image

Structure1.jpg (Structure1)

Structure1.jpg (Structure1)
Chemical structure of leflunomide, showing its molecular arrangement including a trifluoromethyl-substituted phenyl group connected to an amide and an oxazole ring with a methyl substituent.*
FDA Label Image

Structure2.jpg (Structure2)

Structure2.jpg (Structure2)
Chemical structure of leflunomide, showing the molecular arrangement with trifluoromethyl-substituted phenyl ring, amide linkage, and cyano and hydroxyl groups attached to a carbon chain.*

* 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.