Budesonide Inhalant
Product Images NDC 76282-641

14 FDA label images from Exelan Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Budesonide (NDC 76282-641). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Exelan 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

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Bb2e8526 80f5 4cee Ab3b Fb80dfc3241e 01
Chemical structure diagram of the active ingredient Budesonide as shown in the image.*
FDA Label Image

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A line graph showing mean change from baseline in nighttime asthma symptoms over a 12-week period for patients receiving Budesonide inhalation suspension at doses of 0.25 mg, 0.5 mg, and 1.0 mg once daily compared to placebo. The vertical axis represents mean change from baseline, and the horizontal axis represents time intervals from baseline to week 12.*
FDA Label Image

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Bb2e8526 80f5 4cee Ab3b Fb80dfc3241e 03
A line graph showing the mean change from baseline in nighttime asthma symptoms over a 12-week period. The x-axis represents time intervals from baseline through various weeks up to 12 weeks. The y-axis shows the mean change from baseline, ranging from -0.6 to 0.1. Three different dosage groups are plotted: 0.25 mg twice daily, 0.5 mg twice daily, and 0.5 mg once daily, with separate lines and markers for each dosage regimen.*
FDA Label Image

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Bb2e8526 80f5 4cee Ab3b Fb80dfc3241e 04
A line graph showing mean change from baseline for nighttime asthma symptoms over time (baseline to 12 weeks) in patients using Budesonide Inhalation Suspension at various dosages and placebo. The x-axis represents time in weeks, and the y-axis shows mean change from baseline. Multiple treatment groups are plotted: placebo, 0.25 mg once daily, 0.25 mg twice daily, 0.5 mg twice daily, and 1.0 mg once daily.*
FDA Label Image

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Bb2e8526 80f5 4cee Ab3b Fb80dfc3241e 05
An instructional illustration showing a hand holding a blister strip of ampules and another hand lifting an individual ampule, suggesting how to remove a single dose from the strip. The diagram relates to the administration or preparation of Budesonide Inhalation Suspension in ampule form.*
FDA Label Image

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Bb2e8526 80f5 4cee Ab3b Fb80dfc3241e 06
An instructional illustration showing a hand holding a small vial above a device, with an arrow indicating the vial is to be inserted or twisted into the device. The image is step 2 in a sequence, likely demonstrating how to prepare or use Budesonide Inhalation Suspension.*
FDA Label Image

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Bb2e8526 80f5 4cee Ab3b Fb80dfc3241e 07
Instructional illustration showing a hand breaking open an ampule, twisting the top off to access the Budesonide Inhalation Suspension for oral inhalation.*
FDA Label Image

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An instructional illustration showing a hand holding an inhaler with the other hand removing or attaching a cap or cover. The image is step 4 in a sequence, indicating part of the device preparation or usage process for Budesonide Inhalation Suspension.*
FDA Label Image

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Label for Budesonide Inhalation Suspension 0.25 mg/2 mL oral inhalant by Exelan Pharmaceuticals, Inc. Contains 1 envelope with five 2 mL single-dose ampules. Includes dosage instructions, storage conditions, and manufacturer details. Marked Rx Only.*
FDA Label Image

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Bb2e8526 80f5 4cee Ab3b Fb80dfc3241e 10
Packaging label for Budesonide Inhalation Suspension 0.25 mg/2 mL by Exelan Pharmaceuticals, Inc. The label indicates the product is for inhalation only and includes 30 single-dose ampules per carton. Usage instructions and storage information (store upright) are also visible. The label highlights the Rx Only status and includes the NDC 76282-640-38.*
FDA Label Image

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Bb2e8526 80f5 4cee Ab3b Fb80dfc3241e 11
Label for Budesonide Inhalation Suspension 0.5 mg/2 mL by Exelan Pharmaceuticals, Inc. The label includes dosage form as inhalant for oral use, a NDC code 76282-641-37, and indicates that the package contains 1 envelope with five 2 mL single-dose ampules. Storage instructions, usage directions, and manufacturer information from India and Boca Raton, FL, are included, along with a barcode and lot/expiration date fields.*
FDA Label Image

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Bb2e8526 80f5 4cee Ab3b Fb80dfc3241e 12
Budesonide Inhalation Suspension 0.5 mg/2 mL packaging label for a 30 single-dose ampule carton, labeled for oral inhalation. The label includes directions for use with illustrations, storage instructions to store upright, and identifies Exelan Pharmaceuticals, Inc. as the manufacturer. The label also displays the NDC 76282-641-38 and highlights 'Rx Only' status.*
FDA Label Image

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Bb2e8526 80f5 4cee Ab3b Fb80dfc3241e 13
Label of Budesonide Inhalation Suspension 1 mg/2 mL by Exelan Pharmaceuticals, Inc. This oral inhalant product is provided as single-dose ampules, with one envelope containing five 2 mL ampules. The label includes storage instructions, usage caution for jet nebulizers, ingredients, manufacturer details, and a barcode with NDC 76282-642-37.*
FDA Label Image

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Bb2e8526 80f5 4cee Ab3b Fb80dfc3241e 14
Packaging label for Budesonide Inhalation Suspension 1 mg/2 mL by Exelan Pharmaceuticals, Inc. The label indicates the product is an inhalant for oral use, for inhalation only, with instructions to store upright. The carton contains 30 single-dose ampules and is labeled Rx Only. The label includes a barcode and preparatory instructions for use.*

* 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.