Tofacitinib Tablet, Film Coated, Extended Release
Product Images NDC 73190-102

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 73190-102). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avkare, 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

1 (102 30)

Box label for Tofacitinib Extended-Release Tablets, 11 mg strength, film-coated tablets. The product is labeled for oral use and prescription only. The labeler is AvKARE. The package contains 30 tablets and includes storage instructions, cautionary statements, and a barcode.*

FDA Label Image

Figure1.jpg (Figure1)

A pharmacokinetic chart showing the ratio and 90% confidence interval for area under the curve (AUC) and maximum concentration (Cmax) across intrinsic factors such as weight, age, sex, race, and varying degrees of renal and hepatic impairment. The x-axis represents the ratio relative to reference from 0 to 4, illustrating the impact of these factors on drug exposure.*

FDA Label Image

Figure2.jpg (Figure2)

A ratio and 90% confidence interval chart showing pharmacokinetic parameters AUC and Cmax of drugs coadministered with tofacitinib. The drugs listed include Methotrexate, Midazolam (CYP3A substrate), Levonorgestrel (oral contraceptive), Ethinyl Estradiol, and Metformin (OCT & MATE substrate). The x-axis measures ratio relative to reference, ranging from 0 to 2.*

FDA Label Image

Figure3.jpg (Figure3)

A pharmacokinetic (PK) ratio and 90% confidence interval (CI) plot showing the effects of various coadministered drugs on the Area Under the Curve (AUC) and maximum concentration (Cmax) of tofacitinib. Drugs listed include ketoconazole, fluconazole, rifampin, methotrexate, tacrolimus, and cyclosporine, with their corresponding PK ratios relative to a reference on the x-axis.*

FDA Label Image

Figure4.jpg (Figure4)

A line graph depicting response rates over 0 to 6 months for patients taking XELJANZ 5 mg twice daily compared to placebo. The y-axis shows response rate in percentage with standard error. Filled circles represent XELJANZ, showing a higher response rate over time, while open circles represent placebo with lower response rates. The graph notes non-responder imputation and criteria for failure based on joint count improvement at Month 3.*

FDA Label Image

Figure5.jpg (Figure5)

A line graph showing response rate percentages over months of visits for two groups: Tofacitinib 5 mg BID and Placebo. The x-axis represents visit months 0 to 3, and the y-axis shows response rate percentages from 0% to 100%. Tofacitinib group shows a higher increasing response rate compared to placebo, with error bars indicating standard error.*

FDA Label Image

Figure6.jpg (Figure6)

A line graph showing response rates (percentage) over time in weeks for two treatments: XELJANZ 5 mg twice daily and placebo. The Y-axis represents response rate with standard error percent; the X-axis represents weeks from 0 to 16. XELJANZ shows a higher response rate increasing to about 65% at week 12, then slightly decreasing, while placebo response increases slowly to about 30% by week 12 and plateaus.*

FDA Label Image

Structure.jpg (Structure)

Chemical structure of tofacitinib citrate, the active ingredient in Tofacitinib extended-release tablets. The diagram shows the molecular arrangement, including rings, nitrogen atoms, methyl groups, and carboxylic acid groups typical of the citrate salt form.*

* 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.