Tofacitinib Tablet, Film Coated
Product Images NDC 33342-542

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 33342-542). 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.

FDA Label Image

654 (Tofacitinib 10mg 120s)

Tofacitinib 10 mg tablets film-coated packaging label showing the product name, strength, and quantity of 120 tablets. The label displays storage information, manufacturer details as Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc., along with barcode and usage advisories for ulcerative colitis.*

FDA Label Image

987 (Tofacitinib 10mg 60s)

Label for Tofacitinib Tablets 10 mg, oral film-coated tablets, manufactured by Macleods Pharmaceuticals Ltd. The label indicates the package contains 60 tablets. Storage instructions and prescribing information references are also present. The label features barcodes and manufacturing details from India, with Macleods Pharma USA as the distributor.*

FDA Label Image

877 (Tofacitinib 10mg 90s)

Packaging label for Tofacitinib Tablets 10 mg by Macleods Pharmaceuticals Limited. The label indicates 90 unit-dose tablets, with storage instructions and manufacturer details including Macleods Pharma USA, Inc. It highlights the product is Rx only and mentions that 10 mg strength is recommended only for ulcerative colitis. The label includes barcode and batch/expiration date fields.*

FDA Label Image

987 (Tofacitinib 5mg 120s)

Label for Tofacitinib 5 mg film-coated tablets, oral use, containing 120 tablets. The label indicates the active ingredient strength of 5 mg per tablet and notes the product is manufactured for Macleods Pharma USA, Inc. and by Macleods Pharmaceuticals Ltd. in India. It includes storage instructions and a medication guide website.*

FDA Label Image

987 (Tofacitinib 5mg 60s)

Tofacitinib Tablets 5 mg film-coated oral tablets packaging label by Macleods Pharmaceuticals Limited. The label indicates 60 tablets per bottle, with storage instructions and manufacturing details from India. Labeler is Macleods Pharma USA Inc., Princeton, NJ.*

FDA Label Image

987 (Tofacitinib 5mg 90s)

Tofacitinib Tablets 5 mg film-coated oral tablets unit-dose packaging from Macleods Pharmaceuticals Limited. The carton indicates a total of 90 tablets (9 x 10 unit-dose tablets). Label features include the Macleods Pharma USA logo, NDC number 33342-541-43, and manufacturing details for Macleods Pharmaceuticals Ltd in India.*

FDA Label Image

787 (Tofacitinib Figure 1)

A pharmacokinetic chart showing the ratio and 90% confidence intervals for drug exposure metrics (AUC and Cmax) of Tofacitinib in various intrinsic factor groups. Factors include body weight (40 kg and 140 kg), age (80 years), sex (female), race (Asian, Black, Hispanic), and levels of renal and hepatic impairment (mild, moderate, severe). The x-axis represents the ratio relative to a reference value.*

FDA Label Image

758 (Tofacitinib Figure 2)

A forest plot showing pharmacokinetic ratios and 90% confidence intervals for coadministered drugs with Tofacitinib. It compares area under the curve (AUC) and maximum concentration (Cmax) ratios relative to reference for Methotrexate, Midazolam, Levonorgestrel, Ethinyl Estradiol, and Metformin. A horizontal axis indicates ratio range from 0 to 2.*

FDA Label Image

222 (Tofacitinib Figure 3)

A scatter plot figure titled 'Impact of Other Drugs on the Pharmacokinetics of Tofacitinib.' The Y-axis lists coadministered drugs (CYP3A inhibitor ketoconazole, CYP3A & CYP2C19 inhibitor fluconazole, CYP inducer rifampin, methotrexate, tacrolimus, cyclosporine) with pharmacokinetic measures AUC and Cmax. The X-axis shows ratio relative to reference ranging from 0 to 2.5. Data points with 90% confidence intervals illustrate the effect of each drug on the pharmacokinetic parameters of Tofacitinib tablets.*

FDA Label Image

989 (Tofacitinib Figure 4)

A line graph showing response rates with standard error over 0, 1, 3, and 6 months for Tofacitinib Tablets 5 mg Twice Daily versus placebo. The vertical axis represents response rates with error margins, while the horizontal axis represents time in months. Tofacitinib shows higher response rates compared to placebo at all time points.*

FDA Label Image

985 (Tofacitinib Figure 5)

A line graph comparing response rates (%) over a 3-month period between Tofacitinib 5 mg twice daily (BID) and placebo. The x-axis represents months of visits (0 to 3), and the y-axis shows response rate percentages. The graph includes error bars indicating standard error for each data point.*

FDA Label Image

454 (Tofacitinib Figure 6)

A line graph showing response rates over 16 weeks comparing Tofacitinib 5 mg twice daily to placebo. The X-axis represents weeks (0 to 16) and the Y-axis shows response rate in percent (0 to 100%). The graph indicates higher response rates with Tofacitinib over placebo, with error bars for standard error at each time point.*

FDA Label Image

878 (Tofacitinib Figure 7)

A line graph comparing the occurrence of disease over time between patients treated with XELJANZ 5 mg BID (N=88) and placebo (N=85). The x-axis represents time from week 18 to week 44, and the y-axis shows the percentage of disease occurrence with standard error bars. The graph shows lower disease occurrence in the XELJANZ group compared to placebo, with a statistical significance indicated at week 44 (p = 0.0007).*

FDA Label Image

121 (Tofacitinib Structure)

Chemical structure of Tofacitinib citrate, showing the molecular arrangement of the Tofacitinib active ingredient combined with citrate.*

* 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.