Orilissa
These highlights do not include all the information needed to use ORILISSA safely and effectively. See full prescribing information for ORILISSA. ORILISSA (elagolix) tablets, for oral use Initial U.S. Approval: 2018
Approved
Approval ID
a86757b3-09c5-fd3b-1223-244e94f50a66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 5, 2023
Manufacturers
FDA
AbbVie Inc.
DUNS: 078458370
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Elagolix
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0074-0038
Application NumberNDA210450
Product Classification
M
Marketing Category
C73594
G
Generic Name
Elagolix
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2023
FDA Product Classification
INGREDIENTS (11)
ELAGOLIX SODIUMActive
Quantity: 150 mg in 1 1
Code: 5948VUI423
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM CARBONATE MONOHYDRATEInactive
Code: 2A1Q1Q3557
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CARMINIC ACIDInactive
Code: CID8Z8N95N
Classification: IACT
Elagolix
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0074-0039
Application NumberNDA210450
Product Classification
M
Marketing Category
C73594
G
Generic Name
Elagolix
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2023
FDA Product Classification
INGREDIENTS (11)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM CARBONATE MONOHYDRATEInactive
Code: 2A1Q1Q3557
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ELAGOLIX SODIUMActive
Quantity: 200 mg in 1 1
Code: 5948VUI423
Classification: ACTIM
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT