United States· US:50261-211_fca91f4b-94dd-41c9-90c3-c50c4b2dcd76
Bijuva
A medicinal product containing estradiol; progesterone, registered in United States by Mayne Pharma LLC.
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
- ESTRADIOL; PROGESTERONE
- Manufacturer
- Mayne Pharma LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- July 26, 2026
Packs & prices · 2
- ndc1150261-211-05
- ndc1150261211051 BLISTER PACK in 1 CARTON (50261-211-05) / 5 CAPSULE in 1 BLISTER PACK
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Estradiol; progesterone in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaBIJUVAKNIGHT THERAPEUTICS INC.
- SwitzerlandBijuva
- SpainBIJUVA 1 MG/100 MG CAPSULAS BLANDASTheramex Ireland Limited
- NetherlandsBijuva 1 mg/100 mg zachte capsulesTheramex Ireland Limited
- PolandBijuvaTheramex Ireland Limited
- United KingdomBijuve 1mg/100mg capsulesTheramex HQ UK Ltd
Authorised across Europe · EMA
The same active substance is authorised in 1 EEA country. Names it is sold under:
- Belgium · Duogestan
Source: European Medicines Agency, Article 57 product data.
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/cb9e4e18-36b2-4c47-98d4-3e7807bff8fa GET /v1/drugs/cb9e4e18-36b2-4c47-98d4-3e7807bff8fa?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": "1; 100",
"substance": "ESTRADIOL; PROGESTERONE",
"productndc": "50261-211",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "NDA210132",
"marketing_category": "NDA"
}See everything about estradiol; progesterone.
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.