Leflunomide Tablet
Product Images NDC 10702-277

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Leflunomide (NDC 10702-277). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Kvk-tech, 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

Table1 (Table1)

A data table showing liver enzyme elevations greater than three-fold upper limits of normal in patients with rheumatoid arthritis across three clinical trials. It compares Leflunomide tablets 20 mg/day with methotrexate, placebo, and sulfasalazine, detailing ALT elevations, reversed elevations, and timing of enzyme elevation in months.*

FDA Label Image

Table2 (Table2)

Table showing the percentage of patients experiencing adverse events of 5% or more in rheumatoid arthritis (RA) studies across leflunomide tablets 20 mg/day and comparator groups including placebo, sulfasalazine, and methotrexate. It summarizes data from placebo-controlled and active-controlled trials, detailing adverse events like diarrhea, headache, nausea, rash, abnormal liver enzymes, and several others, comparing incidence rates among different treatment groups in all RA studies.*

FDA Label Image

Chemicalstructure (Chemicalstructuredescription)

Chemical structure diagram of Leflunomide, showing its molecular arrangement including aromatic rings, fluorine atoms, nitrogen, oxygen, and methyl groups consistent with the active ingredient Leflunomide.*

FDA Label Image

Chemicalstructure (Chemicalstructurepharmacoki)

Chemical structure of Leflunomide (teriflunomide), showing its molecular arrangement including a trifluoromethyl-substituted phenyl ring, amide group, and cyano group.*

FDA Label Image

Figure1 (Figure1)

A bar chart titled 'Percentage of ACR20 Responders at Endpoint in Patients with Active RA in Trials 1, 2, and 3' showing percentage response rates for Leflunomide, Methotrexate, Placebo, and Sulfasalazine across three clinical trials. The chart includes comparisons of response percentages, confidence intervals, and p-values for Leflunomide against other treatments and placebo at 6 and 12 months.*

FDA Label Image

Figure2 (Figure2)

A line graph titled 'Trial 1 ACR Responders Over Time' showing percentage of ACR20 responders over 12 months in patients with active rheumatoid arthritis. The x-axis represents time in months (0 to 12) and the y-axis represents percentage responders (from -10 to 70%). Three lines represent PL (placebo), MTX (methotrexate), and LEF (leflunomide), with LEF achieving the highest responder rates throughout the study period.*

FDA Label Image

Table3 (Table3)

A data table titled 'Summary of ACR Response Rates in Patients with Active RA in Trials 1, 2, and 3,' comparing ACR20, ACR50, and ACR70 response rates across placebo-controlled and non-placebo active-controlled trials for leflunomide tablets, placebo, methotrexate, and sulfasalazine. The table includes patient numbers (n) and statistical significance indicators.*

FDA Label Image

Table4 (Table4)

A data table titled 'Mean Change in the Components of the ACR Responder Index in Patients with Active RA in Trials 1, 2, and 3.' It compares the effects of Leflunomide, Methotrexate, Placebo, Sulfasalazine across multiple clinical trials with metrics such as tender joint count, swollen joint count, patient global assessment, physician global assessment, physical function/disability, pain intensity, erythrocyte sedimentation rate, and C-reactive protein. The table also includes morning stiffness duration not included in the ACR Responder Index, showing numerical changes for each treatment group over different trial durations.*

FDA Label Image

Figure3 (Figure3)

A bar chart titled "Change in Sharp Score" showing progression and improvement in patients with active rheumatoid arthritis across three clinical trials of Leflunomide, methotrexate, sulfasalazine, and placebo. The chart compares changes in scores at different trial durations, illustrating relative effectiveness. Accompanying tables present 95% confidence intervals and p values for each comparison.*

FDA Label Image

Figure4 (Figure4)

Bar graph showing the change in functional ability measure in patients with active rheumatoid arthritis (RA) across three clinical trials of Leflunomide versus Methotrexate, Placebo, and Sulfasalazine. The vertical axis represents improvement in HAQ Disability Index scores, with lower values indicating greater improvement. Data labels show numerical changes for each treatment group within the 12- or 6-month trials as well as corresponding 95% confidence intervals and p-values comparing Leflunomide tablets to other treatments.*

FDA Label Image

Howsupplied (Howsupplied)

A table listing Leflunomide oral tablets in two strengths: 10 mg and 20 mg. Both come in 30-count bottles. The 10 mg tablets are white, round, film-coated, biconvex, debossed "V55" on one side. The 20 mg tablets are yellow, triangular, film-coated, biconvex, debossed "V56" on one side. Both have a plain opposite side. NDC numbers are 10702-277-03 for 10 mg and 10702-278-03 for 20 mg tablets.*

FDA Label Image

Companylogo (Companylogo)

FDA Label Image

Containerlabel10mg (Containerlabel10mg)

Leflunomide Tablets, USP 10 mg oral tablets label by KVK-Tech, Inc. The package contains 30 tablets. The label includes dosage strength, NDC, storage instructions, tamper evidence information, and manufacturer details.*

FDA Label Image

Containerlabel20mg (Containerlabel20mg)

Label for Leflunomide Tablets, USP 20 mg from KVK-Tech, Inc. The label states the product contains 20 mg of Leflunomide per film-coated tablet and comes in a bottle of 30 tablets. It includes storage instructions, a warning to keep out of reach of children, and tamper-evident packaging details. The label shows the NDC 10702-278-03 and notes the product is for prescription use only.*

* 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.