Leflunomide
Product Images NDC 54868-2319

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Leflunomide (NDC 54868-2319). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Physicians Total Care, 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

Leflunomide 10 mg Label (10mg Package Label)

Label for Leflunomide 10 mg showing distribution by Physicians Total Care, Inc. Includes lot number, expiration date, manufacturer information (Sandoz Inc., Princeton, NJ), and a barcode with numeric code.*

FDA Label Image

Leflunomide 20 mg Label (20mg Package Label)

Label for Leflunomide 20 mg distributed by Physicians Total Care, Inc., Tulsa, OK. The label includes the drug name, strength (20 mg), an expiration date (01/60), manufacturing details by Sandoz Inc. in Princeton NJ, and a barcode with corresponding numeric code.*

FDA Label Image

Leflunomide Chemical Structure (82b2a630 17c9 45b1 A468 233f76243fe4 01)

Chemical structure depicting the molecular formula of leflunomide, showing its characteristic rings and trifluoromethyl group.*

FDA Label Image

Chemical Structure Active Metabolite A77 1726 (m1) (82b2a630 17c9 45b1 A468 233f76243fe4 02)

Chemical structure of Leflunomide (A77 1726), showing the molecular arrangement including trifluoromethyl group, amide linkage, and nitrile functional group.*

FDA Label Image

Graph % Acr 20 Responder At Endpoint (82b2a630 17c9 45b1 A468 233f76243fe4 03)

A bar chart titled '% ACR 20 Responder at Endpoint' displaying the percentage response rates at the endpoint in three trials (US301, MN301, MN302). The chart compares Leflunomide (L), Methotrexate (M), Placebo (P), and Sulfasalazine (S) treatments over 6 to 12 months, showing that Leflunomide generally has higher response rates than placebo and comparable or slightly lower rates than Methotrexate or Sulfasalazine depending on the trial.*

FDA Label Image

Graph Us301 Acr Responders Over Time (82b2a630 17c9 45b1 A468 233f76243fe4 04)

A line graph titled 'US301 ACR Responders Over Time' showing the percentage of responders on the Y-axis and months on the X-axis from 0 to 12 months. It compares response rates over time for three groups: placebo (PL), methotrexate (MTX), and leflunomide (LEF), with leflunomide and methotrexate showing higher and sustained response rates compared to placebo.*

FDA Label Image

Graph Change In Sharp Score (82b2a630 17c9 45b1 A468 233f76243fe4 05)

A bar chart titled 'Change in Sharp Score' comparing progression scores across three clinical trials (US301, MN301, MN302) over different time frames. The chart shows bars for Leflunomide, Methotrexate, Sulfasalazine, and Placebo with numerical values indicating progression changes, where lower scores indicate reduced disease progression.*

FDA Label Image

Graph Change In Functional Measure (82b2a630 17c9 45b1 A468 233f76243fe4 06)

A bar chart titled 'Change in Functional Ability Measure' showing improvement scores over 6 and 12 months across three clinical trials (US301, MN301, MN302). The measure is based on the HAQ Disability Index, comparing Leflunomide (L) with Methotrexate (M), Sulfasalazine (S), and Placebo (P). Bars depict the relative improvement for each treatment group in each trial.*

* 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.