What is NDC 70748-386?

70748-386 is the product NDC for Pitolisant, Pitolisant hydrochloride 4.45 mg/1 tablet, film coated, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Lupin Pharmaceuticals, Inc., NDC labeler code 70748. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Pitolisant?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pitolisant NDC 70748-386 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70748-386Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70748-0386Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
70748-386-01	7074803860170748038601	1 BOTTLE in 1 CARTON (70748-386-01) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 16, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Pitolisant
Generic name (nonproprietary): pitolisant
Active ingredients: Pitolisant hydrochloride — 4.45 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.NDC labeler code 70748
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218846
Marketing start: Oct 16, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 3A4 Inducers (Mechanism)Histamine H3 Receptor Antagonists (Mechanism)Histamine H3 Receptor Inverse Agonists (Mechanism)
Identifiers: Product ID 70748-386_e46eef01-594a-49ca-a453-0b680e4ee730SPL ID e46eef01-594a-49ca-a453-0b680e4ee730SPL set ID 6fb94d86-5154-4b69-8470-d1145d426312RxCUI 2197884, 2197892UNII YV33CH63HIUPC 0370748386019, 0370748387016
Pharmacologic class: Histamine-3 Receptor Antagonist/Inverse Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470748038601 followed by a unit qualifier and the quantity

Package 70748-0386-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Oct 16, 2026.

Indications (excerpt from the label)

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. Pitolisant tablets are histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70748-386

What is NDC 70748-386?: 70748-386 is the product NDC for Pitolisant, Pitolisant hydrochloride 4.45 mg/1 tablet, film coated, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pitolisant.
What is the active ingredient?: Pitolisant hydrochloride.
Who is the labeler?: Lupin Pharmaceuticals, Inc., NDC labeler code 70748. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pitolisant?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 218846

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 218846
Product	Strength	Form · route	Labeler	Product NDC
Pitolisant	Pitolisant hydrochloride 17.8 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	70748-387