Quviviq Tablet, Film Coated
Product Images NDC 80491-7825

7 FDA label images from Idorsia Pharmaceuticals Ltd · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Quviviq (NDC 80491-7825). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Idorsia Pharmaceuticals 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

Chemical Structure (Quviviq 01)

Chemical Structure (Quviviq 01)
Chemical structure of daridorexant, the active ingredient in QUVIVIQ. The diagram depicts the molecular structure with specific functional groups, rings, and atoms as part of the daridorexant compound.*
FDA Label Image

Figure 1 (Quviviq 02)

Figure 1 (Quviviq 02)
A forest plot chart showing the mean effect and 90% confidence intervals for AUC and Cmax in subjects with mild hepatic impairment, moderate hepatic impairment, and severe renal impairment, relative to reference values. The horizontal axis indicates the change relative to reference from 0.0 to 3.0, with data points plotted as circles (AUC) and squares (Cmax) with error bars.*
FDA Label Image

Figure 2 (Quviviq 03)

Figure 2 (Quviviq 03)
A forest plot showing the mean effect and 90% confidence intervals for the interaction of different compounds with Daridorexant. The chart compares mild and moderate CYP3A4 inhibitors and inducers, gastric pH modifiers, alcohol, and SSRI effects on AUC and Cmax, displayed as change relative to reference with data points and error bars for each compound.*
FDA Label Image

Figure 3 (Quviviq 04)

Figure 3 (Quviviq 04)
This chart illustrates the mean effect and 90% confidence interval of various interacting compounds on pharmacokinetic parameters (AUC and Cmax) relative to reference values. It includes CYP3A4 substrates (Midazolam with single-dose and steady-state daridorexant), BCRP substrate (Rosuvastatin), and SSRI (Citalopram), showing quantitative changes with associated confidence intervals on a horizontal axis from 0 to 2.*
FDA Label Image

Figure 4 (Quviviq 05)

Figure 4 (Quviviq 05)
Line graph depicting change from baseline in minutes over a 12-week period comparing QUVIVIQ 50 mg, QUVIVIQ 25 mg, and placebo. The vertical axis shows change in minutes, and the horizontal axis shows time in weeks. The graph illustrates increasing change from baseline for both QUVIVIQ doses compared to placebo over time.*
FDA Label Image

Principal Display Panel (25 mg Tablet Bottle Carton)

Principal Display Panel (25 mg Tablet Bottle Carton)
Packaging label for QUVIVIQ (daridorexant) tablets, 25 mg strength, film-coated oral tablets. The label indicates the package contains 30 tablets and is for prescription use only. It includes storage instructions, manufacturer (Idorsia Pharmaceuticals Ltd), and distributor information (Idorsia Pharmaceuticals US Inc). The label features barcodes and dosage details for the 25 mg strength tablets.*
FDA Label Image

Principal Display Panel (50 mg Tablet Bottle Carton)

Principal Display Panel (50 mg Tablet Bottle Carton)
Packaging label for QUVIVIQ 50 mg tablets, film-coated oral tablets containing daridorexant. The label indicates 30 tablets per package and notes the product is prescription-only (Rx only). Distributed by Idorsia Pharmaceuticals US Inc. The label includes storage instructions and barcode details.*

* 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.