Tofacitinib Tablet, Extended Release
Product Images NDC 27241-270

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 27241-270). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ajanta Pharma Usa 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

11mg (Tofacitinib 11mg)

Label for Tofacitinib Extended-Release Tablets 11 mg, containing 30 tablets per package. Manufactured by Ajanta Pharma Limited, India, and marketed by Ajanta Pharma USA Inc. The label includes storage instructions, dosage form, NDC 27241-270-30, and a note to dispense the Medication Guide to each patient.*

FDA Label Image

Figure4 (Tofacitinib Fig4)

A line graph depicting the response rates over time (up to 6 months) comparing Tofacitinib 5 mg twice daily and placebo. The y-axis shows response rates with standard error, while the x-axis represents months. Two lines track response changes for each group.*

FDA Label Image

Figure1 (Tofacitinib Figure1)

A forest plot chart showing pharmacokinetic parameters, including AUC and Cmax ratios relative to reference, across different demographics and conditions such as weight, age, sex, ethnicity, and levels of renal and hepatic impairment. The chart includes confidence intervals and dose adjustment recommendations.*

FDA Label Image

Figure2 (Tofacitinib Figure2)

A dot plot chart showing the pharmacokinetic ratio and 90% confidence intervals of Tofacitinib when coadministered with various drugs including Methotrexate, Midazolam (CYP3A substrate), oral contraceptives (Levonorgestrel and Ethinyl Estradiol), and Metformin (OCT & MATE substrate). The chart indicates no dose adjustment recommendations, with ratios relative to reference near 1 for AUC and Cmax parameters.*

FDA Label Image

Figure3 (Tofacitinib Figure3)

This figure is a plot showing the pharmacokinetic (PK) drug-drug interaction ratios and 90% confidence intervals of tofacitinib when coadministered with various drugs. The x-axis represents the ratio relative to a reference value (1.0), while the y-axis lists coadministered drugs including ketoconazole, fluconazole, rifampin, methotrexate, tacrolimus, and cyclosporine, with corresponding AUC and Cmax measures. The right side provides dosing recommendations such as dose adjustment or warnings about immunosuppression risks when taken with tacrolimus or cyclosporine.*

FDA Label Image

Figure5 (Tofacitinib Figure5)

A line chart comparing response rates over a three-month period between Tofacitinib 5 mg BID and placebo. The x-axis represents visit months (0, 0.5, 1, 2, 3) and the y-axis shows response rate percentage from 0 to 100%. The chart includes error bars indicating standard error for each data point.*

FDA Label Image

Figure6 (Tofacitinib Figure6)

A line graph comparing response rates (%) over a 16-week period between Tofacitinib 5 mg twice daily treatment and placebo. The x-axis represents weeks, and the y-axis shows response rate percentages. Tofacitinib demonstrates higher response rates than placebo throughout the study duration, with error bars indicating standard error.*

FDA Label Image

Structure (Tofacitinib Structure)

Chemical structure of Tofacitinib, showing its molecular composition with characteristic rings and functional groups.*

* 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.