Prescription drug · NDA
Wakix (Pitolisant hydrochloride) NDC 72028-045
Pitolisant hydrochloride 4.45 mg/1 · Tablet, Film coated · Oral · Harmony Biosciences, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72028-045-03 | 72028004503 | 1 BOTTLE, PLASTIC in 1 CARTON (72028-045-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Aug 14, 2019 |
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)
- Wakix
- Generic name (nonproprietary)
- pitolisant hydrochloride
- Active ingredients
- Pitolisant hydrochloride — 4.45 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Harmony Biosciences, LLCNDC labeler code 72028
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211150
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inducers (Mechanism)Histamine H3 Receptor Antagonists (Mechanism)Histamine H3 Receptor Inverse Agonists (Mechanism)
- Identifiers
- Product ID 72028-045_377224a0-fa6e-498f-b42e-9f8d191728e2SPL ID 377224a0-fa6e-498f-b42e-9f8d191728e2SPL set ID 8daa5562-824e-476c-9652-26ceef3d4b0eRxCUI 2197884, 2197890, 2197892, 2197894UNII YV33CH63HI
- 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
N472028004503followed by a unit qualifier and the quantityPackage 72028-0045-03. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 72028-045
- What is NDC 72028-045?
- 72028-045 is the product NDC for Wakix (pitolisant hydrochloride), Pitolisant hydrochloride 4.45 mg/1 tablet, film coated, listed with the FDA by Harmony Biosciences, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Wakix (Pitolisant hydrochloride).
- What is the active ingredient?
- Pitolisant hydrochloride.
- Who is the labeler?
- Harmony Biosciences, LLC, NDC labeler code 72028. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Wakix?
- 1 other product NDC are listed under this name. See all Wakix NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Wakix products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Wakixpitolisant hydrochloride | Pitolisant hydrochloride 17.8 mg/1 | Tablet, Film coatedOral | Harmony Biosciences, LLC | 72028-178 | 72028-0178-03 |
Other NDCs under NDA 211150
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Wakixpitolisant hydrochloride | Pitolisant hydrochloride 17.8 mg/1 | Tablet, Film coatedOral | Harmony Biosciences, LLC | 72028-178 |