Ambrisentan Tablet, Film Coated
Product Images NDC 42794-052

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Ambrisentan (NDC 42794-052). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sigmapharm Laboratories, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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10mg1 (10mg1)

NDC 42794-0! 52-08 is a medication called Ambrisentan Tablets that comes in bottles containing 30 Tablets. Each tablet contains 10 mg of ambrisentan. Patients must not split, crush or chew the tablet. The tablets should be stored at a temperature of 25°C (77°F), but may be stored anywhere between 15-30°C (59-86°F). The container should be tightly closed, and the medication is to be dispensed only in its original container. Sigmapharm Laboratories, LLC manufactures this medication, and the package insert should be reviewed to determine the correct dosage and method of administration.*

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5mg1 (5mg1)

This is a description of Ambrisentan Tablets with NDC 42794-051-08. Each tablet contains 5 mg of Ambrisentan. The tablets should not be split, crushed, or chewed. They should be stored at a temperature of 25°C (77°F) with excursions permitted to 15-30°C (59-86°F) as per USP. Sigmapharm Laboratories, LLC is the dispenser of this medication. Each container has an attached medication guide for patients. The container must be kept tightly closed, and the medication should be dispensed only in its original container. Dosage and administration information can be found in the package insert.*

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Figure1 (Figure1)

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Figure2 (Figure2)

This appears to be a list of drugs and related recommendations. The drugs include Cyclosporine, Mycophenalate Mofetl, Ketoconazole, Rifampin, Sildenafil, Tadalafil, Warfarin and Ambrisentan. There are no significant changes recommended for the doses of the drugs listed, except for Ambrisentan which is recommended to be limited to 5mg once daily.*

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Figure3 (Figure3)

This appears to be a table of drugs that may interact with each other. Cyclosporine, Digosin, Ethinylestradiol, and Norethindeone are listed as "interacting drugs", while Ritonavir, Tadalafil, Warfarin, $-Warfarin, RWarfurin, and K are listed as other drugs. The table mentions "fold change" and a recommendation of "no dose adjustment" for each drug combination. The numbers at the bottom of the table appear to indicate the percentage of change relative to the interacting drug alone. The context in which this table was found may provide additional information about the significance of these drug interactions.*

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Figure4 (Figure4)

This appears to be a chart showing the results of a clinical trial testing a drug called "Placebo" in two groups, ARIES-1 and ARIES-2. The doses given were either 5mg or 10mg (for ARIES-1) and 5mg or 25mg (for ARIES-2). The chart shows the results at baseline and at weeks 4, 8, and 12. There is no information about what condition or disease the drug was meant to treat.*

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Figure5 (Figure5)

This text contains data related to a clinical trial of a drug named "Ambrisentan" and a placebo. The data represents the results of two trials named "ARIES" and "ARIES 2". Both trials had different dosages and durations. Therefore, this text may be used by medical professionals to study the effect of Ambrisentan on patients over time.*

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Figure6 (Figure6)

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Figure7 (Figure7)

This is a statistical table showing Hazard Ratios with a 95% confidence interval for primary endpoint events and inadequate long term clinical response. The comparison is made for different treatments such as Combination vs. Ambrisentan Monotherapy and Combination vs. Tadalafil Monotherapy. There are also P values mentioned. No additional information about the study or treatment is available.*

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Figure8 (Figure8)

This appears to be a table or a chart with hazard ratios and corresponding confidence intervals and events for various subgroups in a study related to the effectiveness of different types of treatments for pulmonary arterial hypertension. However, the information cannot be fully deciphered as the context and headings are unavailable.*

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Figure9 (Figure9)

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Mg1 (Mg1)

This text appears to be a list of different contraceptive methods including intrauterine devices, hormonal implants, injections, condoms, diaphragms, cervical caps, and hormonal contraceptives like the pill or patch.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.