Budesonide Inhalation Suspension
Product Images NDC 68788-8503

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This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Budesonide Inhalation (NDC 68788-8503). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Preferred 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

Budesonide Inh Susp 0.5mg Per2ml (Dd74e446 7c1b 4f02 9c73 Ba716572ee77 00)

Budesonide Inh Susp 0.5mg Per2ml (Dd74e446 7c1b 4f02 9c73 Ba716572ee77 00)
This is a description for a medication called Budesonide Inhalation Suspension. The medication is available in a 0.5mg/2mL single-dose ampule. The generic name for this medication is Pulmicort. It is manufactured by Lupin Pharmaceuticals, Inc. It should be stored upright at a temperature between 20° to 25°C (68" to 77°F). The medication should not be frozen and should be protected from light. Once opened, the contents of the ampule should be used immediately. The medication is for inhalation only and should be used as directed by a physician. The description also includes instructions in both English and Spanish.*
FDA Label Image

Chemical Structure (E986c849 75fc 4c78 B593 1bd0c878adf8 01)

FDA Label Image

Image (E986c849 75fc 4c78 B593 1bd0c878adf8 02)

Image (E986c849 75fc 4c78 B593 1bd0c878adf8 02)
Nighttime Asthma Change from Baseline was evaluated. The mean change from Baseline for nighttime Asthma Symptoms was measured. The data was collected over a period of 12 weeks. Different dosage levels were administered, including 0.25 mg, 0.5 mg, and 1.0 mg once daily. The p-values for these dosage levels were calculated to be 0.001, 0.010, and 0.009 respectively.*
FDA Label Image

Image (E986c849 75fc 4c78 B593 1bd0c878adf8 03)

Image (E986c849 75fc 4c78 B593 1bd0c878adf8 03)
Nighttime Asthma Change from Baseline: The given text provides information about the mean change from baseline in nighttime asthma symptoms. The values obtained for the change from baseline are 0.1 and 0.0. The data also includes the p-values for different medication dosages: 0.25 mg (p-value: 0.022) and 0.5 mg (p-value: 0.021). However, the information provided is not sufficient to determine the context or significance of these values.*
FDA Label Image

Image (E986c849 75fc 4c78 B593 1bd0c878adf8 04)

Image (E986c849 75fc 4c78 B593 1bd0c878adf8 04)
Nighttime Asthma Change from Baseline is a study evaluating the mean change in nighttime asthma symptoms from baseline. The study includes different treatment groups receiving varying dosages of a medication. The placebo group and multiple dosage groups are compared over a period of 12 weeks. The p-values for each dosage group are provided, indicating the statistical significance of the observed changes in symptoms.*
FDA Label Image

Instructions (E986c849 75fc 4c78 B593 1bd0c878adf8 05)

FDA Label Image

Instructions (E986c849 75fc 4c78 B593 1bd0c878adf8 06)

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Instructions (E986c849 75fc 4c78 B593 1bd0c878adf8 07)

FDA Label Image

Instructions (E986c849 75fc 4c78 B593 1bd0c878adf8 08)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.