Chemical Structure (Wakix 01)
Wakix Tablet, Film Coated
Product Images NDC 72028-045
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Wakix (NDC 72028-045). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Harmony Biosciences, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Product Images & Figures Index
Figure 1 (Wakix 02)
This appears to be a table showing the impact of hepatic impairment (mild and moderate) on the AUC (area under the concentration-time curve) and fold change, along with their 90% confidence intervals, in relation to a reference healthy volunteer. The term "Crax" is not clear in this context and may be a misinterpretation of another word.*
Figure 2 (Wakix 03)
Figure 3 (Wakix 04)
This text appears to show statistical information about "Fold Change and 90% Confidence Intervals" related to "Relative change to the reference (Extensive Metabolizers)". However, the text is incomplete and therefore it is not possible to provide a useful description.*
Figure 4 (Wakix 05)
This text appears to be a list of medications classified according to their inhibitory or inducing effects on certain enzymes in the body, such as CYP2D6 and CYP3A. It also mentions fold change and confidence intervals related to these medications, possibly indicating their potency or efficacy. Some of the listed medications include paroxetine, iraconazole, ritampicin, modatini, and sodium oxybate.*
Figure 5 (Wakix 06)
Figure 6 (Wakix 07)
4.45 mg Bottle Label (Wakix 08)
This is a description of the medication Wakix in tablet form, containing either 4.45mg of pitolisantas or 5mg of pitolisant hydrochloride. The dosage and administration instructions can be found in the package insert. It is to be stored at room temperature between 20°C to 25°C. It is manufactured for Harmony Biosciences, LLC. The given NDC number is 72028-045-03 with a product number of 70014523.*
4.45 mg Carton Label (Wakix 09)
WAKIX is a medication that comes in a container of 30 tablets and is made in France. Each tablet contains 4.45 mg of pitolisant hydrochloride. It is manufactured for Harmony Biosciences, LLC based in Plymouth Meeting, PA. The Harmony Biosciences name and logo are registered trademarks.*
17.8 mg Bottle Label (Wakix 10)
This is a description of a medication identified by the National Drug Code (NDC) 72028-178-03. The medication consists of tablets that contain 17.8 mg of pitolisantas and 20 mg of pitolisant hydrochloride, produced by Harmony Biosciences, LLC. The dosage and administration details are available in the package insert. The medication needs to be stored in a temperature range of 20°C to 25°C (68°F to 77°F).*
17.8 mg Carton Label (Wakix 11)
Wakix is a brand of pitolisant tablets that contain 17.8 mg of pitolisant hydrochloride. The dosage instructions for pitolisant are unknown, but users should see the package insert for this information. Every package contains 30 tablets, and the tablets should be stored at a temperature between 20°C to 25°C (68°F to 77°F). Harmony Biosciences, LLC manufactures Pitolisant tablets for Bioprojet Europe, Ltd. Each tablet container has a unique component code (70015547) that may be used for serialization and Datamatrix coding purposes.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
