FDA.reportPublic FDA data

Orilissa

Product NDC
0074-0038
11-digit product format
000740038
Labeler code
0074
Product ID
0074-0038_12b19eff-edfe-4218-96b3-f2446c6f2a6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Elagolix
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AbbVie Inc.
Application
NDA210450
Marketing category
NDA
Marketing start
2018-07-23
Substance
ELAGOLIX SODIUM
Active strength
150 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Orilissa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELAGOLIX SODIUM150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5948VUI423
Rxcui2049852, 2049858, 2049860, 2049862

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
84ef4224-f07c-4c4b-8889-3ae70f4b627dProduct name120181003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-0038-01Orilissa7 in 1 BLISTER PACKTABLET, FILM COATED7111
0074-0038-01Orilissa1 in 1 CARTONTABLET, FILM COATED1111
0074-0038-07Orilissa1 in 1 CARTONTABLET, FILM COATED1111
0074-0038-07Orilissa7 in 1 BLISTER PACKTABLET, FILM COATED7111
0074-0038-28Orilissa7 in 1 BLISTER PACKTABLET, FILM COATED7111
0074-0038-28Orilissa4 in 1 CARTONTABLET, FILM COATED4111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-0038-28EA - Each0074-0038dfab128c-9de3-4ef5-bca5-c4d04bc7262712018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-0038ORILISSA (ELAGOLIX) TABLET, FILM COATED [ABBVIE INC.]108Current NDC, Legacy NDC, 6 package rows20241013_a86757b3-09c5-fd3b-1223-244e94f50a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2049852elagolix 150 MG Oral TabletPSNa86757b3-09c5-fd3b-1223-244e94f50a66111
2049860elagolix 200 MG Oral TabletPSNa86757b3-09c5-fd3b-1223-244e94f50a66111
2049858Orilissa 150 MG Oral TabletPSNa86757b3-09c5-fd3b-1223-244e94f50a66111
2049862Orilissa 200 MG Oral TabletPSNa86757b3-09c5-fd3b-1223-244e94f50a66111
2049858elagolix 150 MG Oral Tablet [Orilissa]SBDa86757b3-09c5-fd3b-1223-244e94f50a66111
2049862elagolix 200 MG Oral Tablet [Orilissa]SBDa86757b3-09c5-fd3b-1223-244e94f50a66111
2049852elagolix 150 MG Oral TabletSCDa86757b3-09c5-fd3b-1223-244e94f50a66111
2049860elagolix 200 MG Oral TabletSCDa86757b3-09c5-fd3b-1223-244e94f50a66111
2049852elagolix 150 MG (as elagolix sodium 155.2 MG) Oral TabletSYa86757b3-09c5-fd3b-1223-244e94f50a66111
2049860elagolix 200 MG (as egalolix sodium 207 MG) Oral TabletSYa86757b3-09c5-fd3b-1223-244e94f50a66111
2049858Orilissa 150 MG Oral TabletSYa86757b3-09c5-fd3b-1223-244e94f50a66111
2049862Orilissa 200 MG Oral TabletSYa86757b3-09c5-fd3b-1223-244e94f50a66111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-0038-01000740038011 BLISTER PACK in 1 CARTON (0074-0038-01) > 7 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2018-07-230000-00-00NoNoCurrent
0074-0038-07000740038071 BLISTER PACK in 1 CARTON (0074-0038-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2018-07-230000-00-00YesNoCurrent
0074-0038-28000740038284 BLISTER PACK in 1 CARTON (0074-0038-28) / 7 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2018-07-230000-00-00NoNoCurrent