Tofacitinib Tablet, Film Coated
Product Images NDC 59651-460

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 59651-460). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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 (Tofacitinib Fig1)

A forest plot chart illustrating pharmacokinetic ratios (AUC, Cmax) with 90% confidence intervals for Tofacitinib under various intrinsic factors such as weight (40 kg, 140 kg), age (80 years), sex (female), ethnicities (Asian, Black, Hispanic), renal impairment levels (mild, moderate, severe), and hepatic impairment (mild, moderate). The x-axis shows the ratio relative to reference from 0 to 4, visualizing how these factors affect drug exposure.*

FDA Label Image

Fig (Tofacitinib Fig2)

A forest plot chart depicting pharmacokinetic data comparing area under the curve (AUC) and maximum concentration (Cmax) ratios with 90% confidence intervals for various coadministered drugs relative to reference. The drugs include Methotrexate, Midazolam (CYP3A substrate), Levonorgestrel and Ethinyl Estradiol (oral contraceptives), and Metformin (OCT & MATE substrate). The x-axis represents the ratio relative to reference from 0 to 2.*

FDA Label Image

Fig (Tofacitinib Fig3)

A forest plot showing the pharmacokinetic interaction ratios and 90% confidence intervals for TOFACITINIB when coadministered with various drugs. The chart lists CYP3A inhibitors (Ketoconazole), CYP3A & CYP2C19 inhibitors (Fluconazole), CYP Inducer (Rifampin), Methotrexate, Tacrolimus, and Cyclosporine, with AUC and Cmax ratios relative to reference displayed on the x-axis from 0 to 2.5.*

FDA Label Image

Fig (Tofacitinib Fig4)

A line graph showing the percentage of ACR20 responders over six months in Study RA-IV comparing Tofacitinib Tablets 5 mg twice daily versus placebo. The X-axis represents months (0, 3, 6), and the Y-axis shows response rates with standard error bars. Tofacitinib shows higher response rates across time than placebo.*

FDA Label Image

Fig (Tofacitinib Fig5)

Line graph showing the percentage of ACR20 responders over three months in a PsA-I study comparing Tofacitinib 5 mg BID versus placebo. The x-axis represents months of visit (0 to 3), and the y-axis shows the response rate percentage. Tofacitinib group shows a higher response rate increasing over time compared to placebo.*

FDA Label Image

Fig (Tofacitinib Fig6)

A line chart displaying the percentage of ASAS20 responders over time up to week 16 in patients with active ankylosing spondylitis (AS) in Study AS-1. The x-axis shows weeks (0, 2, 4, 8, 12, 16) and the y-axis shows response rate percentage (0-100%). Two lines compare response rates: Tofacitinib 5 mg twice daily and placebo, with Tofacitinib showing a higher response rate over time.*

FDA Label Image

Fig (Tofacitinib Fig7)

A line chart titled '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.' The graph shows percent occurrence of disease flare over time (weeks 18 to 44) comparing two groups: Tofacitinib 5 mg BID (N=88) and placebo (N=85). The Tofacitinib group shows lower flare rates consistently than placebo, with data points including standard error bars and a p-value of 0.0007 noted at week 44.*

FDA Label Image

Figure8 (Tofacitinib Fig8)

Label for Tofacitinib Tablets 5 mg film-coated tablets, packaged in a quantity of 60 tablets. The label displays the NDC number 59651-459-60 and indicates prescription use only. Distributed by Aurobindo Pharma USA, Inc., the label includes storage instructions, prescribing information references, and a medication guide note.*

FDA Label Image

Figure9 (Tofacitinib Fig9)

Label for Tofacitinib Tablets 10 mg, film-coated oral tablets, in a container of 60 tablets by Aurobindo Pharma Limited. The label includes storage instructions, prescribing information notes, and distributor details for Aurobindo Pharma USA, Inc. It has barcode and overprinting areas marked for coding.*

FDA Label Image

Str (Tofacitinib Str)

Chemical structure of tofacitinib citrate, showing the molecular arrangement of the tofacitinib molecule paired with citric acid.*

* 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.