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United States · US · US:81968-045_75c80bbe-3518-435c-8a6e-121fdc8a9982
AUVELITY
Orange BookUNIISPLATC N06AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAxsome Therapeutics, Inc.
CountryUS (United States)
ATC codeN06AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1181968045141 BOTTLE in 1 CARTON (81968-045-14) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
- ndc11819680453030 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30)
- ndc1181968045311 BOTTLE in 1 CARTON (81968-045-31) / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
- ndc11819680456060 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60)
Annotations
UNII (FDA Substance ID)
ZG7E5POY8O
BUPROPION HYDROCHLORIDE
RxCUI 203204
Orange Book
N215430
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "ZG7E5POY8O",
"rxcui": "203204",
"inchikey": "HEYVINCGKDONRU-UHFFFAOYSA-N",
"display_name": "BUPROPION HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"dcefda7c-9a68-278e-e053-2995a90aec79": {
"match": "brand_token",
"title": "AUVELITY (DEXTROMETHORPHAN HYDROBROMIDE, BUPROPION HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [AXSOME THERAPEUTICS, INC.]",
"spl_version": "14",
"published_date": "2026-05-11"
}
},
"productid": "81968-045_75c80bbe-3518-435c-8a6e-121fdc8a9982",
"productndc": "81968-045",
"dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE",
"orange_book": {
"appl_no": "215430",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "105MG;45MG",
"product_no": "001",
"approval_date": "Aug 18, 2022"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "105MG;30MG",
"product_no": "002",
"approval_date": "Apr 30, 2026"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"proprietary_name": "AUVELITY",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA215430",
"marketing_category": "NDA",
"nonproprietary_name": "dextromethorphan hydrobromide, bupropion hydrochloride",
"start_marketing_date": "20220818",
"active_numerator_strength": "105; 45"
}Related drugs
Other records sharing ATC code N06AX.
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