Tofacitinib Citrate Tablet, Film Coated, Extended Release
Product Images NDC 77771-567

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tofacitinib Citrate (NDC 77771-567). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Radha Pharmaceuticals, 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

Figure 1 (Tofacitinib Fig1)

A forest plot displaying pharmacokinetic parameter ratios (AUC and Cmax) with 90% confidence intervals relative to reference populations. The variables include intrinsic factors such as weight (40 kg, 140 kg), age (80 years), sex (female), race (Asian, Black, Hispanic), and degrees of renal and hepatic impairment (mild to severe). The horizontal axis shows ratio relative to reference values from 0 to 4.*

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Figure 2 (Tofacitinib Fig2)

A pharmacokinetic impact chart showing the effect of Tofacitinib on the pharmacokinetics of other drugs. The chart compares the AUC and Cmax ratios with 90% confidence intervals for methotrexate, midazolam (CYP3A substrate), levonorgestrel (oral contraceptive), ethinyl estradiol, and metformin (OCT & MATE substrate) relative to a reference.*

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Figure 3 (Tofacitinib Fig3)

A forest plot chart depicting the pharmacokinetic ratios and 90% confidence intervals for various coadministered drugs relative to a reference. The coadministered drugs include CYP3A inhibitors Ketoconazole and fluconazole, CYP inducer Rifampin, Methotrexate, Tacrolimus, and Cyclosporine, with plotted AUC and Cmax ratios showing their effect on the drug levels.*

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Figure (Tofacitinib Fig4)

A line graph showing response rates over 6 months comparing XELJANZ 5 mg twice daily (solid circles) with placebo (open circles). The vertical axis represents response rates with standard error, while the horizontal axis shows time in months. Response rates increase for both groups over time, with XELJANZ consistently higher than placebo.*

FDA Label Image

Figure (Tofacitinib Fig5)

A line graph showing the response rate (%) over a 3-month period comparing Tofacitinib 5 mg BID and placebo. The x-axis represents visit month intervals (0, 0.5, 1, 2, 3), and the y-axis shows response rate percentages. Two lines display increasing response rates over time, with Tofacitinib consistently higher than placebo. Error bars indicate standard error at each time point.*

FDA Label Image

Figure 6 (Tofacitinib Fig6)

A line graph showing response rate (± SE, %) over 16 weeks for two groups: XELJANZ 5 mg twice daily and Placebo. The x-axis is labeled 'Week' and the y-axis indicates response rate. The graph shows increasing response rates up to week 12, with XELJANZ consistently higher than Placebo.*

FDA Label Image

Package Label-principal Display Panel (11 mg)

Label for Tofacitinib Extended-Release Tablets, 11 mg, film-coated, oral dosage form. The label indicates a package of 30 tablets for prescription use only. Manufactured by ScieGen Pharmaceuticals and distributed by Radha Pharmaceuticals, Inc. Includes storage instructions and a barcode.*

FDA Label Image

Str (Tofacitinib Str)

Chemical structure of Tofacitinib citrate, showing the molecular components and arrangement of atoms in the compound.*

* 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.