NDC 72028-045

Wakix

Pitolisant Hydrochloride

Wakix is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Harmony Biosciences, Llc. The primary component is Pitolisant Hydrochloride.

• Product ID: 72028-045_073b869a-4ba9-4f77-af29-bc902974ada6
• NDC: 72028-045
• Product Type: Human Prescription Drug
• Proprietary Name: Wakix
• Generic Name: Pitolisant Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-08-14
• Marketing Category: NDA / NDA
• Application Number: NDA211150
• Labeler Name: Harmony Biosciences, LLC
• Substance Name: PITOLISANT HYDROCHLORIDE
• Active Ingredient Strength: 4 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 72028-045-03

1 BOTTLE, PLASTIC in 1 CARTON (72028-045-03) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2019-08-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72028-045-03 [72028004503]

Wakix TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA211150
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-14

Drug Details

Active Ingredients

Ingredient	Strength
PITOLISANT HYDROCHLORIDE	4.45 mg/1

OpenFDA Data

• SPL SET ID: 8daa5562-824e-476c-9652-26ceef3d4b0e
• Manufacturer:
  • Harmony Biosciences, LLC
• UNII:
  • YV33CH63HI
• RxNorm Concept Unique ID - RxCUI:
  • 2197890
  • 2197884
  • 2197892
  • 2197894

NDC Crossover Matching brand name "Wakix" or generic name "Pitolisant Hydrochloride"

NDC	Brand Name	Generic Name
72028-045	Wakix	PITOLISANT HYDROCHLORIDE
72028-178	Wakix	PITOLISANT HYDROCHLORIDE