Rezenopy
Product Images NDC 43674-004

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Rezenopy (NDC 43674-004). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Summit Biosciences 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.

FDA Label Image

Structure (Image 01)

Chemical structure diagram showing the molecular formula of the active ingredient in Rezenopy, including hydrochloride and dihydrate components as indicated by .HCl .2H2O.*

FDA Label Image

Figure 1 (Image 02)

A pharmacokinetic graph comparing naloxone plasma concentrations over 30 minutes for Rezenopy nasal spray 10 mg, 0.4 mg intramuscular injection, and 2 mg intravenous injection. The y-axis shows naloxone concentration in ng/mL, and the x-axis shows time in minutes. Each form demonstrates distinct plasma concentration curves with error bars representing variability.*

FDA Label Image

Figure 2 (Image 03)

A line graph showing Naloxone plasma concentrations (ng/mL) over time (hours) comparing Rezenopy nasal spray 10 mg, 0.4 mg intramuscular injection, and 2 mg intravenous injection. The graph illustrates concentration trends and variability with error bars over an 8-hour period.*

FDA Label Image

Ifu Figure A (Image 04)

An instructional diagram labeled Figure A showing a device component with parts identified as 'Nozzle' and 'Plunger.' The image highlights these two main elements of the device, presented in a clear black-and-white line drawing format.*

FDA Label Image

Ifu Figure B-3 (Image 05)

An illustration labeled Figure B depicts a person lying on their side with one arm extended forward and the other arm bent, resting near their head. The person appears to be demonstrating a body position or posture, with eyes closed and a relaxed expression.*

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Ifu Figure C-3 (Image 06)

An instructional illustration labeled Figure C showing a person lying on their back on a flat surface with their head tilted backward. The image appears to demonstrate a head movement or positioning technique, possibly related to medical or procedural guidance.*

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Ifu Figure D (Image 07)

An instructional illustration showing two hands opening a blister pack. The first hand tears a foil backing, and the second hand pushes a tablet or capsule upward through the blister to remove it, labeled as Figure D.*

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Ifu Figure E (Image 08)

An instructional illustration labeled 'Figure E' showing a hand holding a device, positioned from the front view, with a thumb pressing down on a white horizontal bar or button. The device appears to be designed for manual operation or application.*

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Ifu Figure F (Image 09)

An instructional illustration showing a person lying down with their head tilted backward and an arrow indicating the motion of tilting the head up while supporting the neck with a hand placed under the jaw. Labeled as Figure F.*

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Ifu Figure G (Image 10)

Illustration showing a person administering nasal spray to another individual lying down. The spray device is positioned near the nostril, with the head tilted back, demonstrating the proper nasal spray technique. Labeled as Figure G.*

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Ifu Figure H (Image 11)

An illustration showing a hand pinching the skin, likely demonstrating a subcutaneous injection technique, with an arrow indicating the direction of needle insertion. The image is labeled as Figure H.*

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Ifu Figure I (Image 12)

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Ifu Figure J (Image 13)

An instructional diagram showing a person lying on their side with one hand supporting their head and bent knees preventing body rollover. A clock icon indicates a 2 to 3 minutes duration with the instruction to put the person in a recovery position and watch.*

FDA Label Image

Ifu Figure K (Image 14)

An instructional diagram showing a hand holding a nasal spray device directed into one nostril, with an arrow pointing upwards and the text 'Use Other Nostril' indicating the use of the alternative nostril for administration.*

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Ifu Figure L (Image 15)

An illustration showing a hand discarding a single tablet into a container labeled 'Trash.' The image is labeled as Figure L and visually instructs the disposal of medication by placing it into the trash bin.*

FDA Label Image

Principal Display Panel (Carton)

The image is a carton label for Rezenopy Nasal Spray, containing 10 mg of Naloxone Hydrochloride. It is labeled for nasal use only, providing 2 nasal spray devices with one dose each. The label includes storage instructions, warnings, inactive ingredients, and manufacturer details from Summit Biosciences Inc, Lexington, KY.*

* 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.