Pitolisant Tablet, Film Coated
NDC Package 70748-386-01

11-digit billing NDC: 70748038601
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Pitolisant tablets are indicated for the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy.Pediatric use information is approved for Harmony Biosciences Management Inc.'s WAKIX (pitolisant) tablets. This formulation utilizes a tablet, film coated delivery system. Marketed by Lupin Pharmaceuticals, Inc., this product is identified by NDC 70748-386 and is authorized under FDA application ANDA218846.

Identification & Billing

NDC Package Code
70748-386-01
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code
70748-386
11-Digit Billing Format
70748038601

Clinical Specifications

Proprietary Name
Pitolisant
Non-Proprietary Name
Pitolisant
Substance Name
Pitolisant Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PITOLISANT HYDROCHLORIDE 4.45 mg/1
Pharmacologic Class
Usage Information
Pitolisant Tablets are indicated for the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy.Pediatric use information is approved for Harmony Biosciences Management Inc.'s WAKIX (pitolisant) tablets. However, due to Harmony Biosciences Management Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA218846
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-16-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70748-386-01 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Pitolisant, a human prescription drug labeled by Lupin Pharmaceuticals, Inc.. This tablet, film coated is formulated for oral use and contains pitolisant hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Lupin Pharmaceuticals, Inc. on October 16, 2026. The current certification is valid through December 31, 2027.

How is this Lupin Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70748038601. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
70748-386-01
11-Digit CMS (5-4-2)
70748-0386-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.