Cleviprex Emulsion
Product Images NDC 18124-011

15 FDA label images from Fresenius Kabi Austria Gmbh · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Cleviprex (NDC 18124-011). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Fresenius Kabi Austria Gmbh, 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

Clevidipine Structure And Formula (Cleviprex Figure 1)

Clevidipine Structure And Formula (Cleviprex Figure 1)
Chemical structure of clevidipine, the active ingredient in Cleviprex. The structure shows the molecular formula C21H23Cl2NO6 with detailed representation of atoms and bonds.*
FDA Label Image

Package Label (Principal Display Panel)

Package Label (Principal Display Panel)
Label for Cleviprex (clevidipine) injectable emulsion, 0.5 mg/mL strength, in a 100 mL single-use vial. The label includes usage instructions, storage information, and warnings to invert the vial gently several times before use. Labeler is Fresenius Kabi Austria GmbH.*
FDA Label Image

Package Label (Principal Display Panel)

Package Label (Principal Display Panel)
Cleviprex (clevidipine) injectable emulsion 50 mg/100 mL (0.5 mg/mL) packaging label. The label includes drug contents, storage instructions, and warnings. It specifies that Cleviprex is for intravenous use, single use vial, and is manufactured by The Medicines Company, distributed by Fresenius Kabi Austria GmbH. The label highlights important safety information including contamination risks and disposal instructions.*
FDA Label Image

Package Label (Principal Display Panel)

Package Label (Principal Display Panel)
Cleviprex 0.5 mg/mL (clevidipine) injectable emulsion, 50 mg per 100 mL vial. The label indicates the product is for intravenous use only, with 10 single-use vials per package. Labeler is Fresenius Kabi Austria GmbH, marketed by The Medicines Company. Storage instructions specify refrigeration at 2-8°C (36-46°F).*
FDA Label Image

Package Label (Principal Display Panel)

Package Label (Principal Display Panel)
Label for Cleviprex (clevidipine) injectable emulsion, 0.5 mg/mL strength, presented in a 250 mL container with total 125 mg clevidipine. The label shows product name, strength, and usage instructions including storage and handling guidelines. Labeler is Fresenius Kabi Austria GmbH. Includes barcode and lot/expiration date fields.*
FDA Label Image

Package Label (Principal Display Panel)

Package Label (Principal Display Panel)
Cleviprex (clevidipine) injectable emulsion box label showing 125 mg / 250 mL (0.5 mg/mL) strength. The label details intravenous emulsion dosage form, with storage instructions, contents including active ingredient clevidipine and other components, warnings, and contraindications. Labeler is Fresenius Kabi Austria GmbH. The label emphasizes single-use vial and protective storage conditions.*
FDA Label Image

Package Label (Principal Display Panel)

Package Label (Principal Display Panel)
Packaging label for Cleviprex injectable emulsion 0.5 mg/mL (125 mg/250 mL), a human prescription drug for intravenous use. The label indicates the product contains 4 single-use vials and is labeled for prescription use only. It is manufactured by Fresenius Kabi Austria GmbH and includes storage instructions to keep vials refrigerated at 2-8°C (36-46°F).*
FDA Label Image

Figure 1. Mean Change In Systolic Blood Pressure (mmhg) During 30-minute Infusion, Escape-1 (preoperative) (Cleviprex Figure 2)

Figure 1. Mean Change In Systolic Blood Pressure (mmhg) During 30-minute Infusion, Escape-1 (preoperative) (Cleviprex Figure 2)
A line graph illustrating the mean change from baseline in systolic blood pressure (mmHg) over 30 minutes comparing clevidipine to placebo. The x-axis represents time in minutes, and the y-axis shows the change in systolic blood pressure. The graph shows a significant decrease in blood pressure with clevidipine compared to placebo over time.*
FDA Label Image

Figure 2. Mean Change In Systolic Blood Pressure (mmhg) During 30-minute Infusion, Escape-2 (postoperative) (Cleviprex Figure 3)

Figure 2.  Mean Change In Systolic Blood Pressure (mmhg) During 30-minute Infusion, Escape-2 (postoperative) (Cleviprex Figure 3)
A line graph showing mean change from baseline in systolic blood pressure (mmHg) over 30 minutes for clevidipine versus placebo. The graph depicts a steady decrease in blood pressure with clevidipine, while placebo shows minimal change. A note indicates patient dropout affecting placebo data during the infusion period.*
FDA Label Image

Figure 3. Mean Change In Heart Rate (bpm) During 30-minute Infusion, Escape-1 (preoperative) (Cleviprex Figure 4)

Figure 3.  Mean Change In Heart Rate (bpm) During 30-minute Infusion, Escape-1 (preoperative) (Cleviprex Figure 4)
A line graph depicting mean change from baseline heart rate (beats per minute) over 30 minutes. The graph compares clevidipine and placebo treatments, with clevidipine showing an increase and placebo a decrease in heart rate over time.*
FDA Label Image

Figure 4. Mean Change In Heart Rate (bpm) During 30-minute Infusion, Escape-2 (postoperative) (Cleviprex Figure 5)

Figure 4.  Mean Change In Heart Rate (bpm) During 30-minute Infusion, Escape-2 (postoperative) (Cleviprex Figure 5)
A line graph showing mean change from baseline heart rate (beats per minute) over time (minutes) comparing clevidipine and placebo. The graph plots heart rate changes for 30 minutes, indicating different trends for clevidipine and placebo groups.*
FDA Label Image

Figure 5. Mean Percent Change In Sbp (%) During The First 30 Minutes Of Infusion, Velocity (severe Hypertension) (Cleviprex Figure 6)

Figure 5.  Mean Percent Change In Sbp (%) During The First 30 Minutes Of Infusion, Velocity (severe Hypertension) (Cleviprex Figure 6)
A line graph showing the mean percent change from baseline systolic blood pressure (%) over time (minutes) after administration of clevidipine. The graph depicts a decreasing trend in systolic blood pressure from 0 to 30 minutes, with data points connected by a line labeled "Clevidipine." The y-axis ranges from 0% to -25%, and the x-axis covers 0 to 30 minutes in increments of 5.*
FDA Label Image

Package Label (Principal Display Panel)

Package Label (Principal Display Panel)
Cleviprex (clevidipine) injectable emulsion label for 25 mg in 50 mL vial containing 0.5 mg/mL strength. The label includes directions such as 'Invert Vial Gently Several Times Before Use' and indicates it is for intravenous use only. It is labeled by Fresenius Kabi Austria GmbH with storage instructions and barcodes visible.*
FDA Label Image

Package Label (Principal Display Panel)

Package Label (Principal Display Panel)
Packaging label for Cleviprex (clevidipine) injectable emulsion 25 mg/50 mL (0.5 mg/mL) by Fresenius Kabi Austria GmbH. The label shows dosage form as intravenous emulsion, single-use vial, with storage instructions and warnings about microbial growth and usage period. The label includes branding for The Medicines Company and barcode details.*
FDA Label Image

Package Label (Principal Display Panel)

Package Label (Principal Display Panel)
Packaging label for Cleviprex injectable emulsion containing clevidipine at 0.5 mg/mL concentration. The label indicates a strength of 25 mg per 50 mL vial, with 10 single-use vials per package. It specifies intravenous use, prescription only, and labeler Fresenius Kabi Austria GmbH. The label also includes storage instructions and barcode.*

* 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.