Levalbuterol Solution
Product Images NDC 65862-944

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Levalbuterol (NDC 65862-944). 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.

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Figure 1 (Levalbuterol Fig1)

Line graph showing mean percent change from baseline FEV1 on day 1 in adults and adolescents 12 years and older. The graph compares four groups: Levalbuterol at 1.25 mg, 0.63 mg, Racemic Albuterol at 2.5 mg, and placebo, measured over 8 hours. The vertical axis represents percent change in FEV1 and the horizontal axis is time in hours.*

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Figure F.1, F.2 (Levalbuterol Fig10)

Instructional diagram showing two methods of using a Levalbuterol respiratory inhalation solution device. Figure F.1 demonstrates inhalation through a mouthpiece with the reservoir in place, while Figure F.2 illustrates inhalation via a face mask attached to the reservoir.*

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Package Label-principal Display Panel (0.31 mg/3 mL)

Levalbuterol Inhalation Solution USP 0.31 mg/3 mL in sterile unit-dose vials, packaged 12 vials per carton. Label indicates potency expressed as levalbuterol, for oral inhalation only. Distributed by Aurobindo Pharma USA, Inc. Storage instructions and usage warnings are also present on the label. NDC 65862-943-12.*

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Package Label-principal Display Panel (0.31 mg/3 mL)

Packaging label for Levalbuterol Inhalation Solution, USP 0.31 mg/3 mL by Aurobindo Pharma Limited. The label shows it is an oral inhalation solution supplied as 24 sterile unit-dose vials of 3 mL each, with potency expressed as levalbuterol. Directions indicate Rx only and storage instructions are included.*

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Package Label-principal Display Panel (0.63 mg/3 mL)

Levalbuterol Inhalation Solution USP 0.63 mg/3 mL unit-dose vial label from Aurobindo Pharma. The label states Rx Only and indicates 12 sterile 3 mL unit-dose vials per package. It includes storage instructions, usage warnings, and distributor information for Aurobindo Pharma USA, Inc. The label also features a barcode and lot code area.*

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Package Label-principal Display Panel (0.63 mg/3 mL)

Packaging label for Levalbuterol Inhalation Solution, USP 0.63 mg/3 mL by Aurobindo Pharma Limited. The label indicates it is an oral inhalation solution supplied as 24 sterile unit-dose vials, each 3 mL. The label includes storage instructions, dosage warnings, and distributor information for Aurobindo Pharma USA, Inc.*

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Package Label-principal Display Panel (1.25 mg/3 mL)

Label for Levalbuterol Inhalation Solution, USP 1.25 mg/3 mL provided by Aurobindo Pharma Limited. The label specifies it is for oral inhalation only, available in 12 sterile unit-dose vials of 3 mL each. The label includes storage instructions, pharmacist attention notes, and distributor information showing Aurobindo Pharma USA, Inc., East Windsor, NJ.*

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Package Label-principal Display Panel (1.25 mg/3 mL)

Levalbuterol Inhalation Solution, USP 1.25 mg/3 mL sterile unit-dose vials packaging label. The label indicates oral inhalation dosage with 24 x 3 mL vials per carton. It includes storage instructions, dosage cautions, and highlights potency expressed as levalbuterol. Distributed by Aurobindo Pharma USA, Inc., made in India.*

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Figure 2 (Levalbuterol Fig2)

A line graph titled 'Mean Percent Change from Baseline FEV1 on Day 29, Adults and Adolescents ≥12 years old,' showing mean change in FEV1 (%) on the y-axis versus time in hours on the x-axis. The graph compares Levalbuterol solution at 1.25 mg and 0.63 mg, Racemic mixture at 2.5 mg, and placebo, tracking their effects over 8 hours.*

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Figure 3 (Levalbuterol Fig3)

Line graph titled 'Mean Percent Change from Baseline FEV1 on Day 1, Children 6 to 11 Years of Age' showing mean change in FEV1 (%) over time (hours) for five groups: Lev 0.63, Lev 0.31, Rac 2.5, Rac 1.25, and Pbo (placebo). The graph illustrates changes from 0 to 4 hours, with Lev and Rac groups maintaining higher mean percent changes compared to placebo.*

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Figure 4 (Levalbuterol Fig4)

A line graph titled 'Mean Percent Change from Baseline FEV1 on Day 21, Children 6 to 11 Years of Age' showing mean percent change in FEV1 over 4 hours for different treatments: Levalbuterol 0.63 mg (diamond), Levalbuterol 0.31 mg (square), Rac 2.5 mg (triangle), Rac 1.25 mg (circle), and placebo (star). The y-axis represents mean percent change in FEV1 (%) from -5 to 30%, and the x-axis represents time in hours, from 0 to 4.*

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Figure A (Levalbuterol Fig5)

Illustration labeled 'Figure A' showing a single unit dose vial designed for respiratory inhalation solution. The vial has a tapered neck and a sealed top, typically used for medications like Levalbuterol inhalation solution.*

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Figure B (Levalbuterol Fig6)

Instructional illustration showing hands opening or manipulating a respiratory inhalation solution ampule, likely depicting how to prepare the Levalbuterol inhalation solution for use.*

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Figure C (Levalbuterol Fig7)

Black-and-white line drawing illustrating the insertion of a vial into the reservoir of an inhalation device. The hand holds a vial labeled 'VIAL' above the reservoir opening, demonstrating preparation or assembly of the respiratory solution inhaler.*

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Figure D.1, D.2 (Levalbuterol Fig8)

Illustrations showing respiratory inhalation device assembly components for Levalbuterol solution, including a mouthpiece and reservoir (Figure D.1) and a face mask with reservoir (Figure D.2). These diagrams depict setup options for administering the inhaled solution.*

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Figure E (Levalbuterol Fig9)

Illustration labeled as Figure E depicts compressor equipment with a connection for nebulizer tubing, showing how the tubing attaches to the compressor device for respiratory inhalation use.*

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Levalbuterol Hydrochloride Chemical Structure (Levalbuterol Str)

Chemical structure of Levalbuterol hydrochloride, showing the molecular arrangement including hydroxyl groups, methyl groups, and the hydrochloride component.*

* 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.