Tofacitinib Tablet, Extended Release
Product Images NDC 59651-685

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 59651-685). 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

Figure 1 (Tofacitinib Fig1)

This text provides information on intrinsic factors such as weight, age, gender, race, and various impairments (renal and hepatic) that may affect a person's physiological characteristics. Additionally, it mentions pharmacokinetic parameters like Area under the curve (AUC) and maximum concentration (Cmax). It seems to be part of a study or documentation analyzing the impact of these factors on certain ratios with a 90% confidence interval.*

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Figure 2 (Tofacitinib Fig2)

This information is a comparison of pharmacokinetic parameters when drugs are coadministered. It includes data on methotrexate, midazolam, oral contraceptives, levonorgestrel, ethinyl estradiol, and metformin, showing the area under the curve (AuC) and maximum concentration (Cmax). The provided ratios and 90% confidence intervals are crucial for evaluating the impact of coadministration on drug exposure levels.*

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Figure 3 (Tofacitinib Fig3)

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Figure (Tofacitinib Fig4)

This is a comparison of response rates after three months of treatment with Tofacitinib 5 mg twice daily versus placebo.*

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Figure (Tofacitinib Fig5)

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Figure 6 (Tofacitinib Fig6)

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Package Label-principal Display Panel (11 mg)

This is a description of a medication product containing Tofacitinib 11 mg in extended-release tablet form. The tablets are film-coated and distributed by Aurobindo Pharma USA, Inc. The dosage and use instructions are provided, and it is recommended to store the tablets at a temperature range of 20° to 25°C (68° to 77°F). The packaging includes information on GTIN, Serial Number, Expiry Date, and LOT in human-readable along with 2D coding. The product is made in India and includes a Medication Guide for patients.*

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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.