Ambrisentan Tablet, Film Coated
Product Images NDC 0378-4270

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Ambrisentan (NDC 0378-4270). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan Pharmaceuticals 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

Ambrisentan Structural Formula (Image 01)

Chemical structure of ambrisentan, showing the molecular arrangement including aromatic rings, methoxy group, carboxylic acid, and heterocyclic components with methyl substitutions.*

FDA Label Image

Figure 2: Effects Of Other Drugs On Ambrisentan Pharmacokinetics (Image 02)

A pharmacokinetic interaction chart showing fold changes and 90% confidence intervals for various drugs interacting with ambrisentan. It compares Cmax and AUC changes relative to ambrisentan alone for drugs like cyclosporine, mycophenolate mofetil, ketoconazole, omeprazole, rifampin, ritonavir, sildenafil, tacrolimus, tadalafil, and warfarin. Recommendations regarding dose adjustments, mostly indicating no dose adjustment except for cyclosporine, are included.*

FDA Label Image

Figure 3: Effects Of Ambrisentan On Other Drugs (Image 03)

A pharmacokinetic chart displaying fold changes and 90% confidence intervals for various interacting drugs' effects on ambrisentan. It shows Cmax and AUC values alongside dosing recommendations, indicating no dose adjustments are necessary for listed drugs including cyclosporine, digoxin, ethinylestradiol, norethindrone, mycophenolic acid, ritonavir, sildenafil, desmethylsildenafil, tadalafil, and warfarin.*

FDA Label Image

Figure 4 Mean Change In 6-minute Walk Distance (aries-1 And Aries-2) (Image 04)

Two line charts titled ARIES-1 and ARIES-2 depict mean change from baseline in 6-minute walk distance over 12 weeks. The vertical axis shows meters, ranging approximately -30 to 60, and the horizontal axis shows time points at Baseline, Week 4, Week 8, and Week 12. Lines represent placebo and varying ambrisentan tablet doses (2.5 mg, 5 mg, 10 mg) with error bars indicating mean ± standard error.*

FDA Label Image

Figure 5 Time To Clinical Worsening (aries-1 And Aries-2) (Image 05)

Two Kaplan-Meier survival curve graphs comparing event-free proportions over 12 weeks between ambrisentan tablets and placebo in ARIES-1 and ARIES-2 studies. Both graphs show percentage event-free on the y-axis and time in weeks on the x-axis, with ambrisentan demonstrating higher event-free rates than placebo. Risk tables display numbers of patients at risk by treatment group over time.*

FDA Label Image

Acceptable Birth Control Options (Image 06)

An instructional diagram titled 'Acceptable Birth Control Options' displaying four options for contraception methods. Each option lists different combinations of methods, such as intrauterine devices, hormonal contraceptives, diaphragms with spermicide, male condoms, and other surgical or hormonal options, organized in labeled boxes.*

FDA Label Image

Ambrisentan Tablets 5 mg Bottle Label (Image 07)

Ambrisentan 5 mg film-coated tablets carton label from Mylan Pharmaceuticals Inc. The label highlights the 5 mg strength, oral dosage form, and packaging of 10 tablets. It includes a barcode, storage instructions at 20° to 25°C, and warnings such as not to split or crush tablets and to keep out of children's reach. Manufactured in India, with NDC 0378-4270-97.*

FDA Label Image

Ambrisentan Tablets 10 mg Bottle Label (Image 08)

Ambrisentan 10 mg film-coated tablets label from Mylan Pharmaceuticals Inc. The label shows dosage strength 10 mg, instructions to dispense the medication guide, storage conditions, and warnings not to split or crush tablets. It includes a barcode, NDC 0378-4271-97, and states the product is Rx only and contains 10 tablets. Manufactured in India.*

* 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.