Tofacitinib Citrate Tablet, Film Coated
Product Images NDC 85972-121

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Tofacitinib Citrate (NDC 85972-121). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Stellon Biotech 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

Image (9d643ba7 2cb4 495a B96d 3c1f2832442f 01)

Chemical structure of Tofacitinib citrate, showing the molecular arrangement of the active ingredient Tofacitinib in combination with citrate.*

FDA Label Image

Figure 1: Impact Of Intrinsic Factors On Tofacitinib Pharmacokinetics (9d643ba7 2cb4 495a B96d 3c1f2832442f 02)

A scatter plot with error bars showing pharmacokinetic (PK) ratios and 90% confidence intervals for tofacitinib citrate under various intrinsic factors such as weight (40 kg, 140 kg), age (80 years), sex (female), race (Asian, Black, Hispanic), and different levels of renal and hepatic impairment (mild, moderate, severe). The x-axis represents the ratio relative to reference for AUC and Cmax values.*

FDA Label Image

Figure 2: Impact Of Tofacitinib On The Pharmacokinetics Of Other Drugs (9d643ba7 2cb4 495a B96d 3c1f2832442f 03)

A forest plot showing pharmacokinetic drug interaction ratios and 90% confidence intervals for various coadministered drugs relative to reference values. The drugs included are Methotrexate, CYP3A substrate Midazolam, Oral contraceptives Levonorgestrel and Ethinyl Estradiol, and OCT & MATE substrate Metformin, with measurements for AUC and Cmax where applicable.*

FDA Label Image

Figure 3: Impact Of Other Drugs On The Pharmacokinetics Of Tofacitinib (9d643ba7 2cb4 495a B96d 3c1f2832442f 04)

A chart showing pharmacokinetic (PK) ratios and 90% confidence intervals for coadministered drugs with tofacitinib citrate. Drugs listed include CYP3A substrate ketoconazole, CYP3A & CYP2C19 inhibitor fluconazole, CYP inducer rifampin, methotrexate, tacrolimus, and cyclosporine. The x-axis represents ratio relative to reference, with values from 0 to 2.5.*

FDA Label Image

Image (9d643ba7 2cb4 495a B96d 3c1f2832442f 05)

A line graph comparing response rates with standard error over 6 months for Tofacitinib 5 mg twice daily and placebo groups. The vertical axis represents response rates, and the horizontal axis shows time in months, illustrating higher response rates for Tofacitinib versus placebo.*

FDA Label Image

Figure 5: Percentage Of Acr20 Responders By Visit Through Month 3 In Study Psa-i*,** (9d643ba7 2cb4 495a B96d 3c1f2832442f 06)

A line graph showing the response rate over a 3-month period comparing Tofacitinib 5 mg BID and placebo. The x-axis represents the visit time in months, and the y-axis shows the response rate percentage with standard error bars. Tofacitinib demonstrates a higher response rate than placebo throughout the study period.*

FDA Label Image

Figure 6: Percentage Of Asas20 Responders Over Time Up To Week 16 In Patients With Active As In Study As-i (9d643ba7 2cb4 495a B96d 3c1f2832442f 07)

Line graph comparing response rates over 16 weeks between Tofacitinib 5 mg twice daily and placebo. The vertical axis shows response rate as percent plus/minus standard error, and the horizontal axis shows weeks. Response rates increase over time for both groups, with Tofacitinib showing higher response rates at each time point compared to placebo.*

FDA Label Image

Figure 7: Occurrence Of Disease Flare In Pediatric Patients 2 Years Of Age And Older With Jia By Visit From Week 18 To Week 44 In The Double-blind Phase In Study Pcjia-i (9d643ba7 2cb4 495a B96d 3c1f2832442f 08)

A line graph comparing the occurrence of disease flare over time (Weeks 18 to 44) between two groups: Tofacitinib 5 mg BID (N=88) and Placebo (N=85). The y-axis shows percentage occurrence with error bars representing standard error. The Tofacitinib group shows consistently lower disease flare rates than placebo, with a significant p-value of 0.0007 indicated near Week 44.*

FDA Label Image

Image (9d643ba7 2cb4 495a B96d 3c1f2832442f 09)

Label for Tofacitinib Tablets 5 mg oral film-coated tablets, containing 60 tablets per bottle. Manufactured for Stellon Biotech Inc., Woodcliff Lake, NJ, USA, and by Concord Biotech Limited, Gujarat, India. Includes storage instructions, NDC 85972-121-60, and a QR code linking to the medication guide. Marked Rx only.*

FDA Label Image

Image (9d643ba7 2cb4 495a B96d 3c1f2832442f 10)

Tofacitinib Tablets 10 mg film-coated oral tablets label shows storage instructions (20°C to 25°C), dosage note, and quantity of 60 tablets. Manufactured for Stellon Biotech Inc., Woodcliff Lake, NJ, with manufacturing by Concord Biotech Limited, Gujarat, India. Includes Rx only notice, barcode, QR code linking to medication guide, and company 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.