Tofacitinib Tablet, Film Coated
Product Images NDC 73190-101

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 73190-101). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avkare, 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

1 (100 60)

Label for Tofacitinib Tablets 5 mg film-coated oral tablets by AvKARE. The label includes the NDC 73190-100-60 and a count of 60 tablets. It contains storage instructions, manufacturer information, and a barcode. The label also directs pharmacists to dispense the accompanying Medication Guide to each patient.*

FDA Label Image

1 (101 60)

Tofacitinib Tablets 10 mg film-coated oral tablets packaging label by AvKARE. The label shows a red and white design, specifies the 10 mg strength, and contains warnings, storage instructions at 20°C to 25°C, and manufacturing details by MSN Pharmaceuticals Inc. The package contains 60 tablets for prescription use only.*

FDA Label Image

1 (How Supplied)

A data table listing supplied information for Tofacitinib tablets, including dosage form, strength, description, bottle size, and NDC numbers. It describes Tofacitinib 5 mg tablets as white to off-white, round, biconvex, film-coated with debossed markings "T1" and "M", in 60-count bottles. Tofacitinib 10 mg tablets are blue, round, biconvex, film-coated with debossed markings "T2" and "M", also in 60-count bottles.*

FDA Label Image

Tofacitinib-figure-01 (Tofacitinib Figure 01)

A forest plot chart illustrating the pharmacokinetic (PK) parameters Area Under Curve (AUC) and maximum concentration (Cmax) for various intrinsic factors affecting Tofacitinib. The chart shows ratios and 90% confidence intervals for weight, age, sex, race, renal impairment, and hepatic impairment relative to reference values.*

FDA Label Image

Tofacitinib-figure-02 (Tofacitinib Figure 02)

A pharmacokinetic graph displaying the ratio and 90% confidence intervals of various coadministered drugs including Methotrexate, Midazolam, Levonorgestrel, Ethinyl Estradiol, and Metformin. The x-axis shows the ratio relative to reference from 0 to 2, with data points for AUC and Cmax parameters.*

FDA Label Image

Tofacitinib-figure-03 (Tofacitinib Figure 03)

A pharmacokinetic ratio and 90% confidence interval chart showing the effects of various coadministered drugs (Ketoconazole, Fluconazole, Rifampin, Methotrexate, Tacrolimus, Cyclosporine) on the area under the curve (AUC) and peak concentration (Cmax) of a referenced drug. The horizontal axis shows the ratio relative to the reference value.*

FDA Label Image

Tofacitinib-figure-04 (Tofacitinib Figure 04)

A response rate line graph comparing Tofacitinib 5 mg twice daily to placebo over six months. The y-axis shows response rates with standard error, and the x-axis shows time in months. The graph shows higher response rates for Tofacitinib compared to placebo at all time points, with data points at 1, 3, and 6 months.*

FDA Label Image

Tofacitinib-figure-05 (Tofacitinib Figure 05)

A line graph comparing response rates (%) over a 3-month period for Tofacitinib 5 mg BID versus placebo. The x-axis represents the visit month (0 to 3), and the y-axis shows response rates from 0% to 100%. Two lines illustrate increasing response rates for Tofacitinib and placebo, with error bars indicating variability.*

FDA Label Image

Tofacitinib-figure-06 (Tofacitinib Figure 06)

A line graph comparing response rates over 16 weeks between Tofacitinib 5 mg twice daily and placebo. The y-axis shows response rate percentage with standard error, and the x-axis shows weeks. Tofacitinib shows a higher response rate than placebo throughout the period.*

FDA Label Image

Tofacitinib-figure-07 (Tofacitinib Figure 07)

A line graph showing the occurrence of disease flare percentage over time from week 18 to week 44, comparing Tofacitinib 5 mg taken twice daily (BID) versus placebo. The graph includes two lines with error bars, one for Tofacitinib (N=88) and one for placebo (N=85), indicating the Tofacitinib group had a higher percentage of disease flare occurrence compared to placebo.*

FDA Label Image

Tafacitinib-structure (Tofacitinib Structure)

Chemical structure diagram of Tofacitinib, illustrating the molecular components and bonds of the active pharmaceutical ingredient Tofacitinib.*

* 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.