Tofacitinib Tablet, Film Coated
Product Images NDC 33342-541

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 33342-541). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Macleods Pharmaceuticals 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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654 (Tofacitinib 10mg 120s)

This text pertains to Tofacitinib tablets in 10 mg strength, recommended for use in ulcerative colitis. It includes information on the medication guide, dosage, storage instructions, and manufacturer details. The tablets contain Tofacitinib 10 mg, equivalent to 16.16 mg of Tofacitinib Citrate. For more details, refer to the prescribing information available at www.macleodspharma.com/usa. The product is manufactured for Macleods Pharma USA, Inc. and Macleods Pharmaceuticals Ltd. in India.*

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987 (Tofacitinib 10mg 60s)

This is a description of a medication called Tofacitinib in tablet form with a concentration of 10 mg, recommended for use in ulcerative colitis. The medication guide can be found at www.macleodspharma.com/usa. Each tablet contains Tofacitinib equivalent to 16.16 mg of Tofacitinib Citrate. The recommended dosage and use should be followed as indicated in the prescribing information. The tablets should be stored between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). The product is manufactured in India and distributed by Macleods Pharma USA, Inc.*

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877 (Tofacitinib 10mg 90s)

The text contains information about Tofacitinib Tablets, which are recommended for ulcerative colitis treatment. The medication guide is available at www.macleodspharma.com/usa. The tablets come in a 90-unit dose package and each tablet contains 10mg of Tofacitinib. The product is manufactured in India by Macleods Pharmaceuticals Ltd. It is advised to store the tablets at 20° to 25°C (68° to 77°F). The text also mentions not repackaging the tablets and that the unit-dose package is not child-resistant.*

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987 (Tofacitinib 5mg 120s)

This is a description of a medication called Tofacitinib in tablet form with a dosage of 5 mg. The medication guide can be found at www.macleodspharma.com/usa. The tablets are available in a bottle containing 120 tablets. Each tablet contains Tofacitinib equivalent to 8.08 mg of Tofacitinib Citrate. The recommended storage temperature is between 15°C to 30°C (59°F to 86°F). The product is manufactured in India for Macleods Pharma USA, Inc., by Macleods Pharmaceuticals Ltd.*

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987 (Tofacitinib 5mg 60s)

Each tablet contains 5 mg of Tofacitinib Citrate. This medication is stored at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). The controlled room temperature should not be exceeded. Repackaging of the tablets is not recommended. The medication guide is available with the code number MP/IDRUGS/25/88/2020. This product is manufactured by Macleods Pharmaceuticals Ltd. in India and distributed by Macleods Pharma USA, Inc. Each bottle contains 60 tablets.*

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987 (Tofacitinib 5mg 90s)

This text refers to Macleods Pharma USA's Tofacitinib Tablets, which come in a 5 mg strength. The medication guide is available on their website. The tablets are a product of India and manufactured by Macleods Pharmaceuticals Ltd. Detailed dosage and usage information can be found in the accompanying prescribing information. The tablets should be stored within a specific temperature range and should not be repackaged. The package contains 90 unit-dose tablets.*

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787 (Tofacitinib Figure 1)

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758 (Tofacitinib Figure 2)

This is a list of drugs and their interactions, including methotrexate, midazolam, oral contraceptives containing levonorgestrel and ethinyl estradiol, and metformin, mentioning their effect on CYP3A, OCT & MATE substrate, and PK parameters like Ave Cmax. The ratios and 90% confidence levels are also provided for evaluation.*

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222 (Tofacitinib Figure 3)

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989 (Tofacitinib Figure 4)

This is a description of response rates (+/- standard error) for patients taking Tofacitinib Tablets 5 mg Twice Daily compared to Placebo over a period of 3 months. Non-responder imputation method was used, where patients who withdrew from the study or did not show at least a 20% improvement in joint counts at Month 3 were considered as failures.*

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985 (Tofacitinib Figure 5)

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454 (Tofacitinib Figure 6)

This text provides information about response rate in a treatment study comparing Tofacitinib 6 mg Twice Daily and Placebo over 8-12 weeks. The response rates ranged from 10% to 100%.*

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878 (Tofacitinib Figure 7)

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121 (Tofacitinib Structure)

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