Budesonide And Formoterol Fumarate Dihydrate Aerosol
Product Images NDC 0310-7372

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 0310-7372). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Astrazeneca Pharmaceuticals Lp, 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 illustrated dial gauge displaying numerical values from 0 to 120, with a pointer currently between 20 and 30, and a red section around zero. The dial is likely part of a device or inhaler, showing a usage or dosage indicator.*

FDA Label Image

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

An illustration of a dial gauge displaying a numeric scale from 0 to 120 with colored segments: red from 0 to about 5, yellow from about 5 to 25, and gray from 25 to 120. A pointer is indicating a position just above 80 on the scale.*

FDA Label Image

Figure 1 (Figure1bodytext)

A line graph showing percent change from baseline in pre-dose FEV1 over 12 weeks for five treatment 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. The x-axis represents weeks (0 to 12), and the y-axis shows percent change from baseline FEV1. Sample sizes at each time point are provided. Symbols differentiate treatments as indicated in the legend below the graph.*

FDA Label Image

Figure 2 (Figure2bodytext)

A line graph showing 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 x-axis represents weeks, and the y-axis shows percent change. Budesonide and Formoterol shows the greatest improvement, followed by Budesonide, Formoterol, and Placebo.*

FDA Label Image

Figure 3 (Figure3bodytext)

A line graph showing percent change from baseline in FEV1 over 12 hours post-dose. The x-axis represents time in hours (0 to 12), and the y-axis shows percent change from baseline, ranging from -10 to 25 percent. Five treatment groups are plotted: 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. The graph compares respiratory lung function changes among these groups over time.*

FDA Label Image

Figure 4 (Figure4bodytext)

A line graph showing percent change from baseline in FEV1 over 12 hours for different treatments of Budesonide and Formoterol Fumarate Dihydrate 160/4.5 mcg aerosol compared with placebo. The x-axis represents hours and the y-axis shows percent change in FEV1. The graph includes lines for 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.*

FDA Label Image

Figure 5 (Figure5bodytext)

A line graph depicting the change from baseline in 1-hour post-dose FEV1 (L) over 12 weeks for Budesonide and Formoterol Fumarate Dihydrate 80/4.5 mcg and Budesonide 80 mcg. The graph shows two lines representing patients receiving two inhalations twice daily of each treatment, with FEV1 changes plotted at weeks 0, 1, 2, 4, 8, and 12. Patient numbers at each assessment are listed below the x-axis.*

FDA Label Image

Figure 6 (Figure6bodytext)

A line graph showing percent change from baseline in pre-dose FEV1 over 6 months for Budesonide and Formoterol Fumarate Dihydrate aerosol and comparator treatments. The x-axis represents time in months, and the y-axis shows percent change from baseline. Multiple treatment groups are plotted, including Budesonide and Formoterol Fumarate 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, their combination, and placebo, with corresponding sample sizes listed 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 of treatment for various Budesonide and Formoterol Fumarate Dihydrate inhalation regimens compared to placebo. Five groups are charted with different markers indicating treatments and doses, with a table below showing sample sizes (N) per time point.*

FDA Label Image

Budesonide Structural Formula (Image 01)

Chemical structure diagram showing molecular representations of Budesonide and Formoterol Fumarate Dihydrate, the active ingredients in the product. The image illustrates detailed carbon ring and functional group arrangements typical for these compounds.*

FDA Label Image

Structural Fumarate (Image 02)

Chemical structure diagram of Budesonide and Formoterol Fumarate Dihydrate, showing molecular components and elements in a detailed line structure format.*

FDA Label Image

Figure 1 (Image 03)

Illustration diagram of a Budesonide and Formoterol Fumarate Dihydrate 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)

An instructional diagram showing hands demonstrating the removal of a protective cap from a Budesonide and Formoterol Fumarate Dihydrate inhaler. Arrows indicate the direction to pull or lift the cap away from the inhaler device, preparing it for use.*

FDA Label Image

Figure 3 (Image 05)

Illustration showing a hand holding a red aerosol inhaler with the mouthpiece facing forward and a spray being released from the mouthpiece. The inhaler cap is removed and held below the mouthpiece. The image demonstrates the use of a Budesonide and Formoterol Fumarate Dihydrate respiratory aerosol inhaler.*

FDA Label Image

Figure 4 (Image 06)

An instructional illustration showing hands using a red inhaler device to administer aerosol medication to a finger. The inhaler mouthpiece is open, directing mist onto the fingertip. A protective cap is removed and positioned below the inhaler.*

FDA Label Image

Figure 5 (Image 07)

An instructional illustration showing a person using an aerosol inhaler by placing the inhaler mouthpiece into their mouth and inhaling. The image demonstrates the correct positioning and use of the inhaler device.*

FDA Label Image

Symbicort Ag 80/4.5 Mcg 120 Inhalations Carton (Image 10)

Label for Budesonide and Formoterol Fumarate Dihydrate inhalation aerosol, strength 80 mcg/4.5 mcg per inhalation. The packaging specifies 120 inhalations per container. Manufactured by AstraZeneca Pharmaceuticals LP, the label includes storage instructions to keep the product upright and indicates the product is for oral inhalation only and available by prescription.*

FDA Label Image

Symbicort Ag 160/4.5 Mcg 120 Inhalations Carton (Image 11)

Label for Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol, strength 160/4.5 mcg. The label indicates a respiratory aerosol dosage form with 120 inhalations per container. It is manufactured by AstraZeneca Pharmaceuticals LP and includes instructions to store upright and use for oral inhalation only.*

* 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.