Tofacitinib Citrate Tablet, Film Coated
Product Images NDC 68254-5012

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Tofacitinib Citrate (NDC 68254-5012). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Concord Biotech 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

Image (Ad6e5467 Da25 405d A725 C95489d79aab 01)

Chemical structure of tofacitinib citrate, consisting of the tofacitinib molecule paired with the citrate ion, as depicted in a molecular diagram.*

FDA Label Image

Figure 1: Impact Of Intrinsic Factors On Tofacitinib Pharmacokinetics (Ad6e5467 Da25 405d A725 C95489d79aab 02)

A chart depicting pharmacokinetic ratios and 90% confidence intervals for tofacitinib citrate. It compares intrinsic factors like weight (40 kg vs 140 kg), age (80 years), sex (female), race (Asian, Black, Hispanic), and renal and hepatic impairment (mild, moderate, severe) in terms of AUC and Cmax ratios relative to a reference.*

FDA Label Image

Figure 2: Impact Of Tofacitinib On The Pharmacokinetics Of Other Drugs (Ad6e5467 Da25 405d A725 C95489d79aab 03)

A forest plot chart showing the effect of coadministered drugs including Methotrexate, CYP3A Substrate Midazolam, Oral Contraceptives Levonorgestrel and Ethinyl Estradiol, and OCT & MATE Substrate Metformin on AUC and Cmax pharmacokinetic parameters. The chart presents ratio and 90% confidence intervals of these drugs relative to a reference value along the x-axis from 0 to 2.*

FDA Label Image

Figure 3: Impact Of Other Drugs On The Pharmacokinetics Of Tofacitinib (Ad6e5467 Da25 405d A725 C95489d79aab 04)

A forest plot chart showing pharmacokinetic (PK) effects of coadministered drugs on Tofacitinib Citrate, with ratios and 90% confidence intervals for AUC and Cmax measures. Drugs listed include Ketoconazole, Fluconazole, Rifampin, Methotrexate, Tacrolimus, and Cyclosporine, with corresponding data points plotted relative to a reference ratio.*

FDA Label Image

Image (Ad6e5467 Da25 405d A725 C95489d79aab 05)

A line graph showing response rates with standard error over a 6-month period for Tofacitinib 5 mg taken twice daily compared to placebo. The response rates increase for both groups initially, with Tofacitinib showing higher rates throughout the timeline.*

FDA Label Image

Figure 5: Percentage Of Acr20 Responders By Visit Through Month 3 In Study Psa-i*,** (Ad6e5467 Da25 405d A725 C95489d79aab 06)

Line graph showing the response rate percentage over a 3-month period comparing Tofacitinib 5 mg BID to placebo. The graph plots response rate on the vertical axis and months on the horizontal axis, illustrating greater response rates for Tofacitinib compared to placebo across visits.*

FDA Label Image

Figure 6: Percentage Of Asas20 Responders Over Time Up To Week 16 In Patients With Active As In Study As-i (Ad6e5467 Da25 405d A725 C95489d79aab 07)

A line chart showing response rate (%) with standard error over a 16-week period comparing Tofacitinib 5 mg twice daily treatment and placebo. The x-axis represents weeks, and the y-axis represents response rate. The Tofacitinib group shows a higher and increasing response rate over time compared to the placebo group.*

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 (Ad6e5467 Da25 405d A725 C95489d79aab 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 graph shows percent occurrence with standard error bars, indicating lower disease flare rates for the Tofacitinib group compared to Placebo throughout the study period, with a p-value of 0.0007 at Week 44.*

FDA Label Image

Image (Ad6e5467 Da25 405d A725 C95489d79aab 09)

TOFACITINIB CITRATE film-coated tablets label showing 5 mg strength. The label includes storage instructions, dosage unit information indicating each tablet contains 5 mg tofacitinib (equivalent to 8.08 mg tofacitinib citrate), and that the package contains 28 tablets. Manufactured by Concord Biotech Limited, Gujarat, India. Also present are barcode, NDC number, and space for batch details.*

FDA Label Image

Image (Ad6e5467 Da25 405d A725 C95489d79aab 10)

Label for Tofacitinib Tablets 10 mg, film-coated oral tablets manufactured by Concord Biotech Limited. The label includes storage instructions, dosage form, strength, and packaging details for a bottle containing 28 tablets. It also displays the NDC number 68254-5012-1 and highlights use for ulcerative colitis.*

* 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.