United States· US:72974-415_d0b51ef8-0118-4b78-a83f-73338d6dab9b
Myfembree
A medicinal product containing relugolix; estradiol hemihydrate; norethindrone acetate, registered in United States by Sumitomo Pharma America, Inc.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- RELUGOLIX; ESTRADIOL HEMIHYDRATE; NORETHINDRONE ACETATE
- Manufacturer
- Sumitomo Pharma America, Inc
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc1172974-415-99
- ndc11729744150128 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-01)
- ndc1172974415997 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-99)
- ndc1172974-415-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Relugolix; estradiol hemihydrate; norethindrone acetate in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/bcac792e-8216-4640-bfd1-c090c9317ec0 GET /v1/drugs/bcac792e-8216-4640-bfd1-c090c9317ec0?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "40; 1; .5",
"substance": "RELUGOLIX; ESTRADIOL HEMIHYDRATE; NORETHINDRONE ACETATE",
"productndc": "72974-415",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1; mg/1",
"application_number": "NDA214846",
"marketing_category": "NDA"
}See everything about relugolix; estradiol hemihydrate; norethindrone acetate.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.