Ambrisentan Tablet, Film Coated
Product Images NDC 42794-052

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Ambrisentan (NDC 42794-052). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sigmapharm Laboratories, 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

10mg1 (10mg1)

Ambrisentan tablets 10 mg film-coated oral tablets package label by Sigmapharm Laboratories, LLC. The label states each tablet contains 10 mg ambrisentan, with storage instructions, dispensing guidance, and package quantity of 30 tablets. Includes NDC 42794-052-08 and barcode.*

FDA Label Image

5mg1 (5mg1)

The label for Ambrisentan Tablets 5 mg from Sigmapharm Laboratories, LLC. It is a prescription human drug with film-coated tablets, dispensed as 30 tablets per container. The label includes storage instructions, a caution not to split, crush, or chew the tablets, and advises dispensing the attached Medication Guide to patients.*

FDA Label Image

Figure1 (Figure1)

Chemical structure of ambrisentan showing its molecular arrangement, including aromatic rings, a carboxylic acid group, and a heterocyclic ring with nitrogen atoms.*

FDA Label Image

Figure2 (Figure2)

A chart showing the fold change and 90% confidence interval in pharmacokinetic parameters (Cmax and AUC) of ambrisentan when coadministered with various interacting drugs. The chart lists drugs such as Cyclosporine, Mycophenolate Mofetil, Ketoconazole, Omeprazole, Rifampin, Ritonavir, Sildenafil, Tacrolimus, Tadalafil, and Warfarin, with corresponding recommendations mostly indicating no dose adjustment except for Cyclosporine, which recommends limiting ambrisentan to 5 mg once daily.*

FDA Label Image

Figure3 (Figure3)

A forest plot chart showing pharmacokinetic (PK) fold changes with 90% confidence intervals for various drugs interacting with the reference drug. The chart lists drugs such as Cyclosporine, Digoxin, Ethinylestradiol, Norethindrone, Mycophenolic acid, Ritonavir, Sildenafil, Tadalafil, and Warfarin, showing their Cmax and AUC values with fold changes relative to the interacting drug alone. The recommendation indicated for all interactions is 'No dose adjustment.'*

FDA Label Image

Figure4 (Figure4)

Two line graphs titled ARIES-1 and ARIES-2 depicting changes in meters over time at Baseline, Week 4, Week 8, and Week 12. The graphs compare placebo with different doses of ambrisentan (5 mg and 10 mg in ARIES-1; 2.5 mg and 5 mg in ARIES-2) showing mean distance changes along with error bars for each data point.*

FDA Label Image

Figure5 (Figure5)

Two Kaplan-Meier survival curves labeled ARIES-1 and ARIES-2 show event-free percentages over 12 weeks comparing Ambrisentan and placebo groups. Both graphs display higher event-free rates for Ambrisentan (97% and 94%) versus placebo (89% and 79%) with corresponding p-values of 0.030 and 0.005, respectively. Numbers at risk are shown below each time point.*

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Figure6 (Figure6)

Two Kaplan-Meier survival curves showing event-free percentages over time in weeks for combination therapy versus monotherapy. The top graph compares combination therapy with Ambrisentan monotherapy (blue line), and the bottom graph compares combination therapy with Tadalafil monotherapy (red line). Both graphs include hazard ratios (HR) and 95% confidence intervals indicating statistical comparison of treatments.*

FDA Label Image

Figure7 (Figure7)

A forest plot chart showing hazard ratios (HR) with 95% confidence intervals (CI) comparing Combination therapy against ambrisentan and tadalafil monotherapies for events including any event, death, hospitalization for worsening PAH, short term clinical worsening, and inadequate long term clinical response. The x-axis ranges from 0.25 to 4, indicating which treatment is favored based on HR values.*

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Figure8 (Figure8)

A forest plot showing hazard ratios with 95% confidence intervals for different subgroups comparing combination therapy versus ambrisentan or tadalafil monotherapy. The graph includes overall, gender (female, male), age groups (<65, ≥65 years), geographic regions (North America, Rest of World), WHO functional classes II & III, IPAH/HPAH, APAH, and 6-minute walk distance categories. Data points are plotted with markers and confidence intervals, indicating which treatment is favored across various subpopulations.*

FDA Label Image

Figure9 (Figure9)

A line graph showing exercise distance in meters over time (Baseline, Week 4, 8, 16, and 24) for three groups: Combination therapy, Ambrisentan monotherapy, and Tadalafil monotherapy. Combination therapy group shows the highest increase, followed by Ambrisentan monotherapy and Tadalafil monotherapy. Error bars indicate 95% confidence intervals.*

FDA Label Image

Mg1 (Mg1)

An instructional diagram illustrating four contraceptive method options, each listing combinations of device-based, hormonal, and barrier methods. Options include intrauterine devices, hormonal contraceptives (oral, patch, ring, injection), male condoms, diaphragms with spermicide, cervical caps with spermicide, and partner vasectomy, arranged in four labeled columns.*

* 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.