Tofacitinib Tablet, Film Coated, Extended Release
Product Images NDC 76333-111

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 76333-111). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Orient Pharma Co., Ltd. Yunlin Plant, 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

Fig 1. (Fig 1)

A forest plot illustrating pharmacokinetic (PK) ratios and 90% confidence intervals (CI) for tofacitinib based on various intrinsic factors including weight, age, sex, ethnicity, and degrees of renal and hepatic impairment. The variables measured are area under the curve (AUC) and maximum concentration (Cmax) ratios relative to reference values, with the x-axis representing the ratio scale from 0 to 4.*

FDA Label Image

Fig 2. (Fig 2)

A forest plot chart showing the ratio and 90% confidence intervals for area under the curve (AUC) and maximum concentration (Cmax) of various coadministered drugs relative to a reference. Drugs listed include Methotrexate, Midazolam (CYP3A substrate), Levonorgestrel (oral contraceptive), Ethinyl Estradiol, and Metformin (OCT & MATE substrate). The x-axis displays the ratio relative to reference from 0 to 2.*

FDA Label Image

Fig 3. (Fig 3)

A scatter plot chart showing the pharmacokinetic (PK) ratios and 90% confidence intervals of various coadministered drugs relative to a reference. The chart compares AUC and Cmax values for inhibitors and inducers such as Ketoconazole, Fluconazole, Rifampin, Methotrexate, Tacrolimus, and Cyclosporine, with a ratio scale from 0 to 2.5 on the x-axis.*

FDA Label Image

Fig 4. (Fig 4)

A line graph showing response rates with standard error over time in months. It compares two groups: one receiving XELJANZ 5 mg twice daily and a placebo group. The graph depicts higher response rates for the XELJANZ group throughout the 6-month period compared to placebo.*

FDA Label Image

Fig 5. (Fig 5)

A line graph depicting response rates over months (0 to 3) comparing Tofacitinib 5 mg BID and placebo. The x-axis represents visit months, and the y-axis shows response rates in percentage with standard error bars. The Tofacitinib line increases steadily and remains above the placebo line throughout.*

FDA Label Image

Fig 6. (Fig 6)

A line graph showing response rate percentages over weeks for two treatments: XELJANZ 5 mg twice daily and placebo. The x-axis represents weeks (0 to 16), and the y-axis shows response rate percentages with standard error bars. XELJANZ treatment shows a higher and increasing response rate compared to placebo.*

FDA Label Image

Structure. (Structure)

Chemical structure diagram showing the molecular structure of tofacitinib citrate, the active ingredient in the tofacitinib extended release tablet. The diagram includes the tofacitinib molecule connected with the citrate component, representing the complete chemical entity.*

FDA Label Image

Label 11 (Label 1)

Label for Tofacitinib 11 mg extended-release tablets, oral, film-coated by Orient Pharma Co., Ltd. The label indicates a 30-tablet package, with storage instructions at 20°C to 25°C (68°F to 77°F). The product is prescription only and the label includes the NDC 76333-111-15 and manufacturing address in Yunlin County, Taiwan.*

* 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.