Levalbuterol Solution, Concentrate
Product Images NDC 65862-942

View Photos of 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 Levalbuterol (NDC 65862-942). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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

Figure 1 (Levalbuterol Fig1)

Figure 1 (Levalbuterol Fig1)
This text represents a figure showing the mean percent change from baseline forced expiratory volume (FEV) on day 1 for adults and adolescents greater than 12 years old. The figure compares the effects of different treatments on FEV. The treatments displayed are Lev1.25, Lev0.63, Rac25, and PBO. The text shows a graph with the percent change in FEV on the y-axis and time in hours on the x-axis. The text provides information on the number of participants (n) for each treatment displayed on the graph.*
FDA Label Image

Figure F (Levalbuterol Fig10)

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Figure G.1, G.2 (Levalbuterol Fig11)

FDA Label Image

Package Label-principal Display Panel (1.25 mg/0.5 mL)

Package Label-principal Display Panel (1.25 mg/0.5 mL)
This is a prescription inhalation solution in a 0.5 ml sterile vial that contains 125mg of Levalbuterol. It is a concentrate and should be diluted before use. It is prescribed by physicians and should not be exceeded from the recommended dose. The solution contains no preservatives and should be protected from light. It should be kept at temperature between 20-25°C. The package should be discarded if the solution is not colorless. The product is distributed by Aurobindo Pharma USA.*
FDA Label Image

Package Label-principal Display Panel (1.25 mg/0.5 mL)

Package Label-principal Display Panel (1.25 mg/0.5 mL)
This is a description of Levalbuterol, which is an inhalation solution medication used to treat asthma and other respiratory conditions. It is distributed by Aurobindo Pharma USA, Inc. Each 0.5 mL unit-dose vial contains 1.25 mg of levalbuterol hydrochloride in an aqueous solution containing sodium, sodium citrate dihydrate, sodium chloride, and hydrochloric acid. The solution is intended for oral inhalation only and must be diluted before use. It is available in sterile unit-dose vials and must be protected from light and stored at a controlled room temperature. This medication is only to be used as directed by a physician and should be discarded if the solution is not colorless.*
FDA Label Image

Figure 2 (Levalbuterol Fig2)

Figure 2 (Levalbuterol Fig2)
This text provides data on the mean percent change in Forced Expiratory Volume (FEV) from baseline for adults and adolescents over the age of 12 on Day 29. The data is presented in a graph with four different treatment groups: Lev1.25, Lev 063, Rac 25, and PBO (placebo), with the number of participants in each group. The mean change in FEV is shown to be 15% and the graph also includes a time scale in hours.*
FDA Label Image

Figure 3 (Levalbuterol Fig3)

Figure 3 (Levalbuterol Fig3)
The given text appears to be a statistical analysis of Mean Percent Change from Baseline FEV (Forced Expiratory Volume) in children aged 6 to 11 years on Day 1. It includes the comparison of different treatments (Lev0.63, Lev0.31, Rac 2.5, Rac 1.25, and Pbo) and their impact on FEV. Figure 3 displays the comparison results. Time (hours) is also mentioned on the X-axis of the graph.*
FDA Label Image

Figure 4 (Levalbuterol Fig4)

FDA Label Image

Figure A (Levalbuterol Fig5)

FDA Label Image

Figure B (Levalbuterol Fig6)

FDA Label Image

Figure C (Levalbuterol Fig7)

FDA Label Image

Figure D (Levalbuterol Fig8)

FDA Label Image

Figure E.1, E.2 (Levalbuterol Fig9)

Figure E.1, E.2 (Levalbuterol Fig9)
This is a product called "mouthpiece face mask". Two figures (E.1 and E.2) are shown, which may presumably depict the product from different angles. No further information or context is available.*
FDA Label Image

Chemical Structure (Levalbuterol Str)

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