Budesonide And Formoterol Fumarate Dihydrate Aerosol
Product Images NDC 85766-113

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Budesonide And Formoterol Fumarate Dihydrate (NDC 85766-113). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sportpharm 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.

FDA Label Image

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

An illustration of a dose counter dial for an inhaler, displaying numbers from 0 to 120 in increments of 10. The dial shows 19 doses left, with color-coded segments: red near zero, yellow-orange from 10 to 20, and white thereafter.*

FDA Label Image

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

An illustration of a circular dose counter dial for an inhalation aerosol device. The dial is marked in increments from 0 to 120, with a red zone near zero indicating low doses remaining, an orange section from approximately 10 to 20, and a gray area from 20 to 120. An arrow indicator points to about 80, signifying the approximate number of doses left.*

FDA Label Image

Figure 1 (Figure1bodytext)

A line graph depicting the percent change from baseline in pre-dose FEV1 over 12 weeks for five groups: Budesonide and Formoterol Fumarate Dihydrate 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, Budesonide 160 mcg plus Formoterol 4.5 mcg, and placebo. Each group is represented with different symbols and the graph includes participant counts at each time point and at the end of treatment.*

FDA Label Image

Figure 2 (Figure2bodytext)

A line graph depicting percent change from baseline in predose FEV1 over 12 weeks for four groups: Budesonide and Formoterol Fumarate Dihydrate 80/4.5 mcg, Budesonide 80 mcg, Formoterol 4.5 mcg, and Placebo. The x-axis represents time in weeks, and the y-axis shows percent change, with corresponding sample sizes listed below the graph.*

FDA Label Image

Figure 3 (Figure3bodytext)

Line graph showing percent change from baseline in FEV1 over 12 hours for different treatments including Budesonide and Formoterol Fumarate Dihydrate (160/4.5 mcg), Budesonide alone (160 mcg), Formoterol alone (4.5 mcg), the combination of Budesonide 160 mcg and Formoterol 4.5 mcg, and placebo. The x-axis shows time in hours (0 to 12), and the y-axis shows percent change from baseline. The graph compares lung function response over time among these treatment groups.*

FDA Label Image

Figure 4 (Figure4bodytext)

A line graph showing percent change from baseline in FEV1 over 12 hours for treatments including Budesonide and Formoterol Fumarate Dihydrate 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, Budesonide 160 mcg plus Formoterol 4.5 mcg, and placebo. The x-axis represents hours and the y-axis percent change in FEV1. Different markers represent each treatment group's FEV1 response over time.*

FDA Label Image

Figure 5 (Figure5bodytext)

A line graph showing the change from baseline in 1-hour post-dose FEV1 (L) over a 12-week period for two treatments: Budesonide and Formoterol Fumarate Dihydrate 80/4.5 mcg (two inhalations twice daily) and Budesonide 80 mcg (two inhalations twice daily). The graph plots FEV1 changes on the y-axis and weeks on the x-axis, with data points for baseline, 1 hour, 2, 4, 8, and 12 weeks. Budesonide and Formoterol combination shows higher FEV1 increases throughout the study compared to Budesonide alone.*

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 Budesonide and Formoterol Fumarate Dihydrate MDI 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, a combination of Budesonide 160 mcg and Formoterol 4.5 mcg, and placebo, each administered as two inhalations twice daily. Patient sample sizes (N) at each time point are included below the graph.*

FDA Label Image

Figure 7 (Figure7bodytext)

A line graph showing the percent change from baseline in 1-hour post-dose FEV1 over six months and at the end 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. Sample sizes (N) for each group at different time points are listed below the graph.*

FDA Label Image

Budesonide Structural Formula (Image 01)

Chemical structure of the active ingredients in Budesonide and Formoterol Fumarate Dihydrate combination aerosol, showing detailed molecular diagrams for Budesonide and Formoterol components.*

FDA Label Image

Structural Fumarate (Image 02)

Chemical structure of the active ingredient Budesonide and Formoterol Fumarate Dihydrate, showing its molecular components including formoterol, budesonide moiety, fumarate, and hydration elements.*

FDA Label Image

Figure 1 (Image 03)

An instructional illustration of a respiratory inhaler device showing labeled parts including the counter, inhaler body, canister inside, mouthpiece, strap, and mouthpiece cover. This diagram helps identify the components of the Budesonide and Formoterol Fumarate Dihydrate aerosol inhaler.*

FDA Label Image

Figure 2 Gray Arrows (Image 04)

Illustration showing the use of a Budesonide and Formoterol Fumarate Dihydrate aerosol inhaler. The diagram depicts a hand pressing down on the red inhaler canister inside a gray actuator, demonstrating the inhaler actuation process for respiratory administration.*

FDA Label Image

Figure 3 (Image 05)

Illustration showing proper use of Budesonide and Formoterol Fumarate Dihydrate aerosol inhaler. A hand is holding the inhaler, pressing down to release the aerosol spray, with the cap removed and shown below the device. The image depicts the correct inhalation technique for respiratory administration.*

FDA Label Image

Figure 4 (Image 06)

Illustration demonstrating the use of an inhaler device. It shows hands holding the inhaler with the mouthpiece open and a dose being released onto a finger, indicating priming or checking the spray before use.*

FDA Label Image

Figure 5 (Image 07)

An instructional illustration showing a person using an aerosol inhaler, demonstrating proper placement of the mouthpiece at the lips for inhalation. The inhaler is held upright with the protective cap removed and attached to the device.*

FDA Label Image

16 (Label 16)

Label for Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 160/4.5, containing 120 inhalations. Manufactured for AstraZeneca Pharmaceuticals LP by Enovachem Pharmaceuticals Torrance, CA. Includes National Drug Code (NDC) 85766-114-12 and instructions against refilling without a prescription. Displays lot and expiration placeholders, and storage instructions.*

FDA Label Image

80 (Label 80)

Label for Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 micrograms, packaged in a quantity of 120 inhalations. The product is relabeled for SportPharm and manufactured for AstraZeneca Pharmaceuticals LP. The label includes lot, batch, and expiration data fields, along with a QR code and regulatory 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.