Spravato Solution
Product Images NDC 50458-028

Product Visual Gallery

This gallery contains 37 technical images submitted to the FDA as part of the official labeling for Spravato (NDC 50458-028). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Janssen 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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Figure (Spravato 01)

Instructional diagram of the Spravato nasal spray device showing labeled parts: tip, nose rest, indicator, finger rest, and plunger. The indicator section explains spray status with green dots: two dots mean device full with 0 mg delivered, one dot means one spray delivered, and no dots means device empty after two sprays delivering 28 mg of esketamine.*

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Figure (Spravato 02)

Instructional diagram titled 'Step 1 Get ready' for Spravato (Esketamine Hydrochloride nasal solution). It advises to instruct the patient to blow their nose before the first device only and to confirm the required number of devices, noting that 56 mg equals 2 devices and 84 mg equals 3 devices.*

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Figure (Spravato 03)

Instructional illustration for Step 2 of preparing the Spravato nasal spray device. It shows a healthcare professional removing the device from blister packaging, checking the expiration date, and instructions not to prime the device. The indicator with two green dots is highlighted as a check before handing the device to the patient.*

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Figure (Spravato 04)

An instructional illustration showing Step 3 for preparing a patient for nasal administration of medication. It features two panels: one demonstrating how to hold the nasal spray device with the thumb supporting the plunger without pressing it, and another showing the patient reclining their head at about a 45-degree angle to keep medication inside the nose.*

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Figure (Spravato 05)

Illustration showing Step 4 of a usage instruction, directing the patient to spray once into each nostril. The step number and instruction text are highlighted with contrasting background colors.*

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Figure (Spravato 06)

Instructional illustrations showing how to administer Spravato (Esketamine Hydrochloride) nasal spray. Steps include inserting the spray tip into the first nostril with the nose rest on the skin between nostrils, closing the opposite nostril and breathing in while spraying, gently sniffing to keep the medication inside, then switching to the second nostril to repeat the spray delivery.*

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Figure (Spravato 07)

An instructional diagram from Step 5 of a process for Spravato nasal spray administration. It shows actions for healthcare professionals to confirm delivery, including checking the device indicator for green dots, instructing the patient to rest in a semi-reclined position for 5 minutes after administration, and advising not to blow the nose. It also emphasizes repeating prior steps for the next device and ensuring a 5-minute wait after each device to allow medication absorption.*

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Figure (Spravato 08)

Text panel providing disposal instructions for used devices of a Schedule III drug product, advising compliance with applicable federal, state, and local regulations.*

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Chemical Structure (Spravato 09)

Chemical structure of Esketamine Hydrochloride showing a bicyclic ring system with a chlorine substituent and an amine methyl group, labeled as the hydrochloride salt.*

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Figure 1 (Spravato 10)

A chart presenting pharmacokinetic (PK) fold change and 90% confidence intervals (CI) for Cmax and AUC across various population subgroups including age, race, hepatic and renal impairment, and allergic rhinitis status. The horizontal axis indicates change relative to reference values, showing comparisons of drug exposure metrics in these groups.*

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Figure 2 (Spravato 11)

A chart showing the pharmacokinetic fold change and 90% confidence intervals of esketamine exposure (Cmax and AUC) when coadministered with various interacting drugs including cytochrome P450 inducers and inhibitors, nasal corticosteroids, and nasal decongestants. The x-axis represents the fold change relative to reference with values from 0.5 to 1.5.*

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Figure 3 (Spravato 12)

A chart showing fold change and 90% confidence intervals for pharmacokinetic parameters (Cmax and AUC) of Bupropion and Midazolam, substrates of hepatic enzymes CYP2B6 and CYP3A respectively. The graph illustrates changes relative to a reference value of 1.0 after administration of intranasal esketamine (84 mg). A note below explains study conditions involving dosing schedules and assessment of cytochrome P450 induction potential.*

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Figure 4 (Spravato 13)

A line chart comparing change from baseline over 28 days between Spravato (Esketamine Hydrochloride) plus oral antidepressant and placebo nasal spray plus oral antidepressant. The graph shows two trend lines with the Spravato group marked by squares and the placebo group marked by circles, demonstrating decreasing values over time with Spravato showing a greater reduction.*

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Figure 5 (Spravato 14)

A Kaplan-Meier survival curve chart comparing the percent of patients with a relapse over weeks since entering the maintenance phase, for Placebo Nasal Spray + Oral AD versus SPRAVATO + Oral AD. The chart includes data on the number of subjects at risk at intervals and shows lower relapse rates in the SPRAVATO + Oral AD group compared to Placebo Nasal Spray + Oral AD.*

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Figure 6 (Spravato 15)

A Kaplan-Meier curve chart showing the percent of patients with a relapse over time in weeks since entering the maintenance phase, comparing Placebo Nasal Spray + Oral AD versus SPRAVATO + Oral AD. The graph includes the number of subjects at risk for each time point along the x-axis.*

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Figure 7 (Spravato 15a)

A line graph comparing change from baseline over time in two groups: SPRAVATO + SOC and Placebo + SOC. The x-axis represents time points from baseline to Day 25, and the y-axis shows the change from baseline values. Both groups show a decreasing trend, with SPRAVATO + SOC consistently demonstrating a greater decrease compared to Placebo + SOC.*

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Figure (Spravato 16)

Spravato 28 mg/0.2 mL nasal solution spray device showing a white and blue plastic applicator with a white cap. The device includes a nasal spray tip and a blue flange with a green indicator button on the front. Labeler Janssen Pharmaceuticals, Inc.*

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Figure (Spravato 17)

Spravato 28 mg/0.2 mL nasal solution box by Janssen Pharmaceuticals, Inc. The packaging is white with a blue control panel featuring an ON/OFF button and numeric display, indicating the product's use with a dosing device. The brand and generic names appear on the box alongside dosage strength and route.*

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Figure (Spravato 18)

Illustration of a nasal spray device for Spravato (Esketamine Hydrochloride) 28 mg/0.2 mL solution, showing labeled parts including the tip, nose rest, indicator, finger rest, and plunger. Accompanying indicator guide explains the device spray status with two green dots meaning device is full (0 mg delivered), one green dot indicating one spray delivered, and no green dots indicating both sprays (28 mg) delivered and the device is empty.*

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Figure (Spravato 19)

An instructional graphic titled 'Step 1 Get ready' showing a step indicator with the number 1 on a black background, followed by an orange section containing the text 'Get ready.' This is the first step in a multi-step process likely related to the use of Spravato nasal solution.*

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Figure (Spravato 20)

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Figure (Spravato 21)

An illustration showing three nasal spray devices of different sizes or amounts. Each device features a bottle with a nozzle and protective cap designed for nasal administration of medication, likely representing different dosage presentations of a nasal spray solution.*

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Figure (Spravato 22)

An instructional diagram showing dosage equivalencies for Spravato (Esketamine Hydrochloride) nasal solution. It specifies that 56 mg corresponds to 2 devices, and 84 mg corresponds to 3 devices.*

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Figure (Spravato 23)

An instructional illustration showing Step 2, labeled 'Prepare device,' depicting hands holding and preparing a small medical device, likely related to nasal administration.*

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Figure (Spravato 24)

An instructional illustration showing a nasal spray device with a blue body and a single green button or indicator in the center. The device nozzle is at the top, designed for nasal delivery of medication.*

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Figure (Spravato 25)

Instructional illustration labeled Step 3, Prepare patient, showing a hand holding a nasal spray device, likely demonstrating preparation before administration of the spray.*

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Figure (Spravato 26)

An instructional illustration showing a person's head tilted back at about a 45-degree angle, indicated by an arrow and text. This likely demonstrates the proper positioning for nasal administration of the solution.*

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Figure (Spravato 27)

Instructional illustration showing step 4 for Spravato nasal spray usage. It depicts a patient spraying once into each nostril, with a hand holding the nasal spray device positioned near the nose, indicating the correct angle for administration.*

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Figure (Spravato 28)

An instructional diagram showing a hand holding a nasal spray device positioned near a person's nostril, while the other hand gently touches the person's nose, indicating administration of nasal spray medication.*

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Figure (Spravato 29)

An instructional diagram showing the nasal route of administration with a spray aimed into the nostril, indicated by arrows depicting the direction of spray delivery and airflow through the nose.*

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Figure (Spravato 30)

An instructional diagram showing a nasal spray administration technique. It depicts a hand holding a nasal spray device inserted into a nostril with a dotted line indicating the proper angle for spray delivery.*

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Figure (Spravato 31)

An instructional illustration labeled Step 5, titled 'Confirm delivery and rest.' It shows a schematic drawing of a nasal spray bottle with a nozzle, likely depicting the final step in using the spray device for nasal administration.*

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Figure (Spravato 32)

An instructional illustration showing a person resting with their head tilted back. A clock icon nearby indicates a 5-minute rest period. The image suggests a step or guideline involving resting for five minutes, likely related to nasal administration of Spravato (Esketamine Hydrochloride) solution.*

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Figure (Spravato 33)

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Figure (Spravato 34)

An instructional diagram illustrating dosing instructions for Spravato nasal spray devices for two dose levels: 56 mg and 84 mg. It shows device icons with the number of spray actuations (five sprays per device) corresponding to each dose, indicating the use of one device for 56 mg and two devices for 84 mg dosing.*

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Figure (Spravato 35)

A medication instruction panel for Spravato nasal solution emphasizing the importance of waiting 5 minutes after each device use for medication absorption. It also includes disposal instructions for used devices, following Schedule III drug product and applicable regulations.*

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Principal Display Panel (Two 28 mg Device Blister Pack Kit)

Packaging label for Spravato (esketamine) nasal spray 56 mg Dose Kit by Janssen Pharmaceuticals, Inc. The kit contains two nasal spray devices, each delivering 28 mg of esketamine, for a total of 56 mg per dose. The label specifies intranasal use only and includes storage instructions and a 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.