orilissa

Generic: elagolix

Labeler: abbvie inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name orilissa
Generic Name elagolix
Labeler abbvie inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

elagolix sodium 200 mg/1

Manufacturer
AbbVie Inc.

Identifiers & Regulatory

Product NDC 0074-0039
Product ID 0074-0039_12b19eff-edfe-4218-96b3-f2446c6f2a6a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210450
Listing Expiration 2026-12-31
Marketing Start 2018-07-23

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00740039
Hyphenated Format 0074-0039

Supplemental Identifiers

RxCUI
2049852 2049858 2049860 2049862
UNII
5948VUI423

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name orilissa (source: ndc)
Generic Name elagolix (source: ndc)
Application Number NDA210450 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (0074-0039-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (0074-0039-56) / 14 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

0074-0039-14 1 BLISTER PACK in 1 CARTON (0074-0039-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK 0074-0039-56 4 BLISTER PACK in 1 CARTON (0074-0039-56) / 14 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

elagolix sodium (200 mg/1)

Linked Drug Pages (1)

Orilissa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "12b19eff-edfe-4218-96b3-f2446c6f2a6a", "openfda": {"unii": ["5948VUI423"], "rxcui": ["2049852", "2049858", "2049860", "2049862"], "spl_set_id": ["a86757b3-09c5-fd3b-1223-244e94f50a66"], "manufacturer_name": ["AbbVie Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BLISTER PACK in 1 CARTON (0074-0039-14)  / 14 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0074-0039-14", "marketing_start_date": "20180723"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (0074-0039-56)  / 14 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0074-0039-56", "marketing_start_date": "20180723"}], "brand_name": "Orilissa", "product_id": "0074-0039_12b19eff-edfe-4218-96b3-f2446c6f2a6a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "0074-0039", "generic_name": "Elagolix", "labeler_name": "AbbVie Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Orilissa", "active_ingredients": [{"name": "ELAGOLIX SODIUM", "strength": "200 mg/1"}], "application_number": "NDA210450", "marketing_category": "NDA", "marketing_start_date": "20180723", "listing_expiration_date": "20261231"}