Ambrisentan Tablet, Film Coated
Product Images NDC 69097-387

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.

FDA Label Image

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FDA Label Image

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This is a table that lists various drugs and their interactions with Ambrisentan. It includes information on recommended dose adjustments and fold changes.*

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This appears to be a table of recommendations for dose adjustment of various drugs when taken in combination with other drugs. The table includes information on k fold change and 90% confidence intervals for drugs such as Cyclosporine, Digoxin, Ethinylestradiol, Norethindrone, Mycophenolic acid, Ritonavir, Sildenafil, Desmethylsildenafil, Tadalafil, and R-Warfarin. The data seems to suggest whether dose adjustments are necessary and safe when taking these drugs in combination. At the bottom of the table, there is a graph showing relative changes compared to the interacting drug alone.*

FDA Label Image

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The text describes two studies named ARIES1 and ARIES2, which evaluate the effects of a medication (possibly a placebo) in 5mg and 10mg doses over a 12-week period. The results are depicted in two charts that show the patient's progress from baseline to week 4, 8, and 12. However, without additional context or information, it is not possible to provide a more specific description.*

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ARIES is likely a chart or graph displaying some sort of data over time, possibly related to medical treatment or drug efficacy as it includes mentions of "Ambrisentan" and "Placebo." Without more context or a clear image of the chart, it is difficult to determine the exact meaning of the percentages and data points.*

FDA Label Image

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This appears to be a description of a medication product named Ambrisentan, tablets containing 5 mg each. The package contains 10 tablets and will have information including batch details, expiration date, and serial numbers for commercial packaging. Additionally, the package contains a copy of the medication guide and is for authorized dispensers only. There are several numbers/ID codes mentioned, including NDC 69097-386-19 and NDC 69057-386-19. There is also a mention of "Cipla" and "Ambrisentan Brony Tablets," but it is unclear how they are related to the primary product.*

FDA Label Image

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This is a drug with the NDC code 69067-387-02 that should only be taken using one whole tablet as it contains 10 mg of ambrisentan. The tablets should not be split, chewed, or crushed. The drug should be stored at 25°C (77°F) and the container tightly closed. Dosage and administration details can be found in the package insert. It is manufactured by Cipla Ltd. in India and distributed by Cipla USA, Inc. in Warren, NJ. The medication guide should be given to the patient each time the drug is dispensed. Batch overprinting is available in the packaging area.*

FDA Label Image

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This appears to be a product label for Ambrisentan Tablets, containing 10mg of the medicine. It also includes information on NDC and Rx codes, dosage, and batch information for commercial packing and overprinting. There is also a note to the authorized dispenser to provide a copy of the medication guide to each patient. The remainder of the text seems to be a random collection of characters and numbers that do not provide any additional useful 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.