Levalbuterol Solution
Product Images NDC 0115-9931

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Levalbuterol (NDC 0115-9931). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals Of New York Llc, 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

Chemical Structure (Levalbuterol Inhalation Solution Usp 1)

Chemical Structure (Levalbuterol Inhalation Solution Usp 1)
Chemical structure of Levalbuterol Hydrochloride, showing the molecular components and arrangement including hydroxyl groups and the hydrochloride salt.*
FDA Label Image

Figure E1 (Levalbuterol Inhalation Solution Usp 10)

Figure E1 (Levalbuterol Inhalation Solution Usp 10)
An instructional diagram showing a respiratory inhalation device labeled with key parts: the mouthpiece and reservoir. The device is cylindrical with a detachable mouthpiece at the top and a reservoir section below. The illustration highlights components relevant to the use of a respiratory solution inhalation device.*
FDA Label Image

Figure E2 (Levalbuterol Inhalation Solution Usp 11)

Figure E2 (Levalbuterol Inhalation Solution Usp 11)
An instructional illustration showing a face mask connected to a reservoir, which is attached to a respiratory inhalation device. The components are labeled as FACE MASK and RESERVOIR, indicating parts of an inhalation delivery system for a solution medication.*
FDA Label Image

Figure F (Levalbuterol Inhalation Solution Usp 12)

Figure F (Levalbuterol Inhalation Solution Usp 12)
An instructional illustration showing a compressor device labeled 'COMPRESSOR' and a piece of nebulizer tubing connected to it, labeled 'NEBULIZER TUBING.' This diagram likely depicts a component setup for respiratory inhalation therapy using a nebulizer system.*
FDA Label Image

Figure G1 (Levalbuterol Inhalation Solution Usp 13)

Figure G1 (Levalbuterol Inhalation Solution Usp 13)
An instructional illustration showing the use of a respiratory inhalation solution device. It highlights the mouthpiece where the user inhales and the reservoir containing the medication. The diagram is likely associated with the Levalbuterol inhalation solution.*
FDA Label Image

Figure G2 (Levalbuterol Inhalation Solution Usp 14)

Figure G2 (Levalbuterol Inhalation Solution Usp 14)
An instructional diagram showing a respiratory inhalation device with labeled parts: a face mask and a reservoir. The image likely illustrates the use or assembly of the inhalation system for administering the medication.*
FDA Label Image

0.31mg_3 mL (Levalbuterol Inhalation Solution Usp 15)

0.31mg_3 mL (Levalbuterol Inhalation Solution Usp 15)
Packaging label for Levalbuterol Inhalation Solution, USP 0.31 mg/3 mL by Amneal Pharmaceuticals of New York LLC. The label identifies the product as a respiratory inhalation solution with each 3 mL unit-dose vial containing 0.31 mg of levalbuterol hydrochloride. The label includes storage instructions, manufacturer and distributor information, barcodes, lot and serialization area, and the Amneal logo.*
FDA Label Image

0.63 mg_3ml (Levalbuterol Inhalation Solution Usp 16)

0.63 mg_3ml (Levalbuterol Inhalation Solution Usp 16)
Packaging label for Levalbuterol Inhalation Solution USP 0.63 mg/3 mL by Amneal Pharmaceuticals of New York LLC. The label includes dosage strength, usage direction as inhalation solution, storage instructions, and manufacturer and distributor information. It also features a barcode and the Amneal logo on a yellow background.*
FDA Label Image

1.25 mg_3 mL (Levalbuterol Inhalation Solution Usp 17)

1.25 mg_3 mL (Levalbuterol Inhalation Solution Usp 17)
Packaging label for Levalbuterol Inhalation Solution, USP, 1.25 mg (0.042%) strength in 3 mL unit-dose vials. The label includes the NDC 0115-9932-78 and indicates it is distributed by Amneal Pharmaceuticals LLC and manufactured by The Ritedose Corporation. It is a respiratory inhalation solution intended for oral inhalation only, with storage instructions and pharmacist attention notes included. The logo of Amneal appears at the bottom of the label.*
FDA Label Image

Figure 1 (Levalbuterol Inhalation Solution Usp 2)

Figure 1 (Levalbuterol Inhalation Solution Usp 2)
A line graph showing mean change in FEV1 (forced expiratory volume) over time up to 8 hours for different doses of Levalbuterol (0.25 mg, 0.63 mg), Racemic albuterol 2.5 mg, and placebo. The plot compares respiratory drug effects with lines marked by different symbols for each group.*
FDA Label Image

Figure 2 (Levalbuterol Inhalation Solution Usp 3)

Figure 2 (Levalbuterol Inhalation Solution Usp 3)
A line graph showing mean change in FEV1 percentage over time up to 8 hours following inhalation. The graph compares responses for Levalbuterol at concentrations of 1.25 mg (circle), 0.63 mg (square), Racemic albuterol 2.5 mg (triangle), and placebo (cross). Data points show peak effects around 1 hour, with a gradual decline thereafter.*
FDA Label Image

Figure 3 (Levalbuterol Inhalation Solution Usp 4)

Figure 3 (Levalbuterol Inhalation Solution Usp 4)
Line graph showing mean change in FEV1 (%) over time (hours) comparing different doses of Levalbuterol (Lev 0.31 mg and Lev 0.63 mg), Racemic albuterol (Rac 1.25 mg and Rac 2.5 mg), and placebo (Pbo). The graph depicts variations in lung function up to 4 hours post-dose with sample sizes indicated for each group.*
FDA Label Image

Figure 4 (Levalbuterol Inhalation Solution Usp 5)

Figure 4 (Levalbuterol Inhalation Solution Usp 5)
A line graph depicting the mean change in FEV1 (%) over time (hours) for different doses of Levalbuterol (0.31 mg, 0.63 mg), Racemic albuterol (1.25 mg, 2.5 mg), and placebo. The x-axis represents time up to 4 hours, and the y-axis shows percent mean change in FEV1 up to 30%. Various distinct lines and markers represent each treatment group, showing changes in respiratory function after inhalation.*
FDA Label Image

Figure A (Levalbuterol Inhalation Solution Usp 6)

Figure A (Levalbuterol Inhalation Solution Usp 6)
An instructional diagram showing a unit-dose vial with the twist-off tab portion shaded. The diagram highlights and labels the twist-off tabs at the top of the vial for use in respiratory inhalation solution administration.*
FDA Label Image

Figure B (Levalbuterol Inhalation Solution Usp 7)

Figure B (Levalbuterol Inhalation Solution Usp 7)
An instructional illustration depicting a pouch with a visible tear seam, indicated by an arrow labeled 'TEAR AT SEAM.' This diagram visually guides the user on how to open the pouch packaging.*
FDA Label Image

Figure C (Levalbuterol Inhalation Solution Usp 8)

Figure C (Levalbuterol Inhalation Solution Usp 8)
An instructional illustration showing two hands opening a single-dose vial or ampule by twisting or snapping the top section off. The image is a line drawing emphasizing the correct technique to open the vial for respiratory inhalation solution use.*
FDA Label Image

Figure D (Levalbuterol Inhalation Solution Usp 9)

Figure D (Levalbuterol Inhalation Solution Usp 9)
An instructional illustration showing a hand holding a vial above a labeled reservoir, indicating that the vial's contents are being poured or inserted into the reservoir. This diagram appears to demonstrate part of the preparation or assembly process for a respiratory inhalation solution device.*

* 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.