Tofacitinib Tablet
Product Images NDC 51991-329

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 51991-329). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Breckenridge Pharmaceutical, Inc., 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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Chemical Structure (Tofacitinib 01)

Chemical structure diagram of Tofacitinib Citrate, showing the molecular arrangement of its chemical components as represented in the image.*

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Figure 1 (Tofacitinib 02)

A forest plot chart showing the ratio and 90% confidence intervals for area under the curve (AUC) and maximum concentration (Cmax) pharmacokinetic parameters of Tofacitinib across intrinsic factors such as weight, age, sex, race, and levels of renal and hepatic impairment. The x-axis is labeled 'Ratio relative to reference.'*

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Figure 2 (Tofacitinib 03)

A pharmacokinetic ratio plot showing the effect of coadministered drugs (Methotrexate, Midazolam, Levonorgestrel, Ethinyl Estradiol, Metformin) on the AUC and Cmax of Tofacitinib. The chart displays the ratio relative to reference with 90% confidence intervals for each interaction.*

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Figure 3 (Tofacitinib 04)

A scatter plot showing the pharmacokinetic ratio and 90% confidence intervals for Tofacitinib coadministered with various drugs, including ketoconazole, fluconazole, rifampin, methotrexate, tacrolimus, and cyclosporine. The x-axis represents the ratio relative to reference, ranging from 0 to 2.5, for parameters AUC and Cmax.*

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Figure 4 (Tofacitinib 05)

A line graph comparing response rates over six months between Tofacitinib tablets 5 mg taken twice daily and placebo. The y-axis represents response rates with standard error, while the x-axis shows months from 0 to 6. The graph displays higher response rates for Tofacitinib compared to placebo at each time point.*

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Figure 5 (Tofacitinib 06)

A line graph comparing the response rates over a 3-month period between Tofacitinib Tablets 5 mg BID and placebo. The x-axis represents visit months (0 to 3), and the y-axis shows response rate percentages with standard error bars. The Tofacitinib group shows a higher response rate increasing over time compared to placebo.*

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Figure 6 (Tofacitinib 07)

A line graph depicting response rates over weeks for Tofacitinib Tablets 5 mg twice daily compared to placebo. The y-axis shows response rate percentage with standard error, while the x-axis represents weeks from 0 to 16. The graph illustrates higher response rates with Tofacitinib versus placebo over time.*

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Figure 7 (Tofacitinib 08)

A line graph comparing the occurrence of disease flare percentage over weeks for Tofacitinib Tablets 5 mg taken twice daily versus placebo. The x-axis shows time points from week 18 to week 44, and the y-axis represents the occurrence of disease flare percentage with standard error bars. The graph indicates a consistently lower disease flare occurrence for Tofacitinib compared to placebo with statistical significance noted (p = 0.0007).*

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Principal Display Panel (5 mg Tablet Bottle Label)

Label for Tofacitinib Tablets 5 mg oral tablets by Breckenridge Pharmaceutical, Inc. The label includes storage instructions, dosage information, and a note for pharmacists to dispense the Medication Guide. The package contains 60 tablets and lists the NDC number 51991-329-06. Manufactured by Towa Pharmaceutical Europe in Spain and made in India.*

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Principal Display Panel (10 mg Tablet Bottle Label)

Tofacitinib Tablets 10 mg oral tablets packaging label by Breckenridge Pharmaceutical, Inc. The label includes storage instructions at 20°C to 25°C, prescription dispensing information, a barcode, and states the package contains 60 tablets. The label specifies a dosage of 10 mg tofacitinib per tablet (equivalent to 16.16 mg tofacitinib citrate). Manufacturing and distribution details are also noted.*

* 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.