Tofacitinib Tablet, Film Coated, Extended Release
Product Images NDC 42799-970

Product Visual Gallery

This gallery contains 23 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 42799-970). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Edenbridge Pharmaceuticals Llc., 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 (11mg Bottle Label)

Label of Tofacitinib Extended-Release Tablets 11 mg manufactured for Edenbridge Pharmaceuticals LLC, Parsippany, NJ. The label indicates the package contains 30 film-coated extended-release tablets. Storage instructions specify 20°C to 25°C with permitted excursions. Additional details include dispensing the Medication Guide and barcode identification.*

FDA Label Image

1 (Figure 1)

A forest plot illustrating the impact of intrinsic factors on tofacitinib pharmacokinetics. The chart shows ratios and 90% confidence intervals for AUC and Cmax relative to reference values across factors such as weight (40 kg, 140 kg), age (80 years), sex (female), race (Asian, Black, Hispanic), and varying degrees of renal and hepatic impairment (mild, moderate, severe).*

FDA Label Image

1 (Figure 2)

A horizontal error bar chart titled "Impact of Tofacitinib on the Pharmacokinetics of Other Drugs" showing the ratio and 90% confidence interval for AUC and Cmax parameters of various coadministered drugs including Methotrexate, Midazolam, Levonorgestrel, Ethinyl Estradiol, and Metformin. The x-axis indicates the ratio relative to reference, ranging from 0 to 2, with data points around 1 indicating the relative pharmacokinetic changes.*

FDA Label Image

1 (Figure 3)

A chart titled 'Impact of Other Drugs on the Pharmacokinetics of Tofacitinib' showing the ratio and 90% confidence interval for AUC and Cmax pharmacokinetic parameters of Tofacitinib when coadministered with various drugs (Ketoconazole, Fluconazole, Rifampin, Methotrexate, Tacrolimus, Cyclosporine). The x-axis represents the ratio relative to reference, ranging from 0 to 2.5.*

FDA Label Image

1 (Figure 4)

A line graph titled 'Percentage of ACR20 Responders by Visit Through Month 6 in Study RA-IV' showing response rates over time in months. The x-axis represents months (0, 1, 3, 6), and the y-axis shows response rates (%) with standard error bars. Two lines compare Tofacitinib 5 mg twice daily and placebo groups, indicating higher response rates for Tofacitinib over 6 months.*

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1 (Figure 5)

A line graph showing the percentage of ACR20 responders over a 3-month period in Study PsA-I comparing Tofacitinib 5 mg BID and placebo. The x-axis represents visit months (0 to 3), and the y-axis shows the response rate percentage. Tofacitinib demonstrates a higher response rate than placebo at each visit.*

FDA Label Image

1 (Figure 6)

A line graph showing the percentage of ASAS20 responders over 16 weeks in patients with active AS, comparing tofacitinib 5 mg twice daily treatment and placebo. The graph plots response rate (%) on the vertical axis and weeks on the horizontal axis, illustrating higher response rates with tofacitinib than placebo throughout the study period, with error bars representing standard error.*

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1 (Table 10)

A data table titled 'Proportion of Adults with Active PsA with an ACR Response at Month 3 in Study PsA-I* [Nonbiologic DMARD Inadequate Responders (TNF Blocker-Naïve)]**' comparing response rates for Placebo and Tofacitinib 5 mg twice daily plus background nonbiologic DMARD across ACR20, ACR50, and ACR70 outcomes, including the number of participants, response rates, and differences with 95% confidence intervals.*

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1 (Table 11)

A data table titled 'Proportion of Adults with Active PsA with an ACR Response at Month 3 in Study PsA-II* (TNF Blocker Inadequate Responders)' comparing response rates for Placebo and Tofacitinib 5mg Twice Daily treatment groups, including number of patients and percentages for ACR20, ACR50, and ACR70 responses, along with difference percentages and 95% confidence intervals from placebo.*

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1 (Table 12)

A data table titled 'Components of ACR Response in Adults with Active PsA at Baseline and Month 3 in Studies PsA-I and PsA-II.' It compares treatment groups including placebo and Tofacitinib 5 mg twice daily across several parameters such as number of tender and swollen joints, patient assessments, HAQ-DI, physician's global assessment, and CRP levels, reported at baseline and month 3 for different responder categories in clinical studies.*

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1 (Table 13)

A data table titled 'Change from Baseline in HAQ-DI in Adults with Active PsA at Month 3 Studies PsA-I and PsA-II.' It presents least squares mean change from baseline in HAQ-DI scores comparing placebo and Tofacitinib 5 mg twice daily treatment groups across two study populations: Nonbiologic DMARD Inadequate Responders (TNF Blocker-Naïve) and TNF Blocker Inadequate Responders, with sample sizes and changes listed.*

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1 (Table 14)

A data table titled 'ASAS20 and ASAS40 Responses in Adults with Active AS at Week 16 in Study AS-I' comparing placebo and Tofacitinib 5 mg twice daily. It presents patient numbers, response percentages for ASAS20 and ASAS40 outcomes, and difference from placebo with 95% confidence intervals, including subset analysis for TNFi-IR patients.*

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1 (Table 15)

Table comparing ASAS components and other disease activity measures in adults with active ankylosing spondylitis at week 16 between placebo and Tofacitinib 5 mg twice daily groups, including baseline means, least squares mean changes, and differences from placebo with confidence intervals.*

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1 (Table 16)

A data table titled 'Results of RA Safety Study 1 in Adults with Rheumatoid Arthritis 50 years of Age and Older with at Least One Cardiovascular Risk Factor.' It compares safety endpoints including MACE, MI, stroke, cardiovascular death, malignancies, infections, thrombosis events, fractures, and osteoporotic fractures for patients treated with TNF Blocker, Tofacitinib 5 mg twice daily, and Tofacitinib 10 mg twice daily. The table lists incidence rates and hazard ratios with 95% confidence intervals for each endpoint.*

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1 (Table 17)

Data table titled 'How Supplied Information for Tofacitinib Extended-Release Tablets' detailing the dosage form, strength, description, bottle size, and NDC number. It describes Tofacitinib extended-release tablets as 11 mg, brownish red, oval, film-coated tablets with "11" debossed on one side, supplied in bottles of 30 tablets with NDC 42799-970-30.*

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1 (Table 2)

A data table titled 'Common Adverse Reactions in Clinical Trials of Tofacitinib for the Treatment of Rheumatoid Arthritis in Adults With or Without Concomitant DMARDs (0-3 Months).' It compares adverse reaction rates (percentage) for placebo, Tofacitinib 5 mg twice daily, and Tofacitinib 10 mg twice daily across preferred terms including upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension.*

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1 (Table 4)

A data table showing pharmacokinetic parameters of Tofacitinib tablets and extended-release tablets after multiple oral dosing. It compares dosing regimens of 5 mg and 10 mg twice daily for immediate-release tablets, and 11 mg and 22 mg once daily for extended-release tablets, listing AUC24, Cmax, Cmin, and Tmax values with variability and notes on data representation.*

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1 (Table 5)

A table titled 'Tofacitinib Exposure in Patients with RA, PsA, and AS After Administration of Tofacitinib 5 mg Twice Daily.' It presents pharmacokinetic parameters showing the geometric mean and coefficient of variation (%) for Tofacitinib 5 mg taken twice daily in patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis, specifically the AUC0-24,ss values (ng·h/mL) with corresponding variability percentages.*

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1 (Table 6)

Data table presenting the proportion of adults with moderate to severe active rheumatoid arthritis (RA) achieving an ACR response at months 3 and 6 across three clinical studies (RA-I, RA-IV, RA-V). The table compares placebo plus background DMARD or MTX versus Tofacitinib 5 mg twice daily with background therapy, showing ACR20, ACR50, and ACR70 response rates.*

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1 (Table 7)

Data table showing proportions and numbers of adults with moderate to severe active rheumatoid arthritis (RA) achieving DAS28-4(ESR) less than 2.6 at month 6 in study RA-IV, comparing Placebo + MTX and Tofacitinib 5 mg twice daily + MTX groups. It details responder percentages and joint activity counts among responders.*

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1 (Table 8)

A data table titled 'Components of ACR Response in Adults with Moderate to Severe Active RA at Baseline and Month 3 in Study RA-IV.' It compares clinical components between two groups: Placebo + MTX (N=160) and Tofacitinib 5 mg Twice Daily + MTX (N=321) at baseline and month 3. Components include number of tender and swollen joints, pain, patient global assessment, disability index (HAQ-DI), physician global assessment, and CRP levels, showing mean values with standard deviations.*

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1 (Table 9)

A data table titled 'Radiographic Changes in Adults with Moderate to Severe Active RA at Months 6 and 12 in Studies RA-IV and VI.' The table compares radiographic score changes (mTSS) at baseline and months 6 and 12 between placebo, MTX, and Tofacitinib 5 mg twice daily groups, showing means and standard deviations, and mean differences with confidence intervals.*

FDA Label Image

1 (Tofacitinib Citrate)

Chemical structure of tofacitinib citrate, the active ingredient in Tofacitinib extended release tablets 11 mg by Edenbridge Pharmaceuticals LLC.*

* 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.