Tofacitinib Tablet, Film Coated
Product Images NDC 70069-842

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 70069-842). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Somerset Therapeutics, Llc, 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 of Tofacitinib shown as a two-dimensional molecular diagram with labeled atoms and bonds, including a citrate component, representing the active pharmaceutical ingredient tofacitinib citrate.*

FDA Label Image

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A forest plot chart depicting pharmacokinetic (PK) parameters, specifically AUC and Cmax ratios and their 90% confidence intervals (CI), relative to reference groups. Variables analyzed include intrinsic factors such as weight (40 kg and 140 kg), age (80 years), sex (female), race (Asian, Black, Hispanic), and levels of renal and hepatic impairment (mild, moderate, severe). Each data point shows a ratio and interval along a horizontal axis ranging from 0 to 4, highlighting variability of PK measures with respect to these factors.*

FDA Label Image

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Pharmacokinetic chart displaying the ratios and 90% confidence intervals of AUC and Cmax for tofacitinib when coadministered with various drugs, including methotrexate, midazolam, levonorgestrel, ethinyl estradiol, and metformin, relative to a reference.*

FDA Label Image

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A comparative pharmacokinetic (PK) chart showing the ratio and 90% confidence interval (CI) of area under the curve (AUC) and maximum concentration (Cmax) for tofacitinib when coadministered with various drugs: Ketoconazole, Fluconazole, Rifampin, Methotrexate, Tacrolimus, and Cyclosporine. The horizontal axis represents the ratio relative to a reference value.*

FDA Label Image

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A line graph comparing the response rates over 6 months for Tofacitinib 5 mg twice daily versus placebo. The y-axis shows response rate as a percentage with standard error, and the x-axis shows time in months. Tofacitinib shows higher response rates at months 1, 3, and 6 compared to placebo.*

FDA Label Image

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A line graph comparing response rates (%) over 3 months between Tofacitinib 5 mg BID and placebo groups. The x-axis shows visit months (0, 0.5, 1, 2, 3) and the y-axis shows response rate with standard error bars. The Tofacitinib group shows higher response rates than placebo across visits.*

FDA Label Image

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A line graph displaying response rates (%) over a 16-week period. The x-axis represents weeks, and the y-axis shows response rate percentages. Two treatment groups are shown: Tofacitinib 5 mg twice daily, which shows a higher response rate over time, and a placebo group with lower response rates, both with error bars indicating variability.*

FDA Label Image

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A line graph comparing the occurrence of disease flare percentages over time between Tofacitinib 5 mg BID and placebo groups from week 18 to week 44. The graph shows lower disease flare occurrence in the Tofacitinib group versus placebo, with error bars indicating standard error. A significant p-value (0.0007) is noted at week 44.*

FDA Label Image

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Label for Tofacitinib Tablets 5 mg by Somerset Therapeutics LLC. The oral film-coated tablets come in a package of 60. Label includes storage instructions, dosing note, manufacturing details, and a QR code for the medication guide.*

FDA Label Image

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Label for Tofacitinib Tablets 10 mg by Somerset Therapeutics LLC. Oral film-coated tablets packaged as 60 count. Label indicates the medication is for prescription use only and highlights its recommended use in Ulcerative Colitis. Storage instructions and manufacturer details (Somerset, NJ) are included, along with a barcode and QR code for medication guide.*

* 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.