Ambrisentan Tablet, Film Coated
Product Images NDC 47335-236

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Ambrisentan (NDC 47335-236). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sun Pharmaceutical Industries, 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

Spl-10mg-label (Spl 10mg Label)

Label for Ambrisentan Tablets 10 mg by Sun Pharmaceutical Industries, Inc. The label includes the NDC 47335-237-83 and states the quantity as 30 tablets. It instructs pharmacists to dispense with a Medication Guide provided separately to patients. The label also features a barcode and a note to open for full labeling.*

FDA Label Image

Spl-5mg-label (Spl 5mg Label)

Label for ambrisentan tablets 5 mg film-coated oral tablets by Sun Pharmaceutical Industries, Inc. The label includes the NDC 47335-236-83, a barcode, and states 'Rx only' with a quantity of 30 tablets. It instructs pharmacists to dispense with a Medication Guide provided separately.*

FDA Label Image

Spl-ambrisentan-showbox-10mg (Spl Ambrisentan Showbox 10mg)

Label for Ambrisentan Tablets 10 mg, film-coated oral tablets by Sun Pharmaceutical Industries, Inc. The package contains 10 tablets (1 unit-dose strip of 10). The label includes storage instructions, dosage caution, and manufacturer and distributor details. The Sun Pharma logo is visible on the label.*

FDA Label Image

Spl-ambrisentan-showbox-5mg (Spl Ambrisentan Showbox 5mg)

Label for Ambrisentan Tablets 5 mg film-coated tablets by Sun Pharmaceutical Industries, Inc. The label indicates a prescription-only product with a package size of 10 tablets (1 x 10 unit-dose). Storage instructions, warnings, and manufacturer/distributor details are included.*

FDA Label Image

Spl-figure2 (Spl Figure2)

A chart showing the effects of various interacting drugs on the pharmacokinetics of ambrisentan. The x-axis represents fold change relative to ambrisentan alone, displaying Cmax and AUC values with 90% confidence intervals for each drug. Recommendations on dose adjustments are listed, mostly indicating no dose adjustment, except for cyclosporine recommending limiting ambrisentan to 5 mg once daily.*

FDA Label Image

Spl-figure3 (Spl Figure3)

A chart titled 'Effects of Ambrisentan on Other Drugs' showing the fold change and 90% confidence intervals for pharmacokinetic parameters (Cmax, AUC, and others) of various interacting drugs relative to the drugs alone. The drugs listed include Cyclosporine, Digoxin, Ethinylestradiol, Norethindrone, Mycophenolic acid, Ritonavir, Sildenafil, Desmethylsildenafil, Tadalafil, and Warfarin (including S-Warfarin and R-Warfarin). The x-axis represents the change relative to the interacting drug alone, ranging from 0.0 to 3.0 fold. The recommendation for all drugs is stated as 'No dose adjustment.' Additional notes indicate Mycophenolic acid is an active metabolite and GMR (95% CI) for INR is provided for Warfarin.*

FDA Label Image

Spl-figure4 (Spl Figure4)

A figure showing two line graphs titled 'Mean Change in 6-Minute Walk Distance (ARIES-1 and ARIES-2)'. Each graph plots distance in meters on the y-axis against time points Baseline, Week 4, Week 8, and Week 12. The ARIES-1 graph compares placebo, 5 mg, and 10 mg dosages, while the ARIES-2 graph compares placebo, 2.5 mg, and 5 mg dosages of ambrisentan. Data points include error bars for each measurement.*

FDA Label Image

Spl-figure5 (Spl Figure5)

Line graphs titled 'Time to Clinical Worsening (ARIES-1 and ARIES-2)' showing event-free percentages over 12 weeks, comparing Ambrisentan and Placebo groups. The first graph (ARIES-1) and second graph (ARIES-2) indicate higher event-free percentages for Ambrisentan versus Placebo. Both graphs include numbers at risk over time and p-values of 0.030 and 0.005, respectively.*

FDA Label Image

Spl-structure (Spl Structure)

Chemical structure of ambrisentan, showing the molecular arrangement with a carboxylic acid group, two methyl-substituted nitrogens in a pyrimidine ring, and additional aromatic rings with methoxy and phenyl groups.*

* 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.