Ambrisentan Tablet, Film Coated
Product Images NDC 59651-495

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Ambrisentan (NDC 59651-495). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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-fig1.jpg (Ambrisentan Fig1)

A figure showing the drug interaction effects on ambrisentan's pharmacokinetics. It plots fold change and 90% confidence intervals for Cmax and AUC values of ambrisentan when co-administered with various interacting drugs like cyclosporine, mycophenolate mofetil, ketoconazole, omeprazole, rifampin, ritonavir, sildenafil, tacrolimus, tadalafil, and warfarin. Recommendations on dose adjustments are included; most indicate no dose adjustment except cyclosporine, which suggests limiting ambrisentan to 5 mg once daily.*

FDA Label Image

Ambrisentan-fig2.jpg (Ambrisentan Fig2)

A chart displaying fold changes and 90% confidence intervals of pharmacokinetic parameters (Cmax, AUC, Emax, AUEC) for various interacting drugs with ambrisentan. The drugs listed include Cyclosporine, Digoxin, Ethinylestradiol, Norethindrone, Mycophenolic acid, Ritonavir, Sildenafil and its metabolite Desmethylsildenafil, Tadalafil, and Warfarin with subtypes S-Warfarin and R-Warfarin. The x-axis shows change relative to the interacting drug alone, and the recommendation column indicates no dose adjustment needed for all interactions shown.*

FDA Label Image

Ambrisentan-fig3.jpg (Ambrisentan Fig3)

Two line graphs labeled ARIES-1 and ARIES-2 showing distance in meters over time (Baseline, Week 4, Week 8, Week 12). Each graph compares Placebo with varying doses of ambrisentan tablets (5 mg, 10 mg in ARIES-1; 2.5 mg, 5 mg in ARIES-2). Error bars indicate variability around mean values.*

FDA Label Image

Ambrisentan-fig4.jpg (Ambrisentan Fig4)

Two Kaplan-Meier survival curves labeled ARIES-1 and ARIES-2, comparing event-free percentages over 12 weeks between Ambrisentan and placebo groups. The curves show higher event-free rates for Ambrisentan, with participant numbers at risk provided at intervals. Statistical significance values (p=0.030 and p=0.005) are noted for the comparisons.*

FDA Label Image

Figure 6 (Ambrisentan Fig5)

An illustration showing four contraceptive method options. Each option lists recommended methods or combinations, including intrauterine devices, hormonal contraceptives such as estrogen and progesterone oral contraceptives or rings, diaphragms with spermicide, cervical caps with spermicide, male condoms, tubal sterilization, progesterone injections, implants, and partner's vasectomy. The diagram organizes these options in four side-by-side columns labeled Option 1 through Option 4.*

FDA Label Image

Package Label-principal Display Panel (5 mg Container Label (30 Tablets Bottle))

Ambrisentan Tablets 5 mg film-coated oral tablets label. The label includes storage instructions, dosage caution, and pharmacist dispensing information. It also displays the NDC (59651-494-30), package count of 30 tablets, manufacturer Aurobindo Pharma USA, Inc., and a barcode on the right side.*

FDA Label Image

Package Label-principal Display Panel (10 mg Container Label (30 Tablets Bottle))

Label for Ambrisentan Tablets 10 mg, film-coated oral tablets, distributed by Aurobindo Pharma USA, Inc. The container holds 30 tablets. The label includes storage instructions, dosage guidance, and states the product is made in India. The NDC is 59651-495-30.*

FDA Label Image

Ambrisentan-str.jpg (Ambrisentan Str)

Chemical structure diagram of ambrisentan, depicting its molecular arrangement with aromatic rings, methoxy group, carboxylic acid (COOH), and a pyrazine ring with methyl substitutions.*

* 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.