Levalbuterol Solution
Product Images NDC 81894-102

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Levalbuterol (NDC 81894-102). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Luoxin Aurovitas Pharma (chengdu) Co., Ltd., 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

Figure 1 (Levalbuterol Fig1)

A line graph showing the mean percent change from baseline FEV1 on Day 1 in adults and adolescents aged 12 years and older. The x-axis represents time in hours (0 to 8), and the y-axis shows mean change in FEV1 percentage (from -5 to 45%). Four lines represent different treatments: Levalbuterol 1.25 mg, Levalbuterol 0.63 mg, Racemic 2.5, and placebo. The data illustrate changes in FEV1 over time for each group, with the Levalbuterol 1.25 mg line showing the highest sustained mean percent change.*

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Figure F.1, F.2 (Levalbuterol Fig10)

Two black and white illustrations demonstrating how to use a respiratory inhalation solution device. The first shows a person using the mouthpiece with the reservoir of the inhaler visible. The second shows the same device with a face mask covering the nose and mouth, also highlighting the reservoir.*

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Levalbuterol-pouch-0.31mg (Levalbuterol Fig11)

Label for Levalbuterol Inhalation Solution, USP 0.31 mg/3 mL sterile unit-dose vials. The product is for oral inhalation only and comes in a package of 5 vials of 3 mL each. Manufactured by Luoxin Aurovitas Pharma (Chengdu) Co., Ltd. and distributed by Aurobindo Pharma USA, Inc. The label includes storage instructions, warnings, and the NDC 81894-101-05 with a barcode at the bottom.*

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Levalbuterol-carton-0.31 (Levalbuterol Fig12)

Packaging label for Levalbuterol Inhalation Solution, USP 0.31 mg/3 mL, a respiratory inhalation solution. The box contains 25 sterile unit-dose vials of 3 mL each. Labeler information includes Luoxin Aurovitas Pharma (Chengdu) Co., Ltd., and distributor Aurobindo Pharma USA, Inc. The label highlights storage instructions, dosage potency, and contains a barcode and NDC 81894-101-25.*

FDA Label Image

Levalbuterol-pouch-0.63mg (Levalbuterol Fig13)

Label for Levalbuterol Inhalation Solution, USP 0.63 mg/3 mL by Luoxin Aurovitas Pharma (Chengdu) Co., Ltd. The label indicates this is a prescription solution for oral inhalation, presented as 5 sterile unit-dose vials of 3 mL each. Distributed by Aurobindo Pharma USA, Inc., the label includes storage instructions and a barcode.*

FDA Label Image

Levalbuterol-carton-0.63 (Levalbuterol Fig14)

Levalbuterol Inhalation Solution USP 0.63 mg/3 mL sterile unit-dose vials packaging label. The label displays Rx Only, strength 0.63 mg/3 mL, and packaging of 25 x 3 mL sterile unit-dose vials. Distributed by Aurobindo Pharma USA, Inc. and manufactured by Luoxin Aurovitas Pharma (Chengdu) Co., Ltd. The label includes storage instructions and a barcode.*

FDA Label Image

Levalbuterol-pouch-1.25mg (Levalbuterol Fig15)

Label for Levalbuterol Inhalation Solution, USP, 1.25 mg/3 mL sterile unit-dose vials. The label indicates oral inhalation use, with five 3 mL vials per package. Distributed by Aurobindo Pharma USA, Inc. and manufactured by Luoxin Aurovitas Pharma (Chengdu) Co., Ltd. Storage instructions specify protection from light at 20-25°C. The label includes a barcode and usage warnings.*

FDA Label Image

Levalbuterol-carton-1.25mg (Levalbuterol Fig16)

Packaging label for Levalbuterol Inhalation Solution, USP 1.25 mg/3 mL by Luoxin Aurovitas Pharma (Chengdu) Co., Ltd. The carton displays dosage form as sterile unit-dose vials, with a package size of 25 x 3 mL. It includes storage instructions, distributor details (Aurobindo Pharma USA, Inc.), and the National Drug Code (NDC 81894-103-25). Label indicates Rx only and states "For Oral Inhalation Only."*

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Figure 2 (Levalbuterol Fig2)

Line graph depicting the mean percent change from baseline FEV1 over 8 hours on Day 29 in adults and adolescents aged 12 years and older. The graph compares different treatments: Levalbuterol 1.25 mg/3mL, Levalbuterol 0.63 mg/3mL, Racemic albuterol 2.5 mg/3mL, and placebo (PBO). The y-axis shows mean change in FEV1 (%), and the x-axis shows time in hours.*

FDA Label Image

Figure 3 (Levalbuterol Fig3)

A line chart showing the mean percent change from baseline FEV1 on Day 1 in children aged 6 to 11 years. The x-axis represents time in hours (0 to 4), and the y-axis shows mean change in FEV1 percentage (-5% to 30%). The graph compares five groups: Levalbuterol 0.63 mg, Levalbuterol 0.31 mg, Racemic albuterol 2.5 mg and 1.25 mg, and placebo, illustrating changes over time in lung function.*

FDA Label Image

Figure 4 (Levalbuterol Fig4)

Line chart titled 'Mean Percent Change from Baseline FEV1 on Day 21, Children 6 to 11 Years of Age' depicting percent change in FEV1 over 4 hours. The chart compares different treatment groups labeled Lev 0.63 mg, Lev 0.31 mg, Rac 2.5 mg, Rac 1.25 mg, and placebo with respective sample sizes, showing variations in mean FEV1 percentage change over time.*

FDA Label Image

Figure A (Levalbuterol Fig5)

An illustration labeled as Figure A depicting a single vial or ampule, typically used for holding a liquid solution. The drawing shows the vial shape with a narrow neck and a wider body, commonly used for respiratory inhalation solutions such as Levalbuterol.*

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Figure B (Levalbuterol Fig6)

An instructional illustration showing a hand gripping a vial with the other hand pulling the cap off by twisting upward, demonstrating how to open the vial for use.*

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Figure C (Levalbuterol Fig7)

An instructional illustration showing a hand holding and inserting a vial into a labeled reservoir component of a device, depicting proper placement for use. The vial and reservoir are clearly labeled in the diagram.*

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Figure D.1, D.2 (Levalbuterol Fig8)

Illustrative diagrams showing components of a respiratory inhalation solution setup. Figure D.1 depicts a mouthpiece connected to a reservoir chamber. Figure D.2 shows a face mask attached to the reservoir chamber, indicating two ways the inhalation solution can be administered.*

FDA Label Image

Figure E (Levalbuterol Fig9)

An illustration labeled as Figure E showing the connection of nebulizer tubing to a compressor device. The compressor is depicted with a dial, a display, and the tubing is inserted into an outlet labeled 'Nebulizer Tubing.'*

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Levalbuterol Hydrochloride Chemical Structure (Levalbuterol Str)

Chemical structure diagram of Levalbuterol hydrochloride showing its molecular framework with hydroxyl groups, amine, and hydrochloride components.*

* 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.