Tofacitinib Tablet, Film Coated
Product Images NDC 59651-459

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 59651-459). 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.

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Fig (Tofacitinib Fig1)

This text provides information about intrinsic factors related to weight, age, gender, race (Asian, Black, Hispanic), renal impairment levels (Mild, Moderate, Severe), and hepatic impairment levels (Mild, Moderate). It also mentions a ratio and 80% confidence interval. The details include weights of 40 kg and 140 kg, age of 80 years, and different levels of renal and hepatic impairments.*

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Fig (Tofacitinib Fig2)

This is a pharmacokinetic study evaluating the effects of coadministered drugs on the plasma concentrations of various substances such as Methotrexate, Midazolam, Oral Contraceptives (Levonorgestrel and Ethinyl Estradiol), Metformin, and others. The study includes the calculation of the area under the curve (AUC) and maximum concentration (Cmax) values along with the ratio and 90% confidence intervals for comparing the effects of the drugs.*

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Fig (Tofacitinib Fig3)

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Fig (Tofacitinib Fig4)

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Fig (Tofacitinib Fig5)

This is a figure showing the percentage of ACR20 responders by visit through Month 3 in Study PsA-1. The response rate for Tofacitinib 5 mg BID is compared to placebo.*

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Fig (Tofacitinib Fig6)

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Fig (Tofacitinib Fig7)

This is a text discussing the occurrence of disease flare in pediatric patients ages 2 and older with Juvenile Idiopathic Arthritis (JIA) during the double-blind phase of Study pcJIA-I. The study compares the frequency of disease flare between patients taking Tofacitinib 5mg BID (N=88) and those on a placebo (N=85) from Week 18 to Week 44. The results indicate a significant difference in disease flare occurrence, with a p-value of 0.0007. The text also clarifies that BID stands for twice daily, SE for standard error, and N for the total number of patients in each group.*

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Figure8 (Tofacitinib Fig8)

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Figure9 (Tofacitinib Fig9)

This provides information about a medication called Tofacitinib Tablets, which is recommended for ulcerative colitis at a dosage of 10 mg. It contains details about the ingredients, dosage instructions, storage conditions, and the distributor (Aurobindo Pharma USA, Inc.). The medication guide is to be dispensed separately to each patient. The tablets contain Tofacitinib 10 mg, equivalent to 16150 mg of tofacitnib citrate. It also includes instructions not to repackage the medication and to consult accompanying prescribing information for proper usage.*

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Str (Tofacitinib Str)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.