🇺🇸
United States · US · US:0074-0038_12b19eff-edfe-4218-96b3-f2446c6f2a6a
Orilissa
Orange BookUNIISPLATC H01CC03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAbbVie Inc.
CountryUS (United States)
ATC codeH01CC03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1100740038071 BLISTER PACK in 1 CARTON (0074-0038-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1100740038284 BLISTER PACK in 1 CARTON (0074-0038-28) / 7 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
5948VUI423
ELAGOLIX SODIUM
RxCUI 2049847
Orange Book
N210450
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5948VUI423",
"rxcui": "2049847",
"inchikey": "DQYGXRQUFSRDCH-UQIIZPHYSA-M",
"display_name": "ELAGOLIX SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a86757b3-09c5-fd3b-1223-244e94f50a66": {
"match": "brand_token",
"title": "ORILISSA (ELAGOLIX) TABLET, FILM COATED [ABBVIE INC.]",
"spl_version": "111",
"published_date": "2025-12-25"
}
},
"productid": "0074-0038_12b19eff-edfe-4218-96b3-f2446c6f2a6a",
"productndc": "0074-0038",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210450",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 150MG BASE",
"product_no": "001",
"approval_date": "Jul 23, 2018"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 200MG BASE",
"product_no": "002",
"approval_date": "Jul 23, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ELAGOLIX SODIUM",
"proprietary_name": "Orilissa",
"active_ingred_unit": "mg/1",
"application_number": "NDA210450",
"marketing_category": "NDA",
"nonproprietary_name": "Elagolix",
"start_marketing_date": "20180723",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code H01CC03.
Access this data programmatically
Query Orilissa 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.