Tofacitinib Citrate Tablet, Film Coated, Extended Release
Product Images NDC 50228-567

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Tofacitinib Citrate (NDC 50228-567). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sciegen Pharmaceuticals, 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

Figure 1 (Tofacitinib Fig1)

Figure 1 (Tofacitinib Fig1)
A pharmacokinetic (PK) forest plot showing the ratio and 90% confidence intervals for area under the curve (AUC) and maximum concentration (Cmax) of Tofacitinib citrate across intrinsic factors including weight (40 kg, 140 kg), age (80 years), sex (female), race (Asian, Black, Hispanic), and renal and hepatic impairment of varying severity. Ratios are plotted relative to reference values.*
FDA Label Image

Figure 2 (Tofacitinib Fig2)

Figure 2 (Tofacitinib Fig2)
A forest plot titled 'Impact of Tofacitinib on the Pharmacokinetics of Other Drugs' showing the pharmacokinetic ratios and 90% confidence intervals for coadministered drugs methotrexate, midazolam, levonorgestrel, ethinyl estradiol, and metformin. The x-axis represents the ratio relative to reference, ranging from 0 to 2. Both AUC and Cmax values are presented for each drug, illustrating changes due to tofacitinib coadministration.*
FDA Label Image

Figure 3 (Tofacitinib Fig3)

Figure 3 (Tofacitinib Fig3)
A scatter plot chart illustrating pharmacokinetic drug-drug interaction ratios and 90% confidence intervals for various drugs coadministered with tofacitinib citrate. The chart compares area under the curve (AUC) and peak concentration (Cmax) ratios relative to reference values for inhibitors, inducers, and other drugs such as ketoconazole, fluconazole, rifampin, methotrexate, tacrolimus, and cyclosporine.*
FDA Label Image

Figure (Tofacitinib Fig4)

Figure (Tofacitinib Fig4)
A line graph showing response rates over months with standard error bars comparing XELJANZ 5 mg twice daily (black circles) and placebo (white circles). The x-axis represents time in months (0, 1, 3, and 6), while the y-axis shows response rates. The graph illustrates higher response rates for XELJANZ compared to placebo across the time points.*
FDA Label Image

Figure (Tofacitinib Fig5)

Figure (Tofacitinib Fig5)
A line graph comparing response rates over a three-month period for Tofacitinib 5 mg BID and placebo. The x-axis represents visit months (0 to 3), and the y-axis shows response rate percentage. The graph illustrates increasing response rates for both groups, with Tofacitinib showing higher rates consistently.*
FDA Label Image

Figure 6 (Tofacitinib Fig6)

Figure 6 (Tofacitinib Fig6)
A line graph displaying response rate (%) over 16 weeks comparing XELJANZ 5 mg twice daily versus placebo. The x-axis represents weeks (0 to 16), and the y-axis shows response rate percentages with standard error bars. Two lines indicate treatment response: a solid line for XELJANZ and a dashed line for placebo, with XELJANZ showing consistently higher response rates throughout the study period.*
FDA Label Image

Package Label-principal Display Panel (11 mg)

Package Label-principal Display Panel (11 mg)
Label for Tofacitinib Extended-Release Tablets, 11 mg, in a 30-count package by ScieGen Pharmaceuticals, Inc. The label includes usage instructions, storage temperature (20°C to 25°C), dispensing guidelines, and a barcode with the NDC 50228-567-30, indicating prescription-only status.*
FDA Label Image

Package Label-principal Display Panel (11 mg)

Package Label-principal Display Panel (11 mg)
Label for Tofacitinib Extended-Release Tablets 11 mg from ScieGen Pharmaceuticals, Inc. The label includes dosage strength, packaging count of 1,000 tablets, storage instructions, and a barcode. The product is prescription-only with a medication guide advisory and a "NO VARNISH" note on the right side.*
FDA Label Image

Str (Tofacitinib Str)

Str (Tofacitinib Str)
Chemical structure of tofacitinib citrate, showing the molecular connectivity and arrangement of its atoms in the compound.*

* 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.