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United States · US · US:72974-120_0d9200dd-878e-4e93-98af-e1149e84c21f
Orgovyx
Orange BookUNIISPLATC L02BX04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSumitomo Pharma America, Inc.
CountryUS (United States)
ATC codeL02BX04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11729741200130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-01)
- ndc11729741209516 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-95)
- ndc11729741209730 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-97)
Annotations
UNII (FDA Substance ID)
P76B05O5V6
RELUGOLIX
RxCUI 2472778
Orange Book
N214621
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "P76B05O5V6",
"rxcui": "2472778",
"inchikey": "AOMXMOCNKJTRQP-UHFFFAOYSA-N",
"display_name": "RELUGOLIX",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"077a92f6-9f1b-479a-87c7-c92b5db6aa9c": {
"match": "brand_token",
"title": "ORGOVYX (RELUGOLIX) TABLET, FILM COATED [SUMITOMO PHARMA AMERICA, INC.]",
"spl_version": "12",
"published_date": "2025-11-17"
}
},
"productid": "72974-120_0d9200dd-878e-4e93-98af-e1149e84c21f",
"productndc": "72974-120",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "214621",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "120MG",
"product_no": "001",
"approval_date": "Dec 18, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RELUGOLIX",
"proprietary_name": "Orgovyx",
"active_ingred_unit": "mg/1",
"application_number": "NDA214621",
"marketing_category": "NDA",
"nonproprietary_name": "relugolix",
"start_marketing_date": "20201218",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code L02BX04.
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