Ambrisentan Tablet, Film Coated
Product Images NDC 70710-1180

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Ambrisentan (NDC 70710-1180). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Zydus Pharmaceuticals Usa Inc., 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 depicted with molecular components including aromatic rings, methoxy group, carboxylic acid functional group, and methyl-substituted nitrogen-containing heterocyclic ring.*

FDA Label Image

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Chart showing the fold change and 90% confidence interval for pharmacokinetic parameters Cmax and AUC of ambrisentan when coadministered with various interacting drugs, including Cyclosporine, Mycophenolate Mofetil, Ketoconazole, Omeprazole, Rifampin, Ritonavir, Sildenafil, Tacrolimus, Tadalafil, and Warfarin, along with dosing recommendations such as limiting ambrisentan to 5 mg once daily with Cyclosporine or no dose adjustment for the others.*

FDA Label Image

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A forest plot depicting the fold change with 90% confidence intervals for pharmacokinetic parameters (Cmax, AUC, Emax, and AUEC) of various interacting drugs relative to the interacting drug alone. The drugs listed include Cyclosporine, Digoxin, Ethinylestradiol, Norethindrone, Mycophenolic acid, Ritonavir, Sildenafil, Desmethylsildenafil, Tadalafil, and Warfarin with its isomers S-Warfarin and R-Warfarin. The right column provides dosage adjustment recommendations, all indicating 'No dose adjustment.' The x-axis shows change relative to the interacting drug alone, ranging from 0.0 to 3.0.*

FDA Label Image

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Two line charts labeled ARIES-1 and ARIES-2 depict changes in meters over time (Baseline, Week 4, Week 8, Week 12) for Ambrisentan doses and placebo. ARIES-1 compares placebo, 5 mg, and 10 mg; ARIES-2 compares placebo, 2.5 mg, and 5 mg, showing dose-related increases versus placebo.*

FDA Label Image

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Two Kaplan-Meier survival curves comparing the event-free percentage over 12 weeks for Ambrisentan versus placebo from ARIES-1 and ARIES-2 studies. Both plots show higher event-free rates for Ambrisentan compared to placebo, with survival percentages and p-values indicating statistical differences. The number of subjects at risk is listed below each time point for both groups.*

FDA Label Image

5 mg (4ad0e26d A3b2 47d1 89a0 6e7e0697d5e4 06)

Ambrisentan Tablets 5 mg film-coated tablets label for oral use by Zydus Pharmaceuticals USA Inc. The package contains 30 tablets with a prescription only designation. The label includes dosage strength, directions for the pharmacist to dispense a Medication Guide, storage instructions, and manufacturer and distributor details.*

FDA Label Image

10 mg (4ad0e26d A3b2 47d1 89a0 6e7e0697d5e4 07)

Label for Ambrisentan Tablets 10 mg film-coated oral tablets by Zydus Pharmaceuticals USA Inc. The label shows the drug name, strength (10 mg), quantity (30 tablets), and prescription status (Rx only). It includes dosing instructions, storage information, and manufacturer details, indicating pills are child-resistant and to dispense with a medication guide.*

* 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.