Pitolisant Tablet, Film Coated
Product Images NDC 70748-387

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Pitolisant (NDC 70748-387). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Lupin 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.

FDA Label Image

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Chemical structure of pitolisant hydrochloride, the active ingredient in PITOLISANT. The structure features a chlorophenyl group linked via an ether bond to a piperidine ring with an appended nitrogen atom, annotated with the hydrochloride salt designation (.HCl).*

FDA Label Image

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A chart depicting fold changes and 90% confidence intervals for pharmacokinetic parameters Cmax and AUCinf of pitolisant in subjects with mild and moderate hepatic impairment compared to healthy volunteers. The x-axis shows change relative to reference (healthy volunteer), ranging from 0.5 to over 4, with plotted points and confidence intervals for each parameter and impairment level on the y-axis.*

FDA Label Image

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A forest plot chart showing fold change and 90% confidence intervals for Cmax and AUCinf relative to a healthy volunteer reference in subjects with mild, moderate, and severe renal impairment. The x-axis represents change relative to healthy volunteers ranging from 0.5 to 4, with data points and confidence intervals depicted for each impairment category and pharmacokinetic parameter.*

FDA Label Image

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This chart shows the fold change and 90% confidence intervals for the pharmacokinetic parameters Cmax and AUCinf of pitolisant in the presence of various interacting drugs. It compares changes relative to the reference (without interacting drug) for strong CYP2D6 inhibitors (paroxetine), strong CYP3A4 inhibitors (itraconazole), strong CYP3A4 inducers (rifampicin), and other medications including modafinil and sodium oxybate.*

FDA Label Image

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A chart showing fold change and 90% confidence intervals for various medications, including midazolam (CYP3A4 substrate), bupropion (CYP2B6 substrate), modafinil, and sodium oxybate. The chart compares the change in Cmax and AUC values relative to a reference without interacting drug, with plotted error bars and numerical confidence intervals.*

FDA Label Image

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A line graph comparing ESS scores over an 8-week period between placebo and Pitolisant groups. The x-axis represents time from baseline to week 8, and the y-axis shows ESS score (SEM). Data points show Pitolisant scores decreasing steadily, while placebo scores remain higher with less decline over time.*

FDA Label Image

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The image shows the front of a carton box for PITOLISANT 17.8 mg film-coated tablets. The label displays the brand name PITOLISANT in large letters, identifies the active ingredient pitolisant, and states the strength of 17.8 mg per tablet. The dosage form is oral tablets. The labeler Lupin Pharmaceuticals, Inc. is also indicated on the box.*

FDA Label Image

Container Label 4.45 (E46eef01 594a 49ca A453 0b680e4ee730 07)

Label for Pitolisant Tablets 4.45 mg, film-coated oral tablets by Lupin Pharmaceuticals, Inc. The label indicates 30 tablets per package, and includes NDC 70748-386-01. Storage instructions and manufacturer information for Lupin Limited, India, are also visible, along with a barcode and space designated for lot and expiration details.*

FDA Label Image

4.45 Carton (E46eef01 594a 49ca A453 0b680e4ee730 08)

Packaging label for Pitolisant Tablets 4.45 mg in a 30-tablet bottle. The label shows the NDC 70748-386-01 and indicates the product is manufactured for Lupin Pharmaceuticals, Inc. and Lupin Limited, India. It notes storage instructions and contains prescription-only information with Lupin branding.*

FDA Label Image

Container 17.8 mg (E46eef01 594a 49ca A453 0b680e4ee730 09)

Label for Pitolisant Tablets 17.8 mg film-coated tablets, oral use. The label includes NDC 70748-387-01 and indicates a package size of 30 tablets. Manufactured by Lupin Limited, India, and labeled for Lupin Pharmaceuticals, Inc. in the USA. Storage instructions and dosage note are included, along with a barcode and directions for lot and expiration printing.*

FDA Label Image

Carton 17.8 mg (E46eef01 594a 49ca A453 0b680e4ee730 10)

Box label for Pitolisant Tablets 17.8 mg film-coated tablets. Label includes the NDC number 70748-387-01, manufacturer Lupin Pharmaceuticals, Inc. The package contains 30 tablets, marked Rx only. Storage instructions and manufacturing origin in India are indicated.*

* 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.