Levalbuterol Solution
Product Images NDC 35573-445

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Levalbuterol (NDC 35573-445). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Burel Pharmaceuticals, 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.

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Chem Structure (Levalbuterol Inhalation Solution 1)

Chemical structure of Levalbuterol Hydrochloride, showing the molecular arrangement including hydroxyl groups, hydroxymethyl side chain, and hydrochloride component.*

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Figure D (Levalbuterol Inhalation Solution 10)

An instructional illustration showing a hand holding a vial and inserting it into the reservoir of a respiratory inhalation device. The vial and reservoir are labeled to indicate proper placement for use with Levalbuterol solution inhalation.*

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Figure E1 (Levalbuterol Inhalation Solution 11)

An instructional diagram showing parts of a respiratory inhalation device for Levalbuterol solution. The labeled components include the mouthpiece, which attaches to the device, and the reservoir, which holds the medication solution. The diagram is black and white and focuses on device assembly.*

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Figure E2 (Levalbuterol Inhalation Solution 12)

An instructional illustration showing a face mask connected to a reservoir, likely part of an inhalation device for respiratory medication delivery. The image labels the components: 'FACE MASK' and 'RESERVOIR'.*

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Figure F (Levalbuterol Inhalation Solution 13)

An illustration showing part of a respiratory device labeled with 'COMPRESSOR' and 'NEBULIZER TUBING.' The image depicts the connection point of the nebulizer tubing to the compressor unit.*

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Figure G1 (Levalbuterol Inhalation Solution 14)

An instructional diagram showing a person using a respiratory inhalation device. The illustration labels the mouthpiece and reservoir of the device positioned at the person's mouth, indicating the correct use for inhalation.*

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Figure G2 (Levalbuterol Inhalation Solution 15)

An instructional diagram showing the proper placement of a face mask over a patient's nose and mouth. The mask covers the face and connects to a medication reservoir attached to a hand-held respiratory inhalation device, illustrating setup for inhalation therapy.*

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Logo (Levalbuterol Inhalation Solution 16)

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Carton (Levalbuterol Inhalation Solution 17)

Packaging label for Levalbuterol Inhalation Solution, USP 0.31 mg/3 mL by Burel Pharmaceuticals, LLC. The label indicates the product is a prescription respiratory inhalation solution provided as 25 sterile unit-dose vials of 3 mL each. The label includes dosage strength, usage instructions, and barcodes.*

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Carton (Levalbuterol Inhalation Solution 18)

Levalbuterol Inhalation Solution, USP 0.63 mg/3 mL vial carton for oral inhalation, labeled Rx only. The packaging indicates a supply of 25 sterile unit-dose vials, each containing 3 mL of solution. The product is manufactured by Burel Pharmaceuticals, LLC and includes barcodes and usage warnings on the label panels.*

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Carton (Levalbuterol Inhalation Solution 19)

Packaging label for Levalbuterol Inhalation Solution, USP, strength 1.25 mg/3 mL (0.042%), manufactured by Burel Pharmaceuticals, LLC. The label indicates the dosage form as a respiratory inhalation solution, packaged as 25 x 3 mL sterile unit-dose vials (one pouch containing 25 vials). The label includes barcodes and usage instructions specifying oral inhalation only, along with the Rx only designation.*

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Figure 1 (Levalbuterol Inhalation Solution 2)

A line graph depicting mean change in FEV1 (percent) over time in hours for four groups: Lev 1.25, Lev 0.63, Rac 2.5, and PBO. The graph shows a rapid increase in FEV1 within the first hour for all groups except PBO, followed by a gradual decline over 8 hours. Lev 1.25 consistently demonstrates the highest mean change, with PBO showing the least response.*

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Figure 2 (Levalbuterol Inhalation Solution 3)

A line graph showing mean change in FEV1 (%) over time (hours) for different treatment groups including Levalbuterol at 1.25 mg, 0.63 mg, Racemic 2.5 mg, and placebo (PBO). The graph displays the effect of these treatments on lung function from 0 to 8 hours, with a 15% change reference line.*

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Figure 3 (Levalbuterol Inhalation Solution 4)

A line graph showing the mean change in FEV1 (%) over 4 hours for different treatments: Levalbuterol 0.63 mg and 0.31 mg, Racemic albuterol 2.5 mg and 1.25 mg, and placebo. The y-axis represents mean change in FEV1 (%) and the x-axis represents time in hours. The graph includes a dashed line indicating a 15% change in FEV1.*

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Figure 4 (Levalbuterol Inhalation Solution 5)

A line graph showing mean change in FEV1 (%) over time (hours) for different Levalbuterol and Racemic formulations compared to placebo. The chart displays multiple lines representing varying doses and their effect on lung function decline from 0 to 4 hours post-administration.*

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Logo (Levalbuterol Inhalation Solution 6)

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Figure A (Levalbuterol Inhalation Solution 7)

An instructional diagram illustrating the twist-off tab portion of a vial, with labels indicating 'twist off tab' on both sides of the top. Shading highlights the section of the vial that is designed to be twisted off for opening.*

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Figure B (Levalbuterol Inhalation Solution 8)

An instructional illustration showing the top portion of a pouch with a tear notch labeled "TEAR AT SEAM". The image emphasizes where to open the pouch by tearing at the seam above the resealable closure.*

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Figure C (Levalbuterol Inhalation Solution 9)

An instructional diagram showing a hand holding an ampule and snapping off its top at the scored neck. The image demonstrates how to open a glass ampule for inhalation solution 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.