Orgovyx
These highlights do not include all the information needed to use ORGOVYX safely and effectively. See full prescribing information for ORGOVYX. ORGOVYX (relugolix) tablets, for oral use Initial U.S. Approval: 2020
Approved
Approval ID
077a92f6-9f1b-479a-87c7-c92b5db6aa9c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2024
Manufacturers
FDA
Sumitomo Pharma America, Inc
DUNS: 131661746
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
relugolix
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72974-120
Application NumberNDA214621
Product Classification
M
Marketing Category
C73594
G
Generic Name
relugolix
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (9)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
RELUGOLIXActive
Quantity: 120 mg in 1 1
Code: P76B05O5V6
Classification: ACTIB