Budesonide Suspension
Product Images NDC 47335-631

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Budesonide (NDC 47335-631). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sun Pharmaceutical Industries, 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

Spl-budesonide-carton-1 (Spl Budesonide Carton 1)

Budesonide Inhalation Suspension 0.5 mg/2 mL label from Sun Pharmaceutical Industries, Inc. The label states this is a respiratory inhalation suspension for inhalation only, with 30 sterile single-dose ampules per carton. Instructions for use, storage directions, manufacturer and distributor information, barcode, and dosage details are visible.*

FDA Label Image

Spl-budesonide-carton-2 (Spl Budesonide Carton 2)

Label for Budesonide Inhalation Suspension 0.25 mg/2 mL by Sun Pharmaceutical Industries, Inc. The label states the product is for inhalation only and includes storage instructions to keep the ampules upright. It contains 30 sterile single-dose 2 mL ampules packaged as 5 ampules per pouch with 6 pouches per carton. Usage instructions and manufacturer details are also included.*

FDA Label Image

Spl-budesonide-carton-3 (Spl Budesonide Carton 3)

Label for Budesonide Inhalation Suspension 1 mg/2 mL sterile single-dose ampules by Sun Pharmaceutical Industries, Inc. The carton contains 30 ampules packaged as 5 ampules per pouch, 6 pouches per carton. Directions for use with a jet nebulizer and storage instructions are included, along with manufacturer details from Sun Pharmaceutical Medicare Limited, India.*

FDA Label Image

Spl-budesonide-fig-1 (Spl Budesonide Fig 1)

A line graph showing mean change from baseline in nighttime asthma symptoms over a 12-week trial in pediatric patients not previously on inhaled corticosteroid therapy. The graph compares placebo and three budesonide suspension strengths (0.25 mg, 0.5 mg, 1 mg once daily), with time intervals on the x-axis and symptom change on the y-axis. Each treatment group's trend is plotted to illustrate symptom improvement over weeks 0 to 12.*

FDA Label Image

Spl-budesonide-fig-2 (Spl Budesonide Fig 2)

Line graph titled 'A 12-Week Trial in Pediatric Patients Previously Maintained on Inhaled Corticosteroid Therapy Prior to Study Entry' showing nighttime asthma change from baseline. Three lines represent placebo, Budesonide 0.25 mg twice daily, and Budesonide 0.5 mg twice daily over intervals from baseline to week 12. The y-axis shows mean change from baseline nighttime asthma symptoms, ranging from -0.6 to 0.1. P-values for 0.25 mg and 0.5 mg doses are indicated as 0.022 and 0.021, respectively.*

FDA Label Image

Spl-budesonide-fig-3 (Spl Budesonide Fig 3)

A line graph titled 'A 12-Week Trial in Pediatric Patients' showing nighttime asthma symptom changes from baseline over 12 weeks. The graph compares placebo, Budesonide 0.25 mg once daily, 0.25 mg twice daily, 0.5 mg twice daily, and 1.0 mg once daily dosages. The y-axis represents mean change from baseline in nighttime asthma symptoms, and the x-axis shows time intervals from baseline through weeks 0-12.*

FDA Label Image

Spl-budesonide-fig-4 (Spl Budesonide Fig 4)

An illustration showing a pair of hands holding a strip of five single-use ampules. Each ampule is labeled "STERILE For oral inhalation only" and includes fields for batch number and expiration date. The ampules are connected in a strip, and the top tab shows partial text "SUN PHARMA" indicating Sun Pharmaceutical Industries, Inc. as the labeler.*

FDA Label Image

Spl-budesonide-fig-5 (Spl Budesonide Fig 5)

An instructional illustration showing a hand holding a single-dose vial labeled 'STERILE For oral inhalation only.' The vial has a breakable top cap being twisted off, indicated by a curved arrow. The vial also features space for batch number and expiration date markings.*

FDA Label Image

Spl-budesonide-fig-6 (Spl Budesonide Fig 6)

An instructional illustration showing hands opening a Budesonide respiratory suspension vial by twisting off the top cap. The vial label is partially visible with the text 'For oral inhalation only' and the labeler name Sun Pharmaceutical Industries, Inc. The image demonstrates preparation for inhalation use.*

FDA Label Image

Spl-budesonide-fig-7 (Spl Budesonide Fig 7)

Illustration showing a person holding a small vial labeled 'STERILE For oral inhalation only' and dispensing a drop of suspension into a respiratory inhalation device held in the other hand. This depicts the preparation or use of Budesonide suspension for inhalation.*

FDA Label Image

Spl-budesonide-pouch-0-5 (Spl Budesonide Pouch 0 5)

Drug Facts label for Budesonide Inhalation Suspension 0.5 mg/2 mL by Sun Pharmaceutical Industries, Inc. Describes packaging of 5 single-dose ampules, dosing instructions, storage conditions, and precautions for use in a jet nebulizer only. Includes directions to follow patient instructions and warnings about storage temperature and light exposure.*

FDA Label Image

Spl-budesonide-pouch-1 (Spl Budesonide Pouch 1)

Budesonide Inhalation Suspension 0.25 mg/2 mL in a carton label for respiratory inhalation use by Sun Pharmaceutical Industries, Inc. The package contains 5 single-dose ampules. The label includes directions for use, storage instructions, and a list of inactive ingredients. It emphasizes prescription use and inhalation route only.*

FDA Label Image

Spl-budesonide-pouch-3 (Spl Budesonide Pouch 3)

Text panel for Budesonide Inhalation Suspension 1 mg/2 mL by Sun Pharmaceutical Industries, Inc. Provides instructions for inhalation use only, dosage content per single-dose ampule, storage conditions, handling instructions, and a note to keep out of reach of children. Mentions 5 single-dose ampules and advises use within 2 weeks after opening.*

FDA Label Image

Spl-budesonide-str (Spl Budesonide Str)

Chemical structure of budesonide, showing its steroid framework with hydroxyl, methyl, and oxygen functional groups, as depicted in the image.*

* 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.