Xopenex
Product Images NDC 17478-171

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Xopenex (NDC 17478-171). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Akorn, 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 (Xop06 0007 01)

Chemical structure of the active ingredient in Xopenex, showing the molecular arrangement with hydroxyl groups and a tertiary amine, complexed with hydrochloride (HCl).*

FDA Label Image

Figure 1 (Xop06 0007 02)

A line graph depicting mean change in FEV1 (%) over time (hours) for different treatments labeled as Lev 1.25, Lev 0.63, Rac 2.5, and PBO, with sample sizes indicated. The x-axis shows time in hours (0 to 8), and the y-axis shows mean change in FEV1 (%) from -5% to 45%. A horizontal line marks the 15% change level.*

FDA Label Image

Figure 2 (Xop06 0007 03)

A line graph depicting the mean change in FEV1 percentage over time in hours, comparing four groups labeled Lev 1.25, Lev 0.63, Rac 2.5, and PBO. The graph shows results from baseline to 8 hours, illustrating differences in respiratory function response among the groups.*

FDA Label Image

Figure 3 (Xop06 0007 04)

A line graph showing mean percent change in FEV1 over 4 hours for five different treatments or dosages: Lev 0.63, Lev 0.31, Rac 2.5, Rac 1.25, and Placebo (Pbo). The x-axis represents time in hours from 0 to 4, and the y-axis shows mean change in FEV1 percentage from -5% to 30%, with a marked reference line at 15%.*

FDA Label Image

Figure 4 (Xop06 0007 05)

Line graph showing mean change in FEV1 (%) over time (hours) for different doses of Xopenex (Lev 0.63, Lev 0.31) and Racemic albuterol (Rac 2.5, Rac 1.25) compared to placebo (Pbo). The graph depicts lung function improvement trends for each treatment group over a 4-hour period.*

FDA Label Image

Figure A (Xop06 0007 06)

An illustration showing the top portion of a vial labeled X-top, highlighting the twist-off tab. The shaded area on the vial indicates the part of the vial that functions as the twist-off tab, with arrows and text instructing to twist off the tab for vial opening.*

FDA Label Image

Figure B (Xop06 0007 07)

An instructional illustration showing a close-up of a pouch or packet with an arrow pointing to a 'tear at notch' location along the top edge, indicating where to open the packaging.*

FDA Label Image

Figure C (Xop06 0007 08)

An instructional line drawing showing how to use the Xopenex X-top device. The image depicts a hand holding the device, illustrating the step of removing or adjusting the top by pulling it upward.*

FDA Label Image

Figure D (Xop06 0007 09)

An instructional diagram showing a hand inserting or placing a vial labeled 'VIAL' into a component labeled 'RESERVOIR'. The image emphasizes the correct positioning of the vial into the reservoir part of a device, likely related to preparation or assembly instructions for medication administration.*

FDA Label Image

Figure E (Xop06 0007 10)

An instructional illustration showing a cylindrical reservoir labeled 'RESERVOIR' with arrows indicating it should be rotated or shaken. The diagram likely demonstrates part of the preparation or usage procedure for the Xopenex product.*

FDA Label Image

Figure F.1 (Xop06 0007 11)

An instructional diagram showing a device labeled with its parts: the mouthpiece at one end and the reservoir on the opposite side. The illustration outlines the key components of the device used for inhalation.*

FDA Label Image

Figure F.2 (Xop06 0007 12)

Illustration showing the components of a medical nebulizer, highlighting the face mask and medication reservoir parts connected via tubing to a device.*

FDA Label Image

Figure G (Xop06 0007 13)

An illustration showing a close-up of a nebulizer setup, featuring a compressor device with a labeled on/off switch and attached nebulizer tubing. The labels 'COMPRESSOR' and 'NEBULIZER TUBING' are clearly visible, indicating components of the nebulizer system.*

FDA Label Image

Figure H.1 (Xop06 0007 14)

An instructional illustration showing a person using a Xopenex inhaler. The diagram highlights the mouthpiece and the reservoir of the inhaler, demonstrating the correct method of inhalation.*

FDA Label Image

Figure H.2 (Xop06 0007 15)

An instructional diagram showing a face mask connected to a reservoir. The image emphasizes the components labeled as 'FACE MASK' and 'RESERVOIR,' likely depicting a nebulizer setup or inhalation device parts.*

FDA Label Image

Principal Display Panel Text For Pouch Label (Xop06 0007 16)

Packaging label for Xopenex (levalbuterol HCl) Inhalation Solution Concentrate 1.25 mg/0.5 mL by Akorn. The label specifies a sterile unit-dose vial of 0.5 mL containing 1.25 mg levalbuterol as hydrochloride, with directions to dilute before use. Storage instructions and warnings are included, along with barcodes and manufacturer information.*

FDA Label Image

Principal Display Panel Text For Carton Label (Xop06 0007 17)

Xopenex (levalbuterol HCl) Inhalation Solution Concentrate 1.25 mg/0.5 mL packaging label by Akorn. The label indicates 30 sterile unit-dose vials of 0.5 mL each for oral inhalation only. It highlights potency expressed as levalbuterol and notes dilution is required before use.*

* 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.