Budesonide And Formoterol Fumarate Dihydrate
Product Images NDC 53002-2666

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 53002-2666). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rpk Pharmaceuticals, Inc., 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 dose counter dial with numbers ranging from 0 to 120 in increments of 10. The dial features color-coded sections: red for 0, orange for 1 to 10, and gray for 20 to 120, indicating the remaining doses, commonly found on inhalers like Budesonide and Formoterol Fumarate Dihydrate inhalation devices.*

FDA Label Image

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

An illustration of a circular gauge or dial with numerical markings from 0 to 120. The dial includes color-coded zones: red from 0 to about 5, orange from about 5 to 20, and white from 20 upwards. The needle points near 80 on the scale. The dial lacks any text or branding related to a pharmaceutical product.*

FDA Label Image

Figure 1 (Figure1bodytext)

A line graph showing percent change from baseline in pre-dose FEV1 over 12 weeks for different treatments including Budesonide and Formoterol Fumarate Dihydrate 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, their combination, and placebo. The graph includes data points at weeks 0, 2, 6, 12, and end of treatment, with each treatment represented by a distinct marker.*

FDA Label Image

Figure 2 (Figure2bodytext)

Line graph depicting percent change from baseline in predose FEV1 over 12 weeks for Budesonide and Formoterol Fumarate Dihydrate 80/4.5 mcg, Budesonide 80 mcg, Formoterol 4.5 mcg, and placebo. The x-axis represents weeks of treatment; the y-axis shows percent change in FEV1. Data points compare treatments, with a legend indicating two inhalations twice daily for active treatments and placebo.*

FDA Label Image

Figure 3 (Figure3bodytext)

A line graph showing the percent change from baseline in FEV1 over 12 hours for five treatments: 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 hours from 0 to 12, and the y-axis shows percent change from baseline in FEV1, ranging from -10 to 25. Data points indicate changes over time for each treatment.*

FDA Label Image

Figure 4 (Figure4bodytext)

A line graph showing the percent change from baseline in FEV1 over 12 hours for various treatment 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. The x-axis represents hours from 0 to 12, and the y-axis represents percent change from baseline in FEV1. Data points illustrate the response over time for each treatment.*

FDA Label Image

Figure 5 (Figure5bodytext)

A line graph comparing the 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 shows separate plotted lines for each treatment group, with data points at multiple time intervals. Patient numbers at each assessment week are listed below the x-axis.*

FDA Label Image

Figure 6 (Figure6bodytext)

A line graph showing the percent change from baseline in pre-dose FEV1 over 6 months for various treatments including Budesonide and Formoterol Fumarate Dihydrate MDI 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, their combination, and placebo. The graph includes a legend, sample sizes (N) at each month, and data points represented by different shapes for each treatment.*

FDA Label Image

Figure 7 (Figure7bodytext)

A line graph showing percent change from baseline in 1-hour post-dose FEV1 over a 6-month period and at the end of treatment for five groups: Budesonide and Formoterol Fumarate Dihydrate MDI 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 months and end of treatment, and the y-axis represents percent change from baseline FEV1.*

FDA Label Image

Budesonide Structural Formula (Image 01)

Chemical structure diagram showing the molecular structures of Budesonide and Formoterol Fumarate Dihydrate, the active ingredients in the product by RPK Pharmaceuticals, Inc.*

FDA Label Image

Structural Fumarate (Image 02)

Chemical structure of formoterol fumarate dihydrate, an active ingredient in Budesonide and Formoterol Fumarate Dihydrate. The diagram shows molecular components including phenyl rings, hydroxyl groups, and fumarate with water molecules as part of the compound's hydration.*

FDA Label Image

Figure 1 (Image 03)

An instructional diagram of an inhaler device, labeled with parts including the counter, canister inside, inhaler body, mouthpiece, strap, and mouthpiece cover. The illustration is a simplified line drawing showing each component clearly for user reference.*

FDA Label Image

Figure 2 Gray Arrows (Image 04)

Instructional illustration showing a hand removing the protective cap from a red inhaler device. Arrows indicate the direction to pull the cap away from the mouthpiece, demonstrating how to prepare the inhaler for use.*

FDA Label Image

Figure 3 (Image 05)

Illustration showing a hand holding an inhaler labeled as Budesonide and Formoterol Fumarate Dihydrate, with the cap removed and medication being released from the mouthpiece. The diagram demonstrates usage by pressing down on the inhaler.*

FDA Label Image

Figure 4 (Image 06)

Instructional illustration showing hands using a dry powder inhaler to administer medication by placing the device's mouthpiece near the mouth and releasing the powder into the airflow. The image is labeled as Figure 4.*

FDA Label Image

Figure 5 (Image 07)

An instructional illustration showing a person using a red inhaler device by placing its mouthpiece in the mouth. The inhaler cap is removed and hanging below, indicating proper use technique for inhalation.*

FDA Label Image

Label Image (Lbl530022666)

Packaging label for Budesonide and Formoterol Fumarate Dihydrate 80-4.5 aerosol inhaler by RPK Pharmaceuticals, Inc. The label includes usage instructions, a caution to read the patient medguide, the product NDC 53002-2666, and spaces for clinic and prescriber names, and patient 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.