orgovyx

Generic: relugolix

Labeler: sumitomo pharma america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name orgovyx
Generic Name relugolix
Labeler sumitomo pharma america, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

relugolix 120 mg/1

Manufacturer
Sumitomo Pharma America, Inc.

Identifiers & Regulatory

Product NDC 72974-120
Product ID 72974-120_0d9200dd-878e-4e93-98af-e1149e84c21f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214621
Listing Expiration 2026-12-31
Marketing Start 2020-12-18

Pharmacologic Class

Established (EPC)
gonadotropin releasing hormone receptor antagonist [epc]
Mechanism of Action
gonadotropin releasing hormone receptor antagonists [moa] cytochrome p450 3a inducers [moa] cytochrome p450 2b6 inducers [moa] breast cancer resistance protein inhibitors [moa] p-glycoprotein inhibitors [moa]
Physiologic Effect
decreased gnrh secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72974120
Hyphenated Format 72974-120

Supplemental Identifiers

RxCUI
2472783 2472789
UNII
P76B05O5V6
NUI
N0000175839 N0000175084 N0000008638 N0000190118 N0000187064 N0000190113 N0000185503

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 orgovyx (source: ndc)
Generic Name relugolix (source: ndc)
Application Number NDA214621 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-01)
  • 16 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-95)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-97)
source: ndc

Packages (3)

72974-120-01 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-01) 72974-120-95 16 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-95) 72974-120-97 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-97)

Ingredients (1)

relugolix (120 mg/1)

Linked Drug Pages (1)

Orgovyx ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0d9200dd-878e-4e93-98af-e1149e84c21f", "openfda": {"nui": ["N0000175839", "N0000175084", "N0000008638", "N0000190118", "N0000187064", "N0000190113", "N0000185503"], "unii": ["P76B05O5V6"], "rxcui": ["2472783", "2472789"], "spl_set_id": ["077a92f6-9f1b-479a-87c7-c92b5db6aa9c"], "pharm_class_pe": ["Decreased GnRH Secretion [PE]"], "pharm_class_epc": ["Gonadotropin Releasing Hormone Receptor Antagonist [EPC]"], "pharm_class_moa": ["Gonadotropin Releasing Hormone Receptor Antagonists [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Sumitomo Pharma America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-01)", "package_ndc": "72974-120-01", "marketing_start_date": "20201218"}, {"sample": true, "description": "16 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-95)", "package_ndc": "72974-120-95", "marketing_start_date": "20230127"}, {"sample": true, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-97)", "package_ndc": "72974-120-97", "marketing_start_date": "20211021"}], "brand_name": "Orgovyx", "product_id": "72974-120_0d9200dd-878e-4e93-98af-e1149e84c21f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 2B6 Inducers [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": "72974-120", "generic_name": "relugolix", "labeler_name": "Sumitomo Pharma America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Orgovyx", "active_ingredients": [{"name": "RELUGOLIX", "strength": "120 mg/1"}], "application_number": "NDA214621", "marketing_category": "NDA", "marketing_start_date": "20201218", "listing_expiration_date": "20261231"}