Ambrisentan Tablet, Film Coated
Product Images NDC 82009-141

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Ambrisentan (NDC 82009-141). 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, showing its molecular framework with aromatic rings, carboxyl group, and methyl substitutions.*

FDA Label Image

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A scatter plot chart displaying the fold change and 90% confidence intervals of pharmacokinetic parameters Cmax and AUC for Ambrisentan when taken with various interacting drugs. The x-axis shows the change relative to Ambrisentan alone, with most interactions indicating no dose adjustment except for Cyclosporine, which suggests limiting Ambrisentan to 5 mg once daily. The chart includes drugs such as Cyclosporine, Mycophenolate Mofetil, Ketoconazole, Omeprazole, Rifampin, Ritonavir, Sildenafil, Tacrolimus, Tadalafil, and Warfarin.*

FDA Label Image

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A chart showing fold change and 90% confidence intervals for pharmacokinetic parameters (Cmax, AUC, Emax, AUEC) of various interacting drugs relative to the drug alone. It includes drugs such as Cyclosporine, Digoxin, Ethinylestradiol, Norethindrone, Mycophenolic acid, Ritonavir, Sildenafil (and Desmethylsildenafil), Tadalafil, and Warfarin (including S-Warfarin and R-Warfarin). The chart also provides dosing recommendations, indicating no dose adjustment is needed for any listed interacting drug.*

FDA Label Image

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Two line graphs labeled ARIES-1 and ARIES-2 show changes in meters walked over time (Baseline to Week 12) for different doses of Ambrisentan compared to placebo. ARIES-1 compares placebo, 5 mg, and 10 mg doses, while ARIES-2 compares placebo, 2.5 mg, and 5 mg doses, each with error bars.*

FDA Label Image

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Two Kaplan-Meier survival curves labeled ARIES-1 and ARIES-2 show the percent of subjects event-free over 12 weeks for Ambrisentan versus placebo groups. Both graphs plot time (weeks) on the x-axis and event-free percentage on the y-axis. Ambrisentan shows higher event-free percentages compared to placebo throughout the period, with p-values of 0.030 and 0.005, respectively.*

FDA Label Image

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A text panel illustrating four contraceptive method options, each with listed choices. Options include intrauterine devices, hormonal methods, barrier methods combined with condoms, and partner vasectomy with additional contraceptive methods. The layout presents options in boxed lists labeled Option 1 through Option 4.*

FDA Label Image

5 mg (47d4a758 E84f 479d Affa B6a666c70173 07)

Ambrisentan 5 mg film-coated tablets label showing a package of 30 tablets. The label indicates oral use and prescription only status. It includes storage instructions, manufacturer information (Zydus Lifesciences Ltd., India), and the labeler Quallent Pharmaceuticals Health LLC, Grand Cayman. The label also cautions against splitting, crushing, or chewing tablets.*

FDA Label Image

10 mg (47d4a758 E84f 479d Affa B6a666c70173 08)

Label for Ambrisentan tablets, film coated, 10 mg strength. The label shows a package containing 30 tablets with oral route. It includes storage instructions, medication guide information, and manufacturer details for Zydus Lifesciences Ltd. and Quallent Pharmaceuticals Health LLC. The label also features barcodes and the Quallent Pharmaceuticals logo.*

* 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.