🇺🇸
United States · US · US:81968-350_f0a0a507-33cd-4ab1-b438-12996fae6ae1
SUNOSI
Orange BookUNIISPLATC N06BA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAxsome Therapeutics, Inc.
CountryUS (United States)
ATC codeN06BA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11819683500130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (81968-350-01)
- ndc1181968350077 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07)
- ndc11819683501010 BLISTER PACK in 1 CARTON (81968-350-10) / 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07)
Annotations
UNII (FDA Substance ID)
939U7C91AI
SOLRIAMFETOL
RxCUI 2121751
Orange Book
N211230
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "939U7C91AI",
"rxcui": "2121751",
"inchikey": "UCTRAOBQFUDCSR-SECBINFHSA-N",
"display_name": "SOLRIAMFETOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"362f206b-73e7-4009-8c34-5a9df55679ab": {
"match": "brand_token",
"title": "SUNOSI (SOLRIAMFETOL) TABLET, FILM COATED [AXSOME THERAPEUTICS, INC.]",
"spl_version": "6",
"published_date": "2026-05-11"
}
},
"productid": "81968-350_f0a0a507-33cd-4ab1-b438-12996fae6ae1",
"productndc": "81968-350",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "211230",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 75MG BASE",
"product_no": "001",
"approval_date": "Jun 17, 2019"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 150MG BASE",
"product_no": "002",
"approval_date": "Jun 17, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SOLRIAMFETOL",
"proprietary_name": "SUNOSI",
"active_ingred_unit": "mg/1",
"application_number": "NDA211230",
"marketing_category": "NDA",
"nonproprietary_name": "solriamfetol",
"start_marketing_date": "20190618",
"active_numerator_strength": "75"
}Related drugs
Other records sharing ATC code N06BA14.
- PLSunosiAtnahs Pharma Netherlands B.V.
- ISSunosiAtnahs Pharma Netherlands B.V.
- ISSunosiAtnahs Pharma Netherlands B.V.
- PLSunosiAtnahs Pharma Netherlands B.V.
- NOSunosiAtnahs Pharma Netherlands B.V.
- DKSunosiAtnahs Pharma Netherlands B.V.
- DKSunosiAtnahs Pharma Netherlands B.V.
- NOSunosiAtnahs Pharma Netherlands B.V.
Access this data programmatically
Query SUNOSI 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.