FDA.reportPublic FDA data

Wakix

Product NDC
72028-178
11-digit product format
720280178
Labeler code
72028
Product ID
72028-178_377224a0-fa6e-498f-b42e-9f8d191728e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PITOLISANT HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Harmony Biosciences, LLC
Application
NDA211150
Marketing category
NDA
Marketing start
2019-08-14
Substance
PITOLISANT HYDROCHLORIDE
Active strength
17.8 mg/1
Pharmacologic classes
Cytochrome P450 3A4 Inducers [MoA], Histamine H3 Receptor Antagonists [MoA], Histamine H3 Receptor Inverse Agonists [MoA], Histamine-3 Receptor Antagonist/Inverse Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Wakix
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PITOLISANT HYDROCHLORIDE17.8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYV33CH63HI
Rxcui2197884, 2197890, 2197892, 2197894

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4a6f27b-728d-462c-ae88-b57b9da8371dProduct name120200129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72028-178-03Wakix1 in 1 CARTONTABLET, FILM COATED118
72028-178-03Wakix30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72028-178-03EA - Each72028-178e7852c0f-9ea2-44ff-9a20-81a77d3798f912019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72028-178WAKIX (PITOLISANT HYDROCHLORIDE) TABLET, FILM COATED [HARMONY BIOSCIENCES, LLC]13Current NDC, Legacy NDC, 2 package rows20250515_8daa5562-824e-476c-9652-26ceef3d4b0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2197892pitolisant 17.8 MG Oral TabletPSN8daa5562-824e-476c-9652-26ceef3d4b0e18
2197884pitolisant 4.45 MG Oral TabletPSN8daa5562-824e-476c-9652-26ceef3d4b0e18
2197894Wakix 17.8 MG Oral TabletPSN8daa5562-824e-476c-9652-26ceef3d4b0e18
2197890Wakix 4.45 MG Oral TabletPSN8daa5562-824e-476c-9652-26ceef3d4b0e18
2197894pitolisant 17.8 MG Oral Tablet [Wakix]SBD8daa5562-824e-476c-9652-26ceef3d4b0e18
2197890pitolisant 4.45 MG Oral Tablet [Wakix]SBD8daa5562-824e-476c-9652-26ceef3d4b0e18
2197892pitolisant 17.8 MG Oral TabletSCD8daa5562-824e-476c-9652-26ceef3d4b0e18
2197884pitolisant 4.45 MG Oral TabletSCD8daa5562-824e-476c-9652-26ceef3d4b0e18
2197892pitolisant 17.8 MG (as pitolisant HCl 20 MG) Oral TabletSY8daa5562-824e-476c-9652-26ceef3d4b0e18
2197884pitolisant 4.45 MG (as pitolisant HCl 5 MG) Oral TabletSY8daa5562-824e-476c-9652-26ceef3d4b0e18
2197894Wakix 17.8 MG (as pitolisant HCl 20 MG) Oral TabletSY8daa5562-824e-476c-9652-26ceef3d4b0e18
2197894Wakix 17.8 MG Oral TabletSY8daa5562-824e-476c-9652-26ceef3d4b0e18
2197890Wakix 4.45 MG (as pitolisant HCl 5 MG) Oral TabletSY8daa5562-824e-476c-9652-26ceef3d4b0e18
2197890Wakix 4.45 MG Oral TabletSY8daa5562-824e-476c-9652-26ceef3d4b0e18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72028-178-03720280178031 BOTTLE, PLASTIC in 1 CARTON (72028-178-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2019-08-140000-00-00NoNoCurrent