Umeclidinium And Vilanterol Ellipta Powder
Product Images NDC 66993-134

Product Visual Gallery

This gallery contains 23 technical images submitted to the FDA as part of the official labeling for Umeclidinium And Vilanterol Ellipta (NDC 66993-134). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Prasco Laboratories, 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

Umeclidinium Bromide Chemical Structure (Umeclidinium Vilanterol Ellipta Spl Graphic 01)

Chemical structure diagram of umeclidinium bromide, the active ingredient in Umeclidinium and Vilanterol Ellipta. The diagram shows molecular bonds and ring structures characteristic of umeclidinium bromide.*

FDA Label Image

Vilanterol Trifenatate Chemical Structure (Umeclidinium Vilanterol Ellipta Spl Graphic 02)

Chemical structure of umeclidinium bromide and vilanterol trifenatate, the active ingredients in Umeclidinium and Vilanterol Ellipta inhalation powder. The diagram shows molecular bonds, including aromatic rings, hydroxyl groups, and chlorine atoms relevant to the molecules.*

FDA Label Image

Figure 1 (Umeclidinium Vilanterol Ellipta Spl Graphic 03)

A pharmacokinetic chart depicting fold change and 90% confidence intervals for umeclidinium (UMEC) and vilanterol (VI) in various populations, including by gender, age over 65, severe renal impairment, moderate hepatic impairment, and CYP2D6 poor metabolizers. The horizontal axis shows change relative to reference. Recommendations indicate no dose adjustments for all groups.*

FDA Label Image

Figure 2 (Umeclidinium Vilanterol Ellipta Spl Graphic 04)

A chart showing the pharmacokinetic fold change and 90% confidence intervals for umeclidinium (UMEC) and vilanterol (VI) with interacting drugs verapamil and ketoconazole. The graph plots change relative to reference for AUC and Cmax parameters, accompanied by dosing recommendations such as 'No dose adjustment' for verapamil and 'Caution' for ketoconazole.*

FDA Label Image

Figure 3 (Umeclidinium Vilanterol Ellipta Spl Graphic 05)

A line graph showing the least squares mean change from baseline in milliliters (mL) over time (hours) for different doses of Umeclidinium (15.6 mcg, 31.25 mcg, 62.5 mcg, 125 mcg) compared to placebo. The x-axis represents time in hours, and the y-axis represents the change in mL from baseline. Each dose is represented by a different symbol and line, indicating the effect of each dosage over a 6-hour period.*

FDA Label Image

Figure 3 (Umeclidinium Vilanterol Ellipta Spl Graphic 06)

A line graph showing least squares mean change from baseline in mL over a 24-hour period for different doses of umeclidinium (15.6 mcg, 31.25 mcg, 62.5 mcg, 125 mcg) and placebo. The x-axis represents time in hours, and the y-axis shows change in mL, with multiple lines depicting varying dose responses over time.*

FDA Label Image

Figure 4 (Umeclidinium Vilanterol Ellipta Spl Graphic 07)

A line chart depicting the least squares mean change from baseline in lung function measured in mL over time (hours) for various doses of vilanterol compared to placebo. Different symbols represent placebo and vilanterol at 3.0, 6.25, 12.5, 25, and 50 mcg doses, showing the time course of lung function changes up to 24 hours post-dose.*

FDA Label Image

Figure 4 (Umeclidinium Vilanterol Ellipta Spl Graphic 08)

A line graph showing the least squares mean change from baseline in milliliters over a 24-hour period for different doses of Vilanterol compared to a placebo. The x-axis represents time in hours, and the y-axis represents the change in milliliters. Multiple dose levels of Vilanterol (3.0 mcg, 6.25 mcg, 12.5 mcg, 25 mcg, 50 mcg) and placebo are plotted with distinct markers.*

FDA Label Image

Figure 5 (Umeclidinium Vilanterol Ellipta Spl Graphic 09)

Line chart showing the least squares mean change from baseline in mL over 24 hours for different treatments including placebo, umeclidinium 62.5 mcg, vilanterol 25 mcg, and the combination of umeclidinium 62.5 mcg/vilanterol 25 mcg. The x-axis represents time in hours, and the y-axis represents the change in mL from baseline.*

FDA Label Image

Figure 5 (Umeclidinium Vilanterol Ellipta Spl Graphic 10)

A line graph illustrating the least squares mean change from baseline in milliliters (mL) over time (hours) for placebo, umeclidinium 62.5 mcg, vilanterol 25 mcg, and a combination of umeclidinium 62.5 mcg with vilanterol 25 mcg. The graph shows changes measured at multiple time points from 0 to 24 hours post-dose, with each treatment group represented by distinct symbols on the plotted lines.*

FDA Label Image

Umeclidinium And Vilanterol Ellipta Inhaler Parts (Umeclidinium Vilanterol Ellipta Spl Graphic 11)

An instructional diagram illustrating the contents of the Umeclidinium and Vilanterol Ellipta inhalation powder packaging. It shows the carton, tray, tray lid, inhaler device, desiccant packet, and patient information leaflet clearly labeled and separated to depict packaging components.*

FDA Label Image

Figure A (Umeclidinium Vilanterol Ellipta Spl Graphic 12)

An instructional illustration showing a hand peeling back the foil lid from a blister tray containing multiple capsules or tablets, likely related to the packaging or usage of a respiratory inhalation powder product.*

FDA Label Image

Figure B (Umeclidinium Vilanterol Ellipta Spl Graphic 13)

An instructional illustration depicting the disposal of a medication pouch into a trash can. The image shows a hand holding a small packet above an open trash bin with a lid set aside, indicating proper disposal of unused medication packaging.*

FDA Label Image

Figure C (Umeclidinium Vilanterol Ellipta Spl Graphic 14)

An instructional diagram showing a handheld inhaler device with a labeled cover and a visible dose counter displaying the number 30. The illustration is likely to assist users in identifying parts of the inhaler used for administering respiratory powder medication.*

FDA Label Image

Figure D (Umeclidinium Vilanterol Ellipta Spl Graphic 15)

An instructional diagram showing how to open the mouthpiece cover of an inhaler device. It includes labeled parts such as the mouthpiece, counter displaying the number 29, air vent, and the cover. The diagram indicates a "click" sound when the cover is opened by rotating it downwards.*

FDA Label Image

Figure E (Umeclidinium Vilanterol Ellipta Spl Graphic 16)

An instructional illustration showing a person using a respiratory inhalation device. The person is holding the inhaler near their mouth and exhaling, indicated by arrows pointing outward from the mouth, demonstrating the correct inhalation technique for powder medication administration.*

FDA Label Image

Figure F (Umeclidinium Vilanterol Ellipta Spl Graphic 17)

Illustration showing a person using a respiratory inhalation device by placing it near their nose, presumably to demonstrate the proper technique for inhaling the powdered medication.*

FDA Label Image

Figure G (Umeclidinium Vilanterol Ellipta Spl Graphic 18)

An instructional diagram showing a hand holding a respiratory inhalation device, with fingers positioned to avoid blocking the air vent, as indicated by the caution text above the image.*

FDA Label Image

Figure H (Umeclidinium Vilanterol Ellipta Spl Graphic 19)

An instructional illustration showing a person inhaling with a timer icon indicating to hold the breath for 3-4 seconds. The image focuses on the lower face and upper torso, demonstrating a step in the inhalation process.*

FDA Label Image

Figure I (Umeclidinium Vilanterol Ellipta Spl Graphic 20)

An instructional illustration showing a person holding a round inhaler device near their mouth and exhaling or breathing out away from the inhaler. Arrows indicate the direction of breath away from the mouthpiece before inhalation.*

FDA Label Image

Figure J (Umeclidinium Vilanterol Ellipta Spl Graphic 21)

An instructional illustration showing a dry powder inhaler device with a ridged mouthpiece cover being opened by lifting it upwards. The inhaler displays the number 29 on a small tally window, likely indicating the remaining doses.*

FDA Label Image

Figure K (Umeclidinium Vilanterol Ellipta Spl Graphic 22)

An instructional diagram illustrating the inhaler device with emphasis on a red indicator displaying the number '9', likely showing dose count or device status. The image highlights the red indicator area on the inhaler with an arrow and label.*

FDA Label Image

Umeclidinium And Vilanterol Ellipta 30 Dose Carton (Umeclidinium Vilanterol Ellipta Spl Graphic 23)

Umeclidinium and Vilanterol ELLIPTA Inhalation Powder, 62.5 mcg/25 mcg, by Prasco Laboratories. The label shows a cartridge-shaped inhaler device with a dose counter displaying 30 doses. The packaging indicates the product is for oral inhalation only, containing two blister strips with umeclidinium bromide and vilanterol trifenatate powders. The product has a total of 60 blisters (30 doses per strip).*

* 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.