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United States · US · US:72974-415_d0b51ef8-0118-4b78-a83f-73338d6dab9b
Myfembree
Orange BookUNIISPLATC G03CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSumitomo Pharma America, Inc
CountryUS (United States)
ATC codeG03CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11729744150128 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-01)
- ndc1172974415997 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-99)
Annotations
UNII (FDA Substance ID)
CXY7B3Q98Z
ESTRADIOL HEMIHYDRATE
RxCUI 236859
Orange Book
N214846
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "CXY7B3Q98Z",
"rxcui": "236859",
"inchikey": "ZVVGLAMWAQMPDR-WVEWYJOQSA-N",
"display_name": "ESTRADIOL HEMIHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"fc3feb73-cc84-43a8-aa32-b262460495e8": {
"match": "brand_token",
"title": "MYFEMBREE (RELUGOLIX, ESTRADIOL HEMIHYDRATE, AND NORETHINDRONE ACETATE) TABLET, FILM COATED [SUMITOMO PHARMA AMERICA, INC]",
"spl_version": "18",
"published_date": "2025-09-15"
}
},
"productid": "72974-415_d0b51ef8-0118-4b78-a83f-73338d6dab9b",
"productndc": "72974-415",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "214846",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1MG;0.5MG;40MG",
"product_no": "001",
"approval_date": "May 26, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL HEMIHYDRATE; NORETHINDRONE ACETATE; RELUGOLIX",
"proprietary_name": "Myfembree",
"active_ingred_unit": "mg/1; mg/1; mg/1",
"application_number": "NDA214846",
"marketing_category": "NDA",
"nonproprietary_name": "relugolix, estradiol hemihydrate, and norethindrone acetate",
"start_marketing_date": "20210526",
"active_numerator_strength": "1; .5; 40"
}Related drugs
Other records sharing ATC code G03CA.
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