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Chemical structure diagram of Ambrisentan, showing the arrangement of atoms and bonds within the molecule.*
Ambrisentan Tablet, Film Coated
Product Images NDC 69097-387
10 FDA label images from Cipla Usa Inc. · Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Ambrisentan (NDC 69097-387). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Cipla 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.
Product Images & Figures Index
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A forest plot chart showing the fold change with 90% confidence intervals of Cmax and AUC pharmacokinetic parameters for ambrisentan when coadministered with various interacting drugs. It includes recommendations for dose adjustment, highlighting that cyclosporine requires limiting ambrisentan to 5 mg once daily, while no dose adjustment is needed for other drugs listed, such as mycophenolate mofetil, ketoconazole, and sildenafil.*
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A chart presenting fold changes with 90% confidence intervals for pharmacokinetic parameters (Cmax, AUC, Emax, AUEC) of various interacting drugs when combined with Ambrisentan. The x-axis measures change relative to the interacting drug alone, centralized at 1. Each interacting drug is listed with corresponding recommendations, all indicating no dose adjustment needed.*
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Two line graphs titled ARIES-1 and ARIES-2 depict changes in distance measured in meters on the vertical axis over time points Baseline, Week 4, Week 8, and Week 12 on the horizontal axis. Each graph compares placebo and varying dosages of Ambrisentan tablets (5 mg and 10 mg in ARIES-1; 2.5 mg and 5 mg in ARIES-2). Data markers show trends for each group with error bars at each time point.*
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Two Kaplan-Meier curves from ARIES-1 and ARIES-2 studies showing event-free survival percentages over 12 weeks for Ambrisentan versus placebo. Each graph plots event-free percentage on the y-axis against time in weeks on the x-axis, with higher event-free rates for Ambrisentan compared to placebo. Numbers at risk for both groups are noted below each graph.*
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A flowchart-style data table showing contraception options grouped into four choices. Each option lists recommended birth control methods, including intrauterine devices, hormonal contraceptives like oral pills and patches, barrier methods such as diaphragms and condoms, and sterilization procedures. The table suggests combining methods for effective contraception.*
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Ambrisentan Tablets 5 mg label for oral film-coated tablets, dispensed in a package of 30 tablets. The label states the active ingredient strength as 5 mg per tablet and includes storage instructions at 25°C (77°F). Manufactured by Cipla Ltd., India, and labeled for Cipla USA, Inc. The label includes a barcode and space for batch overprinting with serial number, expiry, and lot information.*
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Packaging label for Ambrisentan Tablets 5 mg by Cipla USA Inc. The label indicates the product contains 10 film-coated tablets per carton. It includes instructions for dispensers to provide a medication guide, the National Drug Code (NDC 69097-386-19), and notes the product is Rx only. The label features barcodes and a space for batch overprinting with GTIN, serial number, expiration date, and lot number.*
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Label for Ambrisentan 10 mg film-coated tablets by Cipla USA Inc. The label states the product is prescription only and contains 30 tablets. Instructions include not to split, crush, or chew. It notes storage at 25°C and dispensing in original containers. Manufactured by Cipla Ltd., India, and marketed by Cipla USA Inc. Serialization, expiry, and lot details are to be overprinted during packing.*
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Packaging label for Ambrisentan 10 mg film-coated tablets by Cipla USA Inc. The label indicates 10 tablets per carton and specifies the active ingredient as 10 mg of ambrisentan per tablet. It includes the NDC 69097-387-19, Rx only designation, barcode, and space for batch overprinting with GTIN, serial number, expiry, and lot information.*
* 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.
