Ticagrelor Tablet
Product Images NDC 71610-958

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 21 technical images submitted to the FDA as part of the official labeling for Ticagrelor (NDC 71610-958). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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

Label (71610 0958 41)

Label (71610 0958 41)
Ticagrelor 90 mg tablet package label showing 5400 tablets. The label includes NDC number 71610-958-41 and storage instructions to keep between 20-25 degrees Celsius in a light-resistant container. Manufactured by Apotex Inc., Toronto, Ontario, and packaged by Aphena Pharma, Cookeville, TN 38506. Label indicates prescription use only (RX Only).*
FDA Label Image

Aphena (Aphena)

FDA Label Image

Figure1.jpg (Figure1)

Figure1.jpg (Figure1)
A line graph showing cumulative percentage over days from the first study drug dose, comparing Ticagrelor 90 mg and Clopidogrel. The x-axis is labeled 'Days from First Study Drug Dose' (0 to 360), and the y-axis is labeled 'Cumulative %' (0 to 5%). Two lines represent Ticagrelor (solid line) and Clopidogrel (dashed line), with Ticagrelor consistently having a higher cumulative percentage. A table inset summarizes patient numbers and events for each drug at 12 months.*
FDA Label Image

Figure10.jpg (Figure10)

Figure10.jpg (Figure10)
A cumulative percentage line graph comparing Ticagrelor 90 mg tablets versus Clopidogrel over 360 days from randomization. The x-axis shows days from randomization, and the y-axis shows cumulative percentage. Two lines represent the cumulative percentage of patients with events for Ticagrelor and Clopidogrel. The inset shows numerical data for sample size, event counts, Kaplan-Meier percentages at 12 months, hazard ratio with confidence intervals, and p-value.*
FDA Label Image

Figure11.jpg (Figure11)

Figure11.jpg (Figure11)
A forest plot comparing the efficacy of Ticagrelor versus Clopidogrel across various patient subgroups and characteristics. The plot shows hazard ratios with 95% confidence intervals, including overall treatment effect, geographic region, ASA median dose, treatment approach, early PCI, post-randomization CABG, diabetes history, prior TIA/stroke, use of glycoprotein IIb/IIIa inhibitor, age group, sex, and race. The horizontal axis indicates Ticagrelor favoring the left and Clopidogrel favoring the right.*
FDA Label Image

Figure12.jpg (Figure12)

Figure12.jpg (Figure12)
A forest plot chart showing the hazard ratios (HR) with 95% confidence intervals (CI) comparing Ticagrelor and Clopidogrel effectiveness based on aspirin (ASA) dose in mg. Data are separated into US and Non-US regions with subgroups for ASA doses >=300 mg, between 100 and 300 mg, and <=100 mg. The chart visually represents HR values on a logarithmic scale where values less than 1 favor Ticagrelor and values greater than 1 favor Clopidogrel.*
FDA Label Image

Figure13.jpg (Figure13)

Figure13.jpg (Figure13)
A Kaplan-Meier cumulative percentage graph showing patient event rates over time (days from randomization) for Ticagrelor 90 mg, Ticagrelor 60 mg, and placebo groups. The x-axis represents days from randomization up to approximately 1300 days, and the y-axis shows cumulative percentages up to 11%. The graph includes lines for each treatment group with corresponding numbers at risk displayed below the x-axis. A legend box provides patient numbers, events, Kaplan-Meier percentages at 36 months, hazard ratios, and p-values for the comparison groups.*
FDA Label Image

Figure14.jpg (Figure14)

Figure14.jpg (Figure14)
A forest plot comparing the overall treatment effect of Ticagrelor versus placebo across various patient subgroups. The plot shows hazard ratios (HR) with 95% confidence intervals (CI) for demographics, clinical history, and treatment characteristics, illustrating the relative effectiveness of Ticagrelor in each category.*
FDA Label Image

Figure15.jpg (Figure15)

Figure15.jpg (Figure15)
A line graph comparing the cumulative percentage (%) of events over time (months from randomization, up to 54 months) between Ticagrelor and placebo groups. The graph includes a table below showing the number of subjects at risk at various time points for both groups.*
FDA Label Image

Figure16.jpg (Figure16)

Figure16.jpg (Figure16)
Forest plot depicting hazard ratios (HR) with 95% confidence intervals (CI) comparing Ticagrelor and placebo across various patient characteristics. The chart shows subgroups by age, sex, race, body mass index, geographic region, aspirin dose, HbA1c, renal function, insulin use, angina history, coronary artery disease status, history of PCI and CABG, smoking status, and diabetes duration, indicating the relative effect of Ticagrelor versus placebo in each subgroup.*
FDA Label Image

Figure17.jpg (Figure17)

Figure17.jpg (Figure17)
A Kaplan-Meier survival curve plot comparing Ticagrelor 90 mg twice daily (solid line) and placebo (dashed line). The y-axis shows cumulative percentage, and the x-axis shows days from randomization, up to 34 days. The graph includes event counts, numbers at risk over time, and cumulative percentage values for both groups.*
FDA Label Image

Figure18.jpg (Figure18)

Figure18.jpg (Figure18)
A forest plot comparing hazard ratios (HR) with 95% confidence intervals for Ticagrelor versus placebo across various patient subgroups. The plot includes categories such as age, sex, race, weight, BMI, geographic region, diagnosis, time from index event, diabetes status, hypertension, prior ischemic events, statin treatment, and smoking status, showing statistical comparisons between the Ticagrelor and placebo groups.*
FDA Label Image

Figure2.jpg (Figure2)

Figure2.jpg (Figure2)
A bar chart comparing the percentage of patients who experienced an event following CABG over several days, with two groups labeled T and C. The x-axis shows days (1 through 8+), and the y-axis shows the percentage of patients. Numerical values of events and population sizes are listed below each day for T and C groups.*
FDA Label Image

Figure3.jpg (Figure3)

Figure3.jpg (Figure3)
A Kaplan-Meier cumulative incidence plot showing the percentage of events over months from randomization, comparing Ticagrelor and placebo groups. The x-axis represents months up to 54, and the y-axis shows cumulative percentage. Lines depict Ticagrelor (solid) higher than placebo (dashed). A risk table below shows the number of subjects at risk at various time points.*
FDA Label Image

Figure4.jpg (Figure4)

Figure4.jpg (Figure4)
A Kaplan-Meier cumulative percent graph displaying event rates over days from randomization for Ticagrelor 90 mg twice daily versus placebo. The solid line represents Ticagrelor with higher cumulative events, and the dashed line represents placebo with lower cumulative events. The x-axis shows days from 0 to 34 and the y-axis shows cumulative percent from 0 to 1. A risk table below lists patient numbers at various time points.*
FDA Label Image

Figure5.jpg (Figure5)

Figure5.jpg (Figure5)
A line graph showing IPA (%) induced by 20 μM ADP over time (hours) for Ticagrelor 180 mg, Clopidogrel 600 mg, and placebo. Ticagrelor shows a rapid increase to near 90% by 2 hours and remains steady. Clopidogrel shows a gradual increase up to about 50% by 8 hours. Placebo remains low with minimal increase over time.*
FDA Label Image

Figure6.jpg (Figure6)

Figure6.jpg (Figure6)
A line graph depicting IPA (%) induced by 20 mcm ADP over a time course measured in days, with an inset graph showing the same measurement over hours. The main graph shows three data series marked by circles, triangles, and squares, with IPA peaking early then gradually declining over 10 days. The inset shows detailed early time point changes within 48 hours.*
FDA Label Image

Figure7.jpg (Figure7)

Figure7.jpg (Figure7)
A chart showing the mean effect and 90% confidence intervals for Ticagrelor and its metabolite AR-C124910XX on pharmacokinetic parameters (Cmax and AUC) across intrinsic factors such as age, gender, ethnicity, renal impairment, end-stage renal disease on hemodialysis, and mild hepatic impairment, along with dosing recommendations indicating no dose adjustment needed.*
FDA Label Image

Figure8.jpg (Figure8)

Figure8.jpg (Figure8)
A chart showing the mean effect and 90% confidence intervals of various interacting drugs on Ticagrelor and its metabolite AR-C124910XX. The x-axis represents the change relative to reference in pharmacokinetic parameters Cmax and AUC. The interacting drugs include CYP3A4 inhibitors, CYP3A4 inducers, aspirin, desmopressin, heparin, enoxaparin, P-gP and CYP3A inhibitors, morphine, and fentanyl, with dosing details and recommendations noted, such as avoiding concomitant use or no dose adjustment.*
FDA Label Image

Figure9.jpg (Figure9)

Figure9.jpg (Figure9)
A forest plot chart showing the interaction effects of various doses of Ticagrelor with different drugs, including Simvastatin, Atorvastatin, Levonorgestrel, Ethinyl Estradiol, Tolbutamide, Digoxin, and Cyclosporine. The x-axis represents the change relative to the interacting drug alone, with mean effect and 90% confidence intervals. Recommendations for dose adjustments are included next to each drug.*
FDA Label Image

Structure.jpg (Structure)

Structure.jpg (Structure)
Chemical structure diagram of Ticagrelor, showing its molecular framework with rings, functional groups, and fluorine atoms. The image depicts the detailed bonds and connectivity of the active ingredient Ticagrelor.*

* 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.