Ambrisentan Tablet, Film Coated
Product Images NDC 82009-142

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Ambrisentan (NDC 82009-142). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Quallent Pharmaceuticals Health 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

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Chemical structure of ambrisentan, depicting its molecular components including aromatic rings, carboxylic acid group, and heterocyclic ring with nitrogen atoms and methyl substitutions.*

FDA Label Image

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A pharmacokinetic interaction chart showing fold change and 90% confidence intervals for ambrisentan with various interacting drugs. The chart compares Cmax and AUC values relative to ambrisentan alone, listing drugs such as Cyclosporine, Mycophenolate Mofetil, Ketoconazole, Omeprazole, Rifampin, Ritonavir, Sildenafil, Tacrolimus, Tadalafil, and Warfarin, along with dosing recommendations.*

FDA Label Image

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A chart showing the fold change and 90% confidence interval of pharmacokinetic parameters (Cmax, AUC) for various interacting drugs when taken with Ambrisentan. The x-axis represents the change relative to the interacting drug alone, with most values close to 1.0, indicating no significant change. The chart includes a recommendation column stating 'No dose adjustment' for all drugs listed.*

FDA Label Image

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Two line graphs labeled ARIES-1 and ARIES-2 show distance in meters on the y-axis from baseline to week 12 on the x-axis. Each graph compares placebo and varying doses of Ambrisentan (5 mg and 10 mg in ARIES-1; 2.5 mg and 5 mg in ARIES-2), illustrating changes over time with plotted points and error bars for each group.*

FDA Label Image

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Two Kaplan-Meier survival curves labeled ARIES-1 and ARIES-2 depict event-free percentages over 12 weeks, comparing Ambrisentan (solid line) versus placebo (dotted line). Both graphs show higher event-free rates for Ambrisentan (97% and 94%) than placebo (89% and 79%) at 12 weeks, with p-values 0.030 and 0.005 indicating statistical comparison. At-risk subject numbers at intervals are listed below each graph.*

FDA Label Image

5 mg (B63bb971 Aaf7 4158 Bd2e C544758fff99 06)

Ambrisentan 5 mg film-coated tablets label from Quallent Pharmaceuticals Health LLC. The label states the product name, strength (5 mg), dosage form (tablets), package quantity (30 tablets), and usage as prescription only (Rx only). It includes storage instructions, dispensing guidelines, and manufacturer information. The label features barcodes and a highlighted strength box in orange.*

FDA Label Image

10 mg (B63bb971 Aaf7 4158 Bd2e C544758fff99 07)

Ambrisentan 10 mg film-coated tablets label showing product name, strength, dosage form, and prescription-only status. The label includes pharmacist instructions, storage guidelines (20°C to 25°C), manufacturer details (Zydus Lifesciences Ltd., India; Quallent Pharmaceuticals Health LLC, Cayman Islands), and cautions against splitting, crushing, or chewing tablets. The NDC 82009-142-30 and package quantity of 30 tablets are also visible.*

* 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.