Tofacitinib Tablet, Film Coated
Product Images NDC 60505-6263

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 60505-6263). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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

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This text provides important information about a medication containing 10 mg of tofacitinib per film-coated tablet. It mentions the recommended storage temperature and specifies not to repackage the tablets. The dosage and use instructions should be referred to the accompanying prescribing information. The medication is indicated for ulcerative colitis, and the pharmacist is instructed to dispense a medication guide to each patient. The tablets are manufactured by Apotex Inc in Toronto, Ontario, Canada, for Apotex Corp in Weston, Florida.*

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Btl-lbl-5mg-60s.jpg (Btl Lbl 5mg 60s)

The text is a description of Tofacitinib tablets containing 5 mg of tofacitinib (equivalent to 8.08 mg Tofacitinib Citrate), with storage instructions between 20°C to 25°C. It advises against repackaging and suggests consulting the prescribing information for dosage and usage details. The tablets are manufactured by Apotex Inc in Toronto, Ontario, Canada, for Apotex Corp in Weston, Florida. Pharmacies are instructed to dispense Medication Guide available online to each patient.*

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This text contains a list of drugs and their interaction with various substrates. It includes information on drug coadministration, PK parameters such as AUC and Cmax, as well as a ratio and 90% confidence interval. The text also indicates the ratio relative to the reference drug.*

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This text provides information on a study involving Tofacitinib 5 mg administered twice daily compared to a placebo. The study used non-responder imputation method where patients who withdrew from the study and those who did not show at least a 20% improvement in joint counts at Month 3 were considered failures.*

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Description not available.*

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This text provides information on the occurrence of disease flare in a study comparing Tofacitinib 5mg BID to a placebo, with data collected at weeks 18, 20, and 44. The occurrence of disease flare was found to be 100% in the Tofacitinib group and 90% in the placebo group at some point in the study. The statistical significance of the results is indicated by a p-value of 0.00007.*

FDA Label Image

Structure.jpg (Structure)

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