Ambrisentan Tablet, Film Coated
Product Images NDC 70710-1179

8 FDA label images from Zydus Pharmaceuticals Usa Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Ambrisentan (NDC 70710-1179). 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, showing its molecular configuration with aromatic rings, methoxy, carboxyl, and methyl substituents as part of the compound used in the tablet form of the medication.*
FDA Label Image

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A pharmacokinetic (PK) chart displaying fold changes with 90% confidence intervals for Cmax and AUC of Ambrisentan when coadministered with various interacting drugs. The chart compares changes relative to Ambrisentan alone, listing drugs like Cyclosporine, Mycophenolate Mofetil, Ketoconazole, Omeprazole, Rifampin, Ritonavir, Sildenafil, Tacrolimus, Tadalafil, and Warfarin, along with dosing recommendations.*
FDA Label Image

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A plot showing fold changes and 90% confidence intervals in pharmacokinetic parameters (Cmax, AUC, Emax, AUEC) of various interacting drugs (including Cyclosporine, Digoxin, Ethinylestradiol, Norethindrone, Mycophenolic acid, Ritonavir, Sildenafil, Desmethylsildenafil, Tadalafil, and Warfarin) when administered with ambrisentan. The x-axis represents change relative to the interacting drug alone, with a dotted line at 1.0 indicating no change. The recommendations column notes no dose adjustments are needed for these drug interactions.*
FDA Label Image

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Two line graphs labeled ARIES-1 and ARIES-2 showing changes in meters over time from baseline to week 12. The graphs compare placebo with different doses of Ambrisentan: ARIES-1 with 5 mg and 10 mg, and ARIES-2 with 2.5 mg and 5 mg. Both graphs display mean values with error bars, illustrating dose-dependent effects over the study period.*
FDA Label Image

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Two Kaplan-Meier event-free survival curves comparing Ambrisentan and placebo groups over 12 weeks in clinical trials ARIES-1 and ARIES-2. The graphs show percent event-free on the y-axis and time in weeks on the x-axis, with Ambrisentan consistently higher than placebo. Numbers at risk are listed below each time point for both groups.*
FDA Label Image

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A text panel presenting four contraceptive method options. Each option lists combinations of birth control methods including intrauterine devices, sterilization, hormonal contraceptives (oral, patch, ring, injection), barrier methods with spermicide (diaphragm, cervical cap), male condom, and partner vasectomy. The layout organizes options by combining methods recommended for contraception.*
FDA Label Image

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Label for Ambrisentan Tablets 5 mg, film-coated oral tablets, provided in a container of 30 tablets. The label includes the NDC 70710-1179-3, manufacturer Cadila Healthcare Ltd. (India), and distributor Zydus Pharmaceuticals (USA) Inc. Storage instructions and usage cautions are also visible. The label features a picture of a pink round tablet with the imprint '1179'.*
FDA Label Image

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Ambrisentan 10 mg film-coated tablets label showing the product name, strength, and dosage form. The label states the package contains 30 tablets for oral use, marked Rx only. It includes manufacturer information for Cadila Healthcare Ltd., India, and distributor details for Zydus Pharmaceuticals (USA) Inc. There are usage instructions, storage conditions, and a depiction of the tablet with imprint 1180. Two barcodes are present on the label.*

* 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.