Tofacitinib Citrate Tablet, Film Coated, Extended Release
Product Images NDC 84677-081

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tofacitinib Citrate (NDC 84677-081). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Golden State Medical Supply, 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

Str (Tofacitinib Str)

Chemical structure diagram of tofacitinib citrate, showing the molecular arrangement of the active ingredient tofacitinib and the citrate moiety.*

FDA Label Image

Figure 1 (Tofacitinib Fig1)

A pharmacokinetic (PK) chart showing the ratio and 90% confidence intervals (CI) of AUC and Cmax relative to reference values for intrinsic factors such as weight (40 kg and 140 kg), age (80 years), sex (female), race (Asian, Black, Hispanic), and varying degrees of renal and hepatic impairment (mild, moderate, severe). The horizontal axis represents the ratio relative to reference from 0 to 4.*

FDA Label Image

Figure 2 (Tofacitinib Fig2)

A pharmacokinetic impact chart showing the effect of Tofacitinib on the pharmacokinetics (AUC and Cmax) of coadministered drugs including Methotrexate, Midazolam, Levonorgestrel, Ethinyl Estradiol, and Metformin. The chart displays ratios relative to reference with 90% confidence intervals, illustrating changes in drug exposure with Tofacitinib coadministration.*

FDA Label Image

Figure 3 (Tofacitinib Fig3)

A pharmacokinetic chart showing the ratio and 90% confidence intervals of area under the curve (AUC) and maximum concentration (Cmax) of Tofacitinib citrate when coadministered with various drugs including CYP3A inhibitors (Ketoconazole), CYP3A & CYP2C19 inhibitors (Fluconazole), CYP inducer (Rifampin), Methotrexate, Tacrolimus, and Cyclosporine. The x-axis represents the ratio relative to reference.*

FDA Label Image

Figure (Tofacitinib Fig4)

A line graph showing response rates with standard error over 6 months comparing XELJANZ 5 mg twice daily and placebo. The x-axis represents months (0, 1, 3, 6), and the y-axis shows response rates. Filled circles indicate XELJANZ, and open circles indicate placebo, with XELJANZ showing higher response rates throughout the period.*

FDA Label Image

Figure (Tofacitinib Fig5)

A line chart showing response rates over several months of visits for Tofacitinib 5 mg BID compared to placebo. The x-axis represents visit time in months from 0 to 3, and the y-axis shows response rate in percentage. The chart includes error bars indicating standard error of the mean for each data point.*

FDA Label Image

Figure 6 (Tofacitinib Fig6)

A line chart showing response rate percentage over 16 weeks comparing two treatments: XELJANZ 5 mg twice daily (solid line) and placebo (dashed line). The chart includes error bars representing standard error at each time point.*

FDA Label Image

84677-081-30lb Rev. 0926.jpg (84677 081 30lb Rev. 0926)

Label for Tofacitinib Extended-Release Tablets 11 mg by Golden State Medical Supply, Inc. The label includes the NDC 84677-081-30 and indicates a 30-tablet prescription package. It features usage instructions, storage conditions (20°C to 25°C), and child-resistant container requirements. The label also states that each tablet contains 11 mg of tofacitinib (equivalent to 17.77 mg tofacitinib citrate).*

* 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.