Adcirca Tablet
Product Images NDC 66302-467

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Adcirca (NDC 66302-467). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by United Therapeutics Corporation, 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

Adcirca 20mg Container 60 024 03

ADCIRCA 20 mg tablets label showing Tadalafil as the active ingredient. The label indicates 60 tablets per container, marketed by United Therapeutics Corporation and manufactured by Eli Lilly and Company. The packaging notes the dosage form as oral tablets, with the same active ingredient as Cialis. Additional details include directions to take two 20 mg tablets daily and storage instructions.*

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Structural Formula (Adcirca Chem V1)

Chemical structure of Tadalafil, the active ingredient in ADCIRCA 20 mg tablets by United Therapeutics Corporation. The diagram shows the molecular framework with aromatic rings and characteristic functional groups.*

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Figure 1 (Adcirca Fig1 V1)

A forest plot chart showing the mean differences in blood pressure (systolic and diastolic) between tadalafil and placebo treatments, including data for tadalafil 20 mg and 10 mg coadministered with various other drugs such as alcohol, alfuzosin, amlodipine, angiotensin II receptor blocker, doxazosin, tamsulosin, bendroflumethiazide, enalapril, and metoprolol. The x-axis displays relative differences from -20 to 20 mmHg, with confidence intervals plotted for each comparison.*

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Figure 2 (Adcirca Fig2 V1)

A chart showing fold change and 90% confidence intervals of tadalafil pharmacokinetic parameters (AUC and Cmax) when coadministered with various drugs, including CYP3A inhibitors (ritonavir, ketoconazole), CYP3A inducers (rifampin, bosentan), antacids, and H2 antagonists. The chart also provides dose adjustment recommendations based on drug interactions relative to tadalafil alone.*

FDA Label Image

Figure 3 (Adcirca Fig3 V1)

A forest plot chart illustrating fold changes and 90% confidence intervals (CI) for pharmacokinetic parameters AUC and Cmax, and bleeding time, for various coadministered drugs with no dose adjustment recommended. Drugs include CYP1A2 substrate Theophylline, CYP2C9 substrates R- and S-warfarin, CYP3A substrates Midazolam and Lovastatin, CYP2C9/CYP3A substrate Bosentan, P-glycoprotein substrate Digoxin, oral contraceptives Ethinyl estradiol and Levonorgestrel, and NSAID Aspirin. The X-axis represents change relative to coadministered drug alone, ranging from 0 to 2.*

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Figure 4 (Adcirca Fig4 V1)

A line graph depicting the mean change from baseline (in meters) over 16 weeks comparing placebo (N=82) and ADCIRCA 40 mg (N=79). The x-axis represents weeks (0, 4, 8, 12, 16), and the y-axis shows mean change from baseline ranging from -10 to 50 meters. Data indicates increasing improvement for ADCIRCA over time, with statistical significance noted at weeks 8, 12, and 16.*

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Figure 5 (Adcirca Fig5 V1)

A horizontal forest plot showing placebo-adjusted mean changes in 6-minute walk distance (meters) with 95% confidence intervals for ADCIRCA 40mg versus placebo across various subgroups. Subgroups include all ITT subjects, bosentan use, PAH etiology, baseline walk distance, gender, age, and baseline WHO functional class, with data points and confidence intervals displayed along a scale from -100 to 200 meters change.*

FDA Label Image

Figure 6 (Adcirca Fig6 V1)

A line graph showing the percentage of patients without clinical worsening over time in days, comparing ADCIRCA 40 mg, ADCIRCA 20 mg, and placebo groups. The vertical axis represents percentage without clinical worsening, the horizontal axis represents time to clinical worsening in days, with three different lines indicating the three groups.*

* 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.