Levalbuterol Solution, Concentrate
Product Images NDC 0378-6993

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Levalbuterol (NDC 0378-6993). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan Pharmaceuticals 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 Hydrochloride Structural Formula (Image 01)

Chemical structure of levalbuterol hydrochloride, showing its molecular framework including hydroxyl groups, amine group, tertiary butyl group, and hydrochloride association.*

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Figure 1: Mean Percent Change From Baseline Fev1 On Day 1, Adults And Adolescents ≥ 12 Years Old (Image 02)

A line graph showing mean percent change in FEV1 (forced expiratory volume in 1 second) over time up to 8 hours for four different treatments: Lev 1.25 mg, Lev 0.63 mg, Rac 2.5 mg, and PBO (placebo). The y-axis represents percentage change while the x-axis shows time in hours, illustrating the comparative bronchodilator effects.*

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Figure 2: Mean Percent Change From Baseline Fev1 On Day 29, Adults And Adolescents ≥ 12 Years Old (Image 03)

A line graph showing Mean Change in FEV1 (%) over Time (hours) up to 8 hours. It compares four groups labeled Lev 1.25, Lev 0.63, Rac 2.5, and PBO with data points plotted for each group illustrating their FEV1 response curves over time.*

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Figure 3: Mean Percent Change From Baseline Fev1 On Day 1, Children 6 To 11 Years Of Age (Image 04)

A line graph depicting mean change in FEV1 (%) over time (hours) for different doses of levalbuterol (Lev) and racemic albuterol (Rac) compared to placebo (Pbo). The graph shows dose-dependent respiratory function improvement with various sample sizes indicated for each treatment group.*

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Figure 4: Mean Percent Change From Baseline Fev1 On Day 21, Children 6 To 11 Years Of Age (Image 05)

A line graph showing mean change in FEV1 (%) over time (hours) for six groups: Lev 0.63, Lev 0.31, Rac 2.5, Rac 1.25, Rac 1.25 (repeated), and Pbo, with sample sizes ranging from 54 to 66. The graph plots data points from 0 to 4 hours, indicating respiratory function response following different treatments.*

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Instructions For Use Figure A (Image 06)

An illustration labeled 'Figure A' depicting a vertical, elongated inhalation device or component, likely related to a respiratory inhalation solution. The device has a rounded top section and a narrower elongated bottom section. No text or labeling other than 'Figure A' is visible.*

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Instructions For Use Figure B (Image 07)

An instructional diagram labeled Figure B showing a package with a top notch and an arrow pointing to the notch labeled 'TEAR AT NOTCH.' It illustrates how to open the package by tearing at the designated notch.*

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Instructions For Use Figure C (Image 08)

An instructional illustration labeled Figure C showing a close-up of a hand holding an inhaler or similar respiratory device, demonstrating the proper positioning of the fingers around its components.*

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Instructions For Use Figure D (Image 09)

Illustration labeled Figure D showing a hand holding a vial above a reservoir chamber, presumably demonstrating the transfer of medication from the vial into the reservoir for inhalation use.*

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Instructions For Use Figure E (Image 10)

An instructional diagram labeled 'Figure E' showing a reservoir component, likely of an inhalation device. The image depicts how to rotate the reservoir, indicated by a circular arrow around the container.*

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Instructions For Use Figure F.1 And F.2 (Image 11)

Illustrations showing parts of a respiratory inhalation device for Levalbuterol solution concentrate. Figure F.1 labels the mouthpiece and reservoir, while Figure F.2 labels the face mask and reservoir, highlighting device components used for inhalation administration.*

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Instructions For Use Figure G (Image 12)

An illustration labeled Figure G shows a nebulizer compressor unit with a connected tubing. The compressor front panel features a knob and a rectangular display or label area, with text indicating 'COMPRESSOR' above these elements. The tubing attaches to the compressor unit at a port, representing part of a respiratory inhalation setup.*

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Instructions For Use Figure H.1 And H.2 (Image 13)

Two instructional diagrams illustrating the use of a respiratory inhalation device with Levalbuterol solution concentrate. Figure H.1 shows a user inhaling through a mouthpiece attached to the device with a reservoir. Figure H.2 depicts a user inhaling through a face mask connected to the reservoir of the device.*

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Levalbuterol Inhalation Solution, Usp (concentrate) 1.25 mg/0.5 mL Carton Label (Image 14)

Packaging label for Levalbuterol Inhalation Solution, USP (Concentrate) 1.25 mg / 0.5 mL by Mylan Pharmaceuticals Inc. The label includes dosage strength, directions to dilute before use, and states it is for oral inhalation only. The package contains 30 individually wrapped sterile unit-dose vials.*

* 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.