Budesonide And Formoterol Fumarate Dihydrate Aerosol
Product Images NDC 50090-6327

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 50090-6327). 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 showing a circular dial gauge ranging from 0 to 120 with color-coded sections: a red segment at 0, a yellow segment from approximately 5 to 20, and the remainder in white. The dial's pointer indicates slightly above 20. It likely represents a dose counter or usage indicator for an inhalation aerosol device.*

FDA Label Image

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

An illustration depicting a dial or gauge marked with numbers from 0 to 120 in increments of 10, with a red zone near zero and a yellow warning zone around 10 to 20, likely representing a dose counter for an inhaler device.*

FDA Label Image

Figure 1 (Figure1bodytext)

A line graph showing percent change from baseline in predose FEV1 over 12 weeks of treatment. The graph compares five groups: Budesonide and Formoterol Fumarate Dihydrate 160/4.5 mcg inhalations, Budesonide 160 mcg twice daily, Formoterol 4.5 mcg twice daily, Budesonide 160 mcg plus Formoterol 4.5 mcg twice daily, and Placebo. Sample sizes are listed for each group at baseline, weeks 2, 6, and 12, and end of treatment.*

FDA Label Image

Figure 2 (Figure2bodytext)

A line graph showing the percent change from baseline in predose FEV1 over 12 weeks for four treatment groups: Budesonide and Formoterol Fumarate Dihydrate 80/4.5 mcg, Budesonide 80 mcg, Formoterol 4.5 mcg, and placebo. The graph includes a legend and sample sizes (n) for each group at various weeks, illustrating the comparative respiratory effects of each treatment.*

FDA Label Image

Figure 3 (Figure3bodytext)

A line graph showing percent change from baseline in FEV1 over 12 hours for various inhalation treatments, including Budesonide and Formoterol Fumarate Dihydrate 160/4.5 mcg, Budesonide 160 mcg alone, Formoterol 4.5 mcg alone, Budesonide 160 mcg plus Formoterol 4.5 mcg combined, and placebo. The x-axis represents time in hours, while the y-axis indicates percent change in FEV1. The combined formulation and individual components show higher improvements than placebo over the 12-hour period.*

FDA Label Image

Figure 4 (Figure4bodytext)

A line graph showing the percent change from baseline in FEV1 over 12 hours for five different treatments: Budesonide and Formoterol Fumarate Dihydrate 160/4.5 mcg (two inhalations twice daily), Budesonide 160 mcg (two inhalations twice daily), Formoterol 4.5 mcg (two inhalations twice daily), Budesonide 160 mcg plus Formoterol 4.5 mcg (two inhalations twice daily), and placebo. The x-axis represents hours from 0 to 12 and the y-axis shows percent change in FEV1. The graph indicates FEV1 changes post-dose, including day 1 predose and final visit predose values.*

FDA Label Image

Figure 5 (Figure5bodytext)

Line graph showing change from baseline in 1-hour post-dose FEV1 (L) over 12 weeks, comparing Budesonide and Formoterol Fumarate Dihydrate 80/4.5 mcg with Budesonide 80 mcg. The graph includes data points and a legend for both treatments along with the number of patients assessed at each time point.*

FDA Label Image

Figure 6 (Figure6bodytext)

Line graph showing the percent change from baseline in pre-dose FEV1 over a 6-month period and at the end of treatment for different treatments: Budesonide and Formoterol Fumarate Dihydrate MDI 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, combination of Budesonide 160 mcg plus Formoterol 4.5 mcg, and placebo. The x-axis represents time in months, and the y-axis represents percent change in FEV1. Each treatment is represented by distinct symbols and lines with corresponding sample sizes at each time point indicated below the graph.*

FDA Label Image

Figure 7 (Figure7bodytext)

A line graph depicting the percent change from baseline in 1-hour post-dose FEV1 over six months for various treatments including Budesonide and Formoterol Fumarate Dihydrate MDI 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, a combination of Budesonide 160 mcg plus Formoterol 4.5 mcg, and placebo. The x-axis represents months of treatment, and the y-axis shows percent change in FEV1. The graph includes sample sizes for each group at different time points.*

FDA Label Image

Budesonide Structural Formula (Image 01)

Chemical structure diagram showing two molecular structures. The first structure represents the steroid Budesonide, characterized by multiple rings and functional groups including hydroxyl and ketone groups. The second structure represents Formoterol, featuring an ether linkage and an ethyl side chain. This image illustrates the active ingredients of Budesonide and Formoterol Fumarate Dihydrate inhalation aerosol.*

FDA Label Image

Structural Fumarate (Image 02)

Chemical structure diagram of Budesonide and Formoterol Fumarate Dihydrate, showing the molecular components and arrangement, including associated fumarate and water molecules.*

FDA Label Image

Figure 1 (Image 03)

An illustration of a red respiratory inhaler device showing labelled parts including the counter, canister inside, inhaler body, mouthpiece, strap, and mouthpiece cover. The diagram visually identifies each component of the inhaler.*

FDA Label Image

Figure 2 Gray Arrows (Image 04)

Illustration showing a hand removing the protective cap from the mouthpiece of a red aerosol inhaler, indicating steps for preparing Budesonide and Formoterol Fumarate Dihydrate inhalation aerosol for use.*

FDA Label Image

Figure 3 (Image 05)

An instructional illustration showing a hand holding a red aerosol inhaler with a protective cap removed. The inhaler is depicted releasing a spray mist from its nozzle. The image is labeled as Figure 3, demonstrating proper use of the inhaler device.*

FDA Label Image

Figure 4 (Image 06)

An instructional illustration showing a person holding a red and gray aerosol inhaler device. The device is positioned above the left wrist with the cap removed, releasing a spray into the skin. This image likely demonstrates the proper technique for using the inhaler. Figure labeled as 'Figure 4'.*

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Figure 5 (Image 07)

An instructional illustration showing a person using an inhaler aerosol device by placing the mouthpiece in their mouth and pressing the canister to release the medication, demonstrating the proper technique for inhalation.*

FDA Label Image

Label Image (Lbl500906327)

Label for Budesonide and Formoterol Fumarate Dihydrate 160; 4.5 ug/1 aerosol inhalation by A-S Medication Solutions. The label includes storage instructions to keep the product at controlled room temperature 68 to 77 degrees Fahrenheit and states the package contains 120 inhalations. The NDC is 50090-6327-0.*

* 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.