Levalbuterol Inhalation Solution
Product Images NDC 47335-743

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Levalbuterol Inhalation Solution (NDC 47335-743). 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.

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Levalbuterol-chemical-structure (Levalbuterol Chemical Structure)

Chemical structure of Levalbuterol hydrochloride, the active ingredient in Levalbuterol Inhalation Solution. The structure shows the aromatic ring with hydroxyl groups, a side chain with an amine group, and associated hydrochloride component.*

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Levalbuterol-figure-1 (Levalbuterol Figure 1)

A line graph showing the mean percent change from baseline FEV1 on Day 1 in adults and adolescents aged 12 years and older. The graph compares Levalbuterol Inhalation Solution at 1.25 mg and 0.63 mg doses, Racemic albuterol 2.5 mg, and placebo over an 8-hour period, with measurements marked at different time points and a 15% reference line indicated on the y-axis.*

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Levalbuterol-figure-2 (Levalbuterol Figure 2)

A line graph titled 'Mean Percent Change from Baseline FEV1 on Day 29, Adults and Adolescents ≥12 years old' showing mean percent change in FEV1 (%) over time (hours) from 0 to 8 hours. The graph compares four groups: Levalbuterol Inhalation Solution 1.25 mg/3mL, 0.63 mg/3mL, Racemic Albuterol 2.5 mg, and placebo (PBO), with each group represented by different markers. The 1.25 mg Levalbuterol group shows the highest increase in FEV1 reaching around 35-37% at 1 hour, followed by gradual decline to about 15% at 8 hours. Other groups show lower and varying responses over time, with placebo remaining near 10-15%. A horizontal dashed line marks 15% mean change.*

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Levalbuterol-figure-3 (Levalbuterol Figure 3)

A line graph titled "Mean Percent Change from Baseline FEV1 on Day 1, Children 6 to 11 Years of Age." The x-axis represents time in hours (0 to 4 hours), and the y-axis shows mean change in FEV1 percentage, ranging from -5% to 30%. The graph compares five groups: Levalbuterol (Lev) inhalation solution at 0.63 mg and 0.31 mg, racemic albuterol (Rec) at 2.5 mg and 1.25 mg, and placebo (Pbo). The lines show mean percent changes over time, with Levalbuterol and racemic albuterol groups showing higher improvement than placebo, peaking around 1 hour and gradually declining by 4 hours.*

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Levalbuterol-figure-4 (Levalbuterol Figure 4)

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 time (hours) for five groups: Lev 0.63 mg, Lev 0.31 mg, Rac 2.5 mg, Rac 1.25 mg, and placebo. The graph plots mean change percentage on the Y-axis and time in hours on the X-axis, with measurements up to 4 hours.*

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A (Levalbuterol Figure A)

An illustration showing a vertical vial or ampule with a rounded top and a narrow neck, labeled as Figure A. The vial appears to contain a solution, consistent with inhalation solution packaging.*

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B (Levalbuterol Figure B)

Illustration labeled Figure B showing the top edge of a bag or pouch with notches on both sides near the sealed area, indicating tear points or opening guides for the package.*

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C (Levalbuterol Figure C)

Illustration labeled Figure C showing hands holding a single-dose vial of Levalbuterol Inhalation Solution. The vial is enclosed in a plastic container, demonstrating how to hold it securely, likely as part of preparation for respiratory inhalation use.*

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D (Levalbuterol Figure D)

An instructional diagram showing a hand inserting a labeled vial into a reservoir. The vial is held between the thumb and index finger, positioned above the reservoir with the word "RESERVOIR" visible. This likely demonstrates part of the preparation or assembly process for Levalbuterol Inhalation Solution delivery device.*

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E (Levalbuterol Figure E1 E2)

An instructional diagram showing components of a respiratory inhalation device used with Levalbuterol Inhalation Solution. The left panel labels a mouthpiece and a reservoir container with a cap. The right panel shows a face mask attached to the reservoir, highlighting alternative delivery interfaces.*

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F (Levalbuterol Figure F)

An instructional diagram showing a medical compressor with a knob, a power switch, and a connected nebulizer tubing. The labels identify the compressor and nebulizer tubing components, indicating the setup of a nebulizer system for inhalation therapy.*

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G (Levalbuterol Figure G1 G2)

Instructional diagram showing two methods of using an inhalation solution device with a reservoir. Figure G.1 illustrates inhaling through a mouthpiece attached to the reservoir. Figure G.2 illustrates inhaling through a face mask attached to the reservoir. Both figures highlight the reservoir and the inhalation interface (mouthpiece or face mask).*

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Levalbuterol-label-1 (Levalbuterol Label 1)

Packaging label for Levalbuterol Inhalation Solution USP 0.31 mg/3 mL by Sun Pharmaceutical Industries, Inc. The label indicates sterile unit-dose vials, with 30 x 3 mL vials per carton (5 vials per pouch, 6 pouches per carton). It includes directions for pharmacist dispensing and storage instructions. The product is for oral inhalation only and marked Rx only.*

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2 (Levalbuterol Label 2)

Packaging label for Levalbuterol Inhalation Solution, USP 0.63 mg/3 mL by Sun Pharmaceutical Industries, Inc. The label indicates sterile unit-dose vials for oral inhalation only, with 30 vials in total (5-unit dose vials per pouch, 6 pouches per carton). Instructions note potency is expressed as levalbuterol and include storage and usage information.*

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Levalbuterol-label-3 (Levalbuterol Label 3)

Levalbuterol Inhalation Solution, USP 1.25 mg/3 mL unit-dose vial carton label from Sun Pharmaceutical Industries, Inc. The label shows product strength, dosage form as solution for oral inhalation only, NDC 47335-753-52, package size of 30 sterile unit-dose vials (5 vials per pouch, 6 pouches per carton), and manufacturer details. Storage and usage instructions are included.*

* 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.