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United States · US · US:17772-132_453c9f61-1902-44ab-e063-6394a90ab639
QELBREE
Orange BookUNIISPLATC N06AX09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSupernus Pharmaceuticals, Inc
CountryUS (United States)
ATC codeN06AX09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc111777213201100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-132-01)
- ndc1117772132077 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-132-07)
- ndc11177721323030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-132-30)
- ndc11177721326060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-132-60)
- ndc11177721329090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-132-90)
Annotations
UNII (FDA Substance ID)
OQW30I1332
VILOXAZINE HYDROCHLORIDE
RxCUI 142143
Orange Book
N211964
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "OQW30I1332",
"rxcui": "142143",
"inchikey": "HJOCKFVCMLCPTP-UHFFFAOYSA-N",
"display_name": "VILOXAZINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"aedf408d-0f84-418d-9416-7c39ddb0d29a": {
"match": "brand_token",
"title": "QELBREE (VILOXAZINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC]",
"spl_version": "14",
"published_date": "2025-12-10"
}
},
"productid": "17772-132_453c9f61-1902-44ab-e063-6394a90ab639",
"productndc": "17772-132",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "211964",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 100MG BASE",
"product_no": "001",
"approval_date": "Apr 2, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 150MG BASE",
"product_no": "002",
"approval_date": "Apr 2, 2021"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 200MG BASE",
"product_no": "003",
"approval_date": "Apr 2, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VILOXAZINE HYDROCHLORIDE",
"proprietary_name": "QELBREE",
"active_ingred_unit": "mg/1",
"application_number": "NDA211964",
"marketing_category": "NDA",
"nonproprietary_name": "viloxazine hydrochloride",
"start_marketing_date": "20210402",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code N06AX09.
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