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United States · US · US:81968-345_75c80bbe-3518-435c-8a6e-121fdc8a9982
AUVELITY
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAxsome Therapeutics, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1181968345011 KIT in 1 KIT (81968-345-01) * 1 BOTTLE in 1 CARTON / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
- ndc1181968345031 KIT in 1 KIT (81968-345-03) * 1 BOTTLE in 1 CARTON / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
Annotations
Orange Book
N215430
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"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": "81968-345_75c80bbe-3518-435c-8a6e-121fdc8a9982",
"productndc": "81968-345",
"dosage_form": "KIT",
"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": null,
"proprietary_name": "AUVELITY",
"active_ingred_unit": null,
"application_number": "NDA215430",
"marketing_category": "NDA",
"nonproprietary_name": "dextromethorphan hydrobromide, bupropion hydrochloride",
"start_marketing_date": "20260601",
"active_numerator_strength": null
}Access this data programmatically
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