Budesonide And Formoterol Fumarate Dihydrate Aerosol
Product Images NDC 50090-6382

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Budesonide And Formoterol Fumarate Dihydrate (NDC 50090-6382). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by A-s Medication Solutions, 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

Counter Image 15 (308708 Rapihaler Counter 15 (black;130;485))

An illustration of a circular gauge with numerical markings from 0 to 120 in increments of 10. The range from 0 to 20 is highlighted with color segments: red from 0 to 5, yellow from 5 to 20, indicating a scale or meter reading.*

FDA Label Image

Counter Image 80 (308710 Rapihaler Counter 80 (black;130;485))

An illustrated dial or gauge with numeric markings from 0 to 120, including colored segments in red, beige, and grey. The indicator needle points near 80. This appears to be a dose counter or meter used on an inhalation aerosol device.*

FDA Label Image

Figure 1 (Figure1bodytext)

A line graph illustrating percent change from baseline in pre-dose FEV1 over a 12-week treatment period. The graph compares five groups: Budesonide and Formoterol Fumarate Dihydrate 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, Budesonide 160 mcg + Formoterol 4.5 mcg, and placebo, showing data points at weeks 0, 2, 6, and 12 with sample sizes noted for each group at these time points.*

FDA Label Image

Figure 2 (Figure2bodytext)

A line graph showing percent change from baseline in predose FEV1 over a 12-week period. The graph compares four groups: Budesonide and Formoterol Fumarate Dihydrate 80/4.5 mcg (two inhalations twice daily), Budesonide 80 mcg (two inhalations twice daily), Formoterol 4.5 mcg (two inhalations twice daily), and placebo. The Y-axis shows percent change, and the X-axis shows weeks, with data points marked at weeks 0, 2, 6, and 12, including end of treatment values.*

FDA Label Image

Figure 3 (Figure3bodytext)

Line graph showing the percent change from baseline in FEV1 over 12 hours for different treatments, including Budesonide and Formoterol Fumarate Dihydrate 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, a combination of Budesonide 160 mcg + Formoterol 4.5 mcg, and placebo. The x-axis represents time in hours and the y-axis represents percent change in FEV1.*

FDA Label Image

Figure 4 (Figure4bodytext)

A line graph showing the percent change from baseline in FEV1 over 12 hours. The x-axis represents time in hours, and the y-axis shows percent change in FEV1. Multiple lines compare different treatments: Budesonide and Formoterol Fumarate Dihydrate 160/4.5 mcg, Budesonide 160 mcg alone, Formoterol 4.5 mcg alone, a combination of Budesonide 160 mcg and Formoterol 4.5 mcg, and placebo. Data points indicate variations in lung function response over a 12-hour period.*

FDA Label Image

Figure 5 (Figure5bodytext)

A line graph showing change from baseline in 1-hour post-dose FEV1 (L) over 12 weeks for Budesonide and Formoterol Fumarate Dihydrate 80/4.5 mcg versus Budesonide 80 mcg. The graph compares two inhalations twice daily for each treatment, with higher increases in FEV1 observed for the combination therapy throughout the time points.*

FDA Label Image

Figure 6 (Figure6bodytext)

A line graph showing the percent change from baseline in pre-dose FEV1 over six months of treatment. The graph compares five groups: Budesonide and Formoterol Fumarate Dihydrate MDI 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, Budesonide 160 mcg plus Formoterol 4.5 mcg, and placebo. The y-axis measures percent change, and the x-axis measures time in months, including end of treatment data. Each group is represented by a distinct symbol with a sample size (N) listed for each time point below the graph.*

FDA Label Image

Figure 7 (Figure7bodytext)

A line graph showing percent change from baseline in 1-hour post-dose FEV1 over six months and at end of treatment for five groups: Budesonide and Formoterol Fumarate Dihydrate MDI 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, Budesonide 160 mcg + Formoterol 4.5 mcg, and Placebo. The vertical axis shows percent change, and the horizontal axis shows time points at 0, 1, 2, 4, 6 months, and end of treatment. Sample sizes at each time point are indicated below the graph.*

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Budesonide Structural Formula (Image 01)

Chemical structure diagram showing the molecular components of Budesonide and Formoterol Fumarate Dihydrate, the active ingredients in this respiratory aerosol product.*

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Structural Fumarate (Image 02)

Chemical structure diagram of Budesonide and Formoterol Fumarate Dihydrate, showing molecular components and hydration states as indicated by chemical groups and water molecules.*

FDA Label Image

Figure 1 (Image 03)

An instructional illustration of a respiratory aerosol inhaler showing labeled parts including the counter, canister inside, inhaler body, mouthpiece, strap, and mouthpiece cover.*

FDA Label Image

Figure 2 Gray Arrows (Image 04)

Instructional illustration showing correct use of Budesonide and Formoterol Fumarate Dihydrate aerosol inhaler. The image depicts hands pressing the inhaler canister downwards into the mouthpiece to release medication. Arrows indicate the direction of pressing and inhaler parts involved.*

FDA Label Image

Figure 3 (Image 05)

An instructional illustration showing a hand holding a red aerosol inhaler with a gray cap removed. The inhaler is depicted releasing a spray mist from its mouthpiece. The image appears to demonstrate the correct way to hold and use the inhaler.*

FDA Label Image

Figure 4 (Image 06)

Illustration showing hands using a red and gray inhaler device to dispense aerosol medication onto a finger. The image appears to demonstrate how to actuate the inhaler, releasing a spray of medication for respiratory inhalation.*

FDA Label Image

Figure 5 (Image 07)

An instructional illustration showing a person using a red aerosol inhaler. The person holds the inhaler upright with the mouthpiece in their mouth, demonstrating the proper inhalation technique for respiratory medication delivery.*

FDA Label Image

Label Image (Lbl500906382)

Packaging label for Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol, 80/4.5 strength, distributed by A-S Medication Solutions. The label includes NDC 50090-6382-0, package size of 120 inhalations, and storage instructions to keep between 68 to 77 degrees F. The package caution states it contains one canister with a net fill weight of 10.26 grams and requires reading the package insert for dosing.*

* 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.