Tofacitinib Tablet, Extended Release
Product Images NDC 72162-2684

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 72162-2684). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bryant Ranch Prepack, 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

Label (Lbl721622684)

Label for Tofacitinib Extended-Release Tablets 11 mg, oral dosage form, with 30 tablets per package. Relabeled by Bryant Ranch Prepack, Inc., Burbank, CA, and manufactured by Aurobindo Pharma Limited. Includes storage information, QR codes for package insert and medication guide, and barcodes with NDC 72162-2684-3.*

FDA Label Image

Figure 1 (Tofacitinib Fig1)

A forest plot chart illustrating pharmacokinetic (PK) factors affecting Tofacitinib, with ratios and 90% confidence intervals (CI) for AUC and Cmax parameters. The chart compares intrinsic factors such as weight (40 kg, 140 kg), age (80 years), sex (female), race (Asian, Black, Hispanic), and renal and hepatic impairment (mild, moderate, severe) relative to a reference value on the x-axis.*

FDA Label Image

Figure 2 (Tofacitinib Fig2)

A forest plot chart showing the pharmacokinetic (PK) ratios and 90% confidence intervals (CI) for various coadministered drugs compared to a reference. The chart displays area under the curve (AUC) and maximum concentration (Cmax) ratios for Methotrexate, Midazolam (a CYP3A substrate), Levonorgestrel and Ethinyl Estradiol (oral contraceptives), and Metformin (an OCT & MATE substrate). Ratios are plotted on a horizontal axis from 0 to 2 relative to reference values.*

FDA Label Image

Figure 3 (Tofacitinib Fig3)

A chart showing the pharmacokinetic interaction of various coadministered drugs with a reference drug. The horizontal axis represents the ratio relative to reference, ranging from 0 to 2.5. The chart lists six drugs (Ketoconazole, Fluconazole, Rifampin, Methotrexate, Tacrolimus, Cyclosporine) alongside their drug type classification (e.g., CYP3A Inhibitor) and pharmacokinetic measures (AUC and Cmax). Each drug's ratio and 90% confidence interval are plotted as dots with error bars, indicating changes in drug levels relative to the reference.*

FDA Label Image

Figure (Tofacitinib Fig4)

A line graph showing response rates over a 6-month period, comparing Tofacitinib 5 mg taken twice daily with a placebo. The y-axis represents response rates with standard error, and the x-axis shows time in months. Tofacitinib shows higher response rates than placebo throughout the period.*

FDA Label Image

Figure (Tofacitinib Fig5)

A line graph depicting response rates (%) over a 3-month period with visits marked at 0, 0.5, 1, 2, and 3 months. Two lines compare treatment with Tofacitinib 5 mg BID and placebo, showing higher response rates for Tofacitinib across the visits. Error bars indicate standard error values.*

FDA Label Image

Figure 6 (Tofacitinib Fig6)

A line graph depicting response rates over 16 weeks comparing Tofacitinib 5 mg twice daily and placebo. The y-axis represents response rate (± SE %) and the x-axis indicates weeks. Two lines show higher response rates for Tofacitinib than placebo throughout the study period with error bars.*

FDA Label Image

Str (Tofacitinib Str)

Chemical structure diagram showing the active ingredient tofacitinib combined with a compound represented by a molecule containing multiple carboxyl groups, likely indicating 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.