Wakix Tablet, Film Coated
Product Images NDC 72028-045

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.

FDA Label Image

Chemical Structure (Wakix 01)

Chemical structure of pitolisant hydrochloride, showing the arrangement of atoms including a chlorophenyl group, an ether linkage, a piperidine ring, and associated HCl component.*

FDA Label Image

Figure 1 (Wakix 02)

A fold change chart with 90% confidence intervals showing pharmacokinetic parameters Cmax and AUCinf in subjects with mild and moderate hepatic impairment compared to healthy volunteers as reference for the drug Wakix (pitolisant hydrochloride).*

FDA Label Image

Figure 2 (Wakix 03)

A chart titled 'Fold Change and 90% Confidence Intervals' illustrating the change relative to healthy volunteers in Cmax and AUCinf values across three levels of renal impairment: mild, moderate, and severe. The x-axis shows the change relative to reference on a scale from 0.5 to 4.0, with data points and confidence intervals for each category plotted accordingly.*

FDA Label Image

Figure 3 (Wakix 04)

A chart depicting fold change and 90% confidence intervals for Cmax and AUC0-24 in poor metabolizers relative to extensive metabolizers for Wakix (pitolisant hydrochloride). The x-axis represents change relative to reference on a logarithmic scale from 0.5 to 4.0, showing increased exposure in poor metabolizers.*

FDA Label Image

Figure 4 (Wakix 05)

A chart showing fold changes and 90% confidence intervals in pharmacokinetic parameters (Cmax and AUCinf) for Wakix (pitolisant hydrochloride) when coadministered with various strong CYP2D6 and CYP3A4 inhibitors, inducers, and other medications such as paroxetine, itraconazole, rifampicin, modafinil, and sodium oxybate. The x-axis represents change relative to reference without interacting drug.*

FDA Label Image

Figure 5 (Wakix 06)

A chart showing fold change and 90% confidence intervals for various sensitive CYP3A4 and CYP2B6 substrate medications and other drugs. It plots Cmax and AUCinf or AUC0-24 values for midazolam, bupropion, modafinil, and sodium oxybate, illustrating changes relative to a reference without the interacting drug along a horizontal axis ranging from 0.5 to 4.0.*

FDA Label Image

Figure 6 (Wakix 07)

A line graph comparing the ESS Score (SEM) over 8 weeks for two groups: Placebo and Pitolisant. The x-axis represents time from Baseline to Week 8, and the y-axis measures ESS Score ranging from 0 to 24. The graph shows a decreasing trend in ESS Scores, with the Pitolisant group generally having lower scores than the Placebo group throughout the study period.*

FDA Label Image

4.45 mg Bottle Label (Wakix 08)

Label for Wakix 4.45 mg film-coated tablets containing pitolisant hydrochloride. The label states 30 tablets per container and includes storage instructions at 20°C to 25°C (68°F to 77°F). Manufactured for Harmony Biosciences, LLC, Plymouth Meeting, PA. The label includes dosage information and a barcode.*

FDA Label Image

4.45 mg Carton Label (Wakix 09)

Packaging label for Wakix pitolisant tablets 4.45 mg, a prescription oral film-coated tablet. The label indicates 30 tablets per package manufactured for Harmony Biosciences, LLC, Plymouth Meeting, PA. The label includes storage instructions and a barcode, with the drug identified as pitolisant hydrochloride.*

FDA Label Image

17.8 mg Bottle Label (Wakix 10)

Wakix 17.8 mg film-coated tablets label showing product name, strength, quantity (30 tablets), and active ingredient pitolisant hydrochloride. The label includes dosage storage instructions (20°C to 25°C) and manufacturer Harmony Biosciences, LLC, Plymouth Meeting, PA. Markings include NDC 72028-178-03 and a barcode.*

FDA Label Image

17.8 mg Carton Label (Wakix 11)

The packaging label for Wakix pitolisant tablets, 17.8 mg, film-coated oral tablets. The label shows the product name, strength, count of 30 tablets, and the NDC number 72028-178-03. It includes manufacturer information for Harmony Biosciences, LLC, Plymouth Meeting, PA. Storage instructions and dosage administration notes are also present, along with a barcode on the side panel.*

* 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.