Tofacitinib Tablet, Film Coated
Product Images NDC 70710-1243

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 70710-1243). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Zydus Pharmaceuticals 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

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Chemical structure diagram of tofacitinib, showing its molecular composition including nitrogen-containing rings and a connected citrate molecule.*

FDA Label Image

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A chart showing pharmacokinetic ratios and 90% confidence intervals for intrinsic factors affecting tofacitinib, including weight, age, gender, ethnicity, and degrees of renal and hepatic impairment. The horizontal axis represents the ratio relative to reference for AUC and Cmax values.*

FDA Label Image

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This figure is a ratio plot with 90% confidence intervals showing the pharmacokinetic parameters AUC and Cmax for various coadministered drugs relative to a reference. Drugs include Methotrexate, Midazolam (CYP3A substrate), oral contraceptives Levonorgestrel and Ethinyl Estradiol, and Metformin (OCT & MATE substrate). The ratios range from approximately 0.5 to 1.25 on the x-axis.*

FDA Label Image

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A dot plot chart illustrating the ratio and 90% confidence intervals of coadministered drugs' pharmacokinetic parameters (AUC and Cmax) relative to a reference. The drugs listed include ketoconazole, fluconazole, rifampin, methotrexate, tacrolimus, and cyclosporine, with ratios shown along the x-axis from 0 to 2.5.*

FDA Label Image

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A line graph comparing response rates over six months between tofacitinib 5 mg twice daily and placebo groups. Response rates with standard error are plotted, showing higher and increasing response for tofacitinib from month 1 to month 3, then slightly decreasing at month 6, while placebo response rates remain lower throughout the period.*

FDA Label Image

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A line graph comparing responder rates (percentage) over a 3-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 responder rate percentages from 0 to 100%. The graph includes error bars and two lines: a solid line for tofacitinib 5 mg BID that rises steadily, and a dashed line for placebo with a lower responder rate trend.*

FDA Label Image

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A line graph comparing response rates over 16 weeks between tofacitinib 5 mg twice daily and placebo. The x-axis represents time in weeks, and the y-axis shows response rate as a percentage with standard error. The tofacitinib group shows a higher and increasing response rate compared to the placebo group.*

FDA Label Image

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A line graph comparing the occurrence of disease flare over time between Tofacitinib 5 mg BID and placebo groups. The x-axis represents weeks (18 to 44), and the y-axis shows the percentage occurrence of disease flare. Error bars indicate standard error, and a p-value of 0.0007 is shown for Week 44, indicating statistical significance between groups.*

FDA Label Image

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Label for Tofacitinib Tablets 5 mg film-coated oral tablets by Zydus Pharmaceuticals USA Inc. The package contains 60 tablets, with an NDC of 70710-1243-6. The label includes dosage information, storage instructions, child-resistant packaging notice, and manufacturer details of Zydus Lifesciences Ltd., India.*

* 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.