Tofacitinib Tablet, Film Coated, Extended Release
Product Images NDC 60505-4858

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 60505-4858). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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

Btl11mg.jpg (Btl11mg)

Label for Tofacitinib Extended-Release Tablets 11 mg, film-coated, oral tablets, supplied in a package of 30 tablets. The label includes storage directions (20°C to 25°C), dispensing instructions, and manufacturer information for Apotex Inc., Toronto, Ontario, and Apotex Corp., Weston, Florida. The NDC is 60505-4858-3. The label prominently features the brand name with pink and blue color blocks and a barcode.*

FDA Label Image

Figure1.jpg (Figure1)

A ratio and 90% confidence interval chart displaying pharmacokinetic (PK) parameters AUC and Cmax of tofacitinib across intrinsic factors including weight (40 kg, 140 kg), age (80 years), sex (female), race (Asian, Black, Hispanic), and renal and hepatic impairment (mild, moderate, severe for renal; mild, moderate for hepatic). The x-axis shows the ratio relative to reference from 0 to 4.*

FDA Label Image

Figure2.jpg (Figure2)

A pharmacokinetic (PK) graph showing ratios and 90% confidence intervals for area under curve (AUC) and maximum concentration (Cmax) of several coadministered drugs relative to reference values. Drugs listed include Methotrexate, Midazolam (CYP3A substrate), Levonorgestrel and Ethinyl Estradiol (oral contraceptives), and Metformin (OCT & MATE substrate). The x-axis represents the ratio relative to reference from 0 to 2.*

FDA Label Image

Figure3.jpg (Figure3)

A pharmacokinetic ratio chart showing the effect of various coadministered drugs on the area under the curve (AUC) and maximum concentration (Cmax) of a reference drug. The x-axis represents the ratio relative to reference, with values ranging from 0 to 2.5, and the y-axis lists coadministered drugs including ketoconazole, fluconazole, rifampin, methotrexate, tacrolimus, and cyclosporine. Each drug has two plotted points representing AUC and Cmax with 90% confidence intervals.*

FDA Label Image

Figure4.jpg (Figure4)

A line graph depicting response rates over 0, 1, 3, and 6 months comparing XELJANZ 5 mg twice daily and placebo. The y-axis shows response rate percentages with standard error, and the x-axis shows months. Black circles represent XELJANZ and white circles represent placebo, with XELJANZ showing higher response rates throughout the study period.*

FDA Label Image

Figure5.jpg (Figure5)

A line graph depicting the response rate percentage over a 3-month period for Tofacitinib 5 mg BID compared to placebo. The x-axis shows visit months (0, 0.5, 1, 2, 3) and the y-axis shows response rate with standard error bars, illustrating higher response rates for Tofacitinib than placebo throughout the study period.*

FDA Label Image

Figure6.jpg (Figure6)

A line graph comparing response rates over 16 weeks between two treatments: XELJANZ 5 mg twice daily and placebo. The x-axis represents weeks from 0 to 16, and the y-axis shows response rates as percentages. Data points include error bars representing standard error. The XELJANZ group shows higher response rates throughout the study compared to placebo.*

FDA Label Image

Structure.jpg (Structure)

Chemical structure of tofacitinib, showing its molecular arrangement including a nitrile group and multiple nitrogen atoms in a fused ring system, accompanied by a citric acid molecule likely representing a salt form.*

* 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.