Budesonide Inhalant
Product Images NDC 64980-639

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Budesonide (NDC 64980-639). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rising Pharma Holdings, 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

0.25mg-cartonlabel (0.25mg Cartonlabel)

Packaging label for Budesonide inhalation suspension, strength 0.25 mg/2 mL. The label indicates the product is for inhalation only, contains 30 packages with 2 mL unit-dose single-dose ampules, and is labeled by Rising Pharma Holdings, Inc. The label shows the NDC 64989-638-03 and highlights the Rx only status.*

FDA Label Image

0.5mg-cartonlabel (0.5mg Cartonlabel)

Packaging label for Budesonide Inhalation Suspension 0.5 mg/2 mL by Rising Pharma Holdings, Inc. The label indicates a box containing 30 packets (5 each) of 2 mL plastic single-dose ampules for inhalation use only. The label features the product name, strength, dosage form, NDC code, and usage instructions in a folded carton design.*

FDA Label Image

Figure-1 (Figure 1)

A line graph titled 'A 12-Week Trial in Pediatric Patients Not on Inhaled Corticosteroid Therapy Prior to Study Entry. Nighttime Asthma Change from Baseline'. The y-axis represents the mean change from baseline in nighttime asthma symptoms, ranging from 0.0 to -0.6. The x-axis shows time points from baseline through weeks 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, and overall weeks 0-12. Four lines compare placebo, 0.25 mg once daily, 0.5 mg once daily, and 1 mg once daily doses, each showing decreasing nighttime asthma symptoms over time. Statistical p-values are listed for each dosage group versus placebo.*

FDA Label Image

Figure-2 (Figure 2)

A line graph depicting mean changes from baseline in nighttime asthma symptoms over a 12-week trial in pediatric patients previously on inhaled corticosteroid therapy. The x-axis shows time intervals from baseline to 12 weeks, and the y-axis shows mean symptom change. Three lines represent placebo, 0.25 mg twice daily, and 0.5 mg twice daily dosing groups, with p-values noted for the active doses.*

FDA Label Image

Figure-3 (Figure 3)

A line graph showing mean change from baseline in nighttime asthma symptoms over a 12-week period in pediatric patients. The graph compares five groups: placebo, 0.25 mg once daily, 0.25 mg twice daily, 0.5 mg twice daily, and 1 mg once daily doses of Budesonide inhalant. The x-axis represents time intervals from baseline through weeks 0-12, and the y-axis represents mean change from baseline in symptoms.*

FDA Label Image

Foil-label-0.25mg2ml (Foil Label 0.25mg2ml)

Budesonide Inhalation Suspension 0.25 mg/2 mL single-dose ampules for inhalation only, by Rising Pharma Holdings, Inc. This label includes product use instructions, storage conditions, and ingredient details. The package contains 5 x 2 mL single-dose ampules, intended for use in a jet nebulizer only.*

FDA Label Image

Foil-label-0.5mg2ml (Foil Label 0.5mg2ml)

The label for Budesonide Inhalation Suspension 0.5 mg/2 mL from Rising Pharma Holdings, Inc. It is a human prescription drug for inhalation use. The label details a package of 5 single-dose 2 mL plastic ampules, emphasizing storage instructions, usage directions, and warnings to maintain sterility and proper handling.*

FDA Label Image

Ifu-fig-1 (Ifu Fig 1)

Illustrative diagram showing a hand holding five single-use plastic ampules, typically used for dispensing liquid medication. Four ampules are aligned together vertically while the fifth is held separately to the right. This figure likely depicts a step related to the handling or preparation of inhalant medication.*

FDA Label Image

Ifu-fig-2 (Ifu Fig 2)

An instructional illustration labeled Figure 2 showing a hand holding a small inhalant device or cartridge, with an arrow indicating a twisting or rotating motion to presumably open or activate the device.*

FDA Label Image

Ifu-fig-3 (Ifu Fig 3)

An instructional diagram labeled Figure 3 depicting hands preparing a single-dose inhalant ampule by twisting or breaking the top for use. The image focuses on the technique of opening the inhalant container properly before administration.*

FDA Label Image

Ifu-fig-4 (Ifu Fig 4)

Illustration demonstrating a hand holding an inhalant vial while another hand uses a dropper or pipette to extract liquid from the vial, likely showing preparation or dosing steps for Budesonide inhalant.*

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Nephron-logo (Nephron Logo)

FDA Label Image

Structure (Structure)

Chemical structure of Budesonide, showing its steroid framework with various functional groups and an additional smaller molecule structure likely representing a related compound or byproduct.*

* 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.