Tofacitinib Tablet, Film Coated, Extended Release
Product Images NDC 70710-1353

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 70710-1353). 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 depicting tofacitinib and its associated acid component. The diagram shows the molecular arrangement of atoms representing the active ingredient tofacitinib.*

FDA Label Image

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A scatter plot with error bars illustrating pharmacokinetic parameters (AUC and Cmax) ratios relative to reference for intrinsic factors like weight, age, sex, race, and organ impairment (renal and hepatic). The graph shows individual data points with 90% confidence intervals and corresponding dose adjustment recommendations for tofacitinib extended-release tablets by Zydus Pharmaceuticals USA Inc.*

FDA Label Image

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A pharmacokinetic ratio chart showing geometric mean ratios and 90% confidence intervals for AUC and Cmax of various coadministered drugs with tofacitinib. The chart lists methotrexate, CYP3A substrate midazolam, oral contraceptives levonorgestrel and ethinyl estradiol, and an OCT & MATE substrate metformin, with recommendations indicating no dose adjustment is needed for any listed drugs.*

FDA Label Image

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A chart showing pharmacokinetic (PK) drug interactions for tofacitinib extended-release tablets. It depicts the ratios and 90% confidence intervals for area under the curve (AUC) and maximum concentration (Cmax) with coadministered drugs (Ketoconazole, Fluconazole, Rifampin, Methotrexate, Tacrolimus, Cyclosporine). Recommendations for dose adjustments or immunosuppression risk are included.*

FDA Label Image

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A bar chart showing percentage of ACR20 responders in two studies comparing placebo (PBO), various doses (1, 3, 5, 10, 15 mg), ADA, and 20 mg dose groups. The vertical axis represents % ACR20 responders from 0 to 100, while the horizontal axis shows Study 1 and Study 2 data grouped by treatment categories.*

FDA Label Image

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

FDA Label Image

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A line graph comparing response rates over time (in months) between Tofacitinib 5 mg BID and placebo. The x-axis shows visit months (0 to 3), and the y-axis shows response rate in percentage with standard error bars. The graph displays higher response rates for Tofacitinib compared to placebo at all time points.*

FDA Label Image

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Tofacitinib Extended-Release Tablets 11 mg film-coated oral tablets packaging label. The label includes the NDC number 70710-1353-3, directions for pharmacist to dispense the Medication Guide, a count of 30 tablets, and manufacturer information for Zydus Pharmaceuticals USA Inc. Storage instructions and other drug details are printed on the label.*

FDA Label Image

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Label for Tofacitinib Extended-Release Tablets 22 mg by Zydus Pharmaceuticals USA Inc. The film-coated tablets are intended for oral administration, with 30 tablets per package. The label includes storage instructions, pharmacist dispensing guidance, and manufacturer details.*

* 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.