Tofacitinib Tablet, Film Coated, Extended Release
Product Images NDC 76282-816

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 76282-816). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Exelan 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

Fig 1. (Fig 1)

A scatter plot chart showing the pharmacokinetic (PK) ratios and 90% confidence intervals (CI) for Tofacitinib based on various intrinsic factors, including weight, age, sex, race, and degrees of renal and hepatic impairment. The chart compares AUC and Cmax values relative to reference, illustrating variability in drug exposure among these subgroups.*

FDA Label Image

Fig 2. (Fig 2)

A forest plot chart showing pharmacokinetic (PK) data for various coadministered drugs including Methotrexate, Midazolam, Levonorgestrel, Ethinyl Estradiol, and Metformin. The chart displays ratios and 90% confidence intervals for AUC and Cmax values relative to a reference, with values plotted along a horizontal axis ranging from 0 to 2.*

FDA Label Image

Fig 3. (Fig 3)

A pharmacokinetic (PK) ratio and 90% confidence interval (CI) chart comparing the AUC and Cmax values of various coadministered drugs relative to a reference. Drugs listed include Ketoconazole, Fluconazole, Rifampin, Methotrexate, Tacrolimus, and Cyclosporine. The chart visualizes the ratio of PK parameters with error bars showing the 90% CI, plotted along a horizontal axis indicating ratio relative to reference from 0 to 2.5.*

FDA Label Image

Fig 4. (Fig 4)

A line graph depicting response rates over a 6-month period comparing XELJANZ 5 mg Twice Daily to placebo. The x-axis represents months (0, 1, 3, 6), and the y-axis shows response rates with standard error. Two lines track response rates: one for XELJANZ (black circles) showing higher response rates, and one for placebo (open circles) showing lower response rates.*

FDA Label Image

Fig 5. (Fig 5)

A line chart comparing response rates over three months between Tofacitinib 5 mg BID and placebo. The x-axis shows time in months (visits), and the y-axis represents the response rate percentage with standard error bars. Two lines display results: a solid line for Tofacitinib 5 mg BID and a dashed line for placebo, showing higher response rates for Tofacitinib over time.*

FDA Label Image

Fig 6. (Fig 6)

A line chart displaying response rates (%) over weeks in a clinical study. The x-axis represents time in weeks, while the y-axis shows the response rate with standard error. Two treatments are compared: XELJANZ 5 mg twice daily (solid line with filled circles) and placebo (dashed line with open circles). Response rates increase over time, with XELJANZ showing higher rates than placebo throughout the 16-week period.*

FDA Label Image

Label. (Label)

Label for Tofacitinib Extended-Release Tablets, 11 mg strength, with a package count of 30 tablets. The label includes the NDC number 76282-816-30 and states the product is Rx only. It notes that each tablet contains 17.77 mg of tofacitinib citrate (equivalent to 11 mg tofacitinib). Manufactured by Orient Pharma Co., Ltd. in Taiwan and distributed by Exelan Pharmaceuticals, Inc. in Boca Raton, FL. Storage instructions specify 20°C to 25°C, and the label features the Exelan Pharmaceuticals logo and a barcode on the right.*

FDA Label Image

Structure. (Structure)

Chemical structure diagram of Tofacitinib, showing its molecular components and detailed bonding arrangement alongside the structure of an associated 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.