🇺🇸
United States · US · US:72028-045_377224a0-fa6e-498f-b42e-9f8d191728e2
Wakix
Orange BookUNIISPLATC N07XX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHarmony Biosciences, LLC
CountryUS (United States)
ATC codeN07XX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172028045031 BOTTLE, PLASTIC in 1 CARTON (72028-045-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
YV33CH63HI
PITOLISANT HYDROCHLORIDE
RxCUI 2197879
Orange Book
N211150
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "YV33CH63HI",
"rxcui": "2197879",
"inchikey": "XLFKECRRMPOAQS-UHFFFAOYSA-N",
"display_name": "PITOLISANT HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"8daa5562-824e-476c-9652-26ceef3d4b0e": {
"match": "brand_token",
"title": "WAKIX (PITOLISANT HYDROCHLORIDE) TABLET, FILM COATED [HARMONY BIOSCIENCES, LLC]",
"spl_version": "18",
"published_date": "2026-02-26"
}
},
"productid": "72028-045_377224a0-fa6e-498f-b42e-9f8d191728e2",
"productndc": "72028-045",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211150",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 4.45MG BASE",
"product_no": "001",
"approval_date": "Aug 14, 2019"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 17.8MG BASE",
"product_no": "002",
"approval_date": "Aug 14, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PITOLISANT HYDROCHLORIDE",
"proprietary_name": "Wakix",
"active_ingred_unit": "mg/1",
"application_number": "NDA211150",
"marketing_category": "NDA",
"nonproprietary_name": "PITOLISANT HYDROCHLORIDE",
"start_marketing_date": "20190814",
"active_numerator_strength": "4.45"
}Related drugs
Other records sharing ATC code N07XX11.
Access this data programmatically
Query Wakix and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.