Tofacitinib Citrate Tablet, Film Coated, Extended Release
Product Images NDC 0574-1811

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Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tofacitinib Citrate (NDC 0574-1811). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Padagis Us 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.

Product Images & Figures Index

FDA Label Image

Chemical-structure (Chemical Structure)

Chemical-structure (Chemical Structure)
Chemical structure of tofacitinib citrate shown as a molecular diagram combining the tofacitinib moiety with citrate groups, indicating the active ingredient of the 11 mg extended release tablets by Padagis US LLC.*
FDA Label Image

Figure-1 (Figure 1)

Figure-1 (Figure 1)
A pharmacokinetic chart depicting the ratio and 90% confidence interval (CI) for various intrinsic factors affecting the area under the curve (AUC) and maximum concentration (Cmax) of Tofacitinib Citrate. The chart includes factors such as weight (40 kg and 140 kg), age (80 years), sex (female), race (Asian, Black, Hispanic), and degrees of renal and hepatic impairment (mild, moderate, severe), all plotted against a ratio relative to reference from 0 to 4.*
FDA Label Image

Figure-2 (Figure 2)

Figure-2 (Figure 2)
A forest plot chart showing the pharmacokinetic ratios and 90% confidence intervals (CI) for coadministered drugs Methotrexate, Midazolam, Levonorgestrel, Ethinyl Estradiol, and Metformin. The chart compares AUC and Cmax values relative to reference, illustrating the impact of Tofacitinib Citrate on these drugs' pharmacokinetics.*
FDA Label Image

Figure-3 (Figure 3)

Figure-3 (Figure 3)
A pharmacokinetic (PK) drug interaction chart showing the ratio and 90% confidence interval (CI) for area under the curve (AUC) and Cmax of tofacitinib citrate when coadministered with various drugs, including ketoconazole, fluconazole, rifampin, methotrexate, tacrolimus, and cyclosporine, relative to a reference.*
FDA Label Image

Figure-4 (Figure 4)

Figure-4 (Figure 4)
A line graph showing response rates with standard error over time in months for two groups: Tofacitinib tablets 5 mg twice daily and placebo. The response rate increases from 0 to 1 month, peaking around 3 months, then slightly decreases at 6 months for both groups, with higher response rates observed for Tofacitinib compared to placebo.*
FDA Label Image

Figure-5 (Figure 5)

Figure-5 (Figure 5)
A line graph comparing response rates over months for Tofacitinib 5 mg BID and placebo. The x-axis shows visit months (0 to 3) and the y-axis represents response rate percentages. The Tofacitinib line rises steadily higher than the placebo line across the visits, each with error bars indicating variability.*
FDA Label Image

Figure-6 (Figure 6)

Figure-6 (Figure 6)
A line graph depicting response rates over a 16-week period, comparing Tofacitinib Tablets 5 mg twice daily to placebo. The x-axis shows the weeks (0, 2, 4, 8, 12, 16), and the y-axis represents the response rate percentage. Solid and dashed lines with error bars illustrate the trends for Tofacitinib and placebo, respectively.*
FDA Label Image

Label (Label)

Label (Label)
Tofacitinib Extended-Release Tablets 11 mg film-coated oral tablets in a 30-count package. The label indicates this is a prescription drug manufactured for Padagis US LLC, with manufacturing by Haimen Pharma Inc. The label includes dosage strength, packaging details, and storage instructions, featuring the Padagis logo.*

* 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.