United States· US:0378-4643_e1deb37a-8362-4275-a04c-7abcbb2e9f56
Estradiol
A medicinal product containing estradiol, registered in United States by Mylan Pharmaceuticals 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
- ESTRADIOL
- Manufacturer
- Mylan Pharmaceuticals 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 · 2
- ndc1103784643268 POUCH in 1 CARTON (0378-4643-26) / 1 PATCH in 1 POUCH (0378-4643-16) / 3.5 d in 1 PATCH
- ndc110378-4643-26
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Estradiol in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomAdgyn Estro 2mg tabletsKyowa Kirin Ltd
- SwedenDivigel 0,5 mg GelOrion Corporation
- NorwayDelestrogenPar Pharmaceutical
- SwitzerlandDivigel
- NetherlandsCetura 0,5 mg tablettenACE Pharmaceuticals B.V.
- PolandDivigel 0,1%Orion Corporation
- SpainDIVIGEL 0,5 MG GEL TRANSDERMICO EN SOBRES EFGOrion Corporation
- CanadaCLIMARA 25BAYER INC
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Estrofem, Femseven
- Belgium · Estradiol Besins, Estrofem
- Bulgaria · Естрогел, Естрофем
- Cyprus · Vagifem
- Czechia · Estradiol Besins, Estrofem
- Germany · Estradiol Fem Jenapharm, Estrifam
- Denmark · Divigel, Ercostrol
- Estonia · Divigel, Estradiol Besins
- Spain · Divigel, Estradiol Besins
- Finland · Divigel, Estradot
- France · Dermestril, Dermestril Septem
- United Kingdom (Northern Ireland) · Elleste, Elleste Solo Mx
- Greece · Vagifem
- Croatia · Estradiol Besins, Estrofem
- Hungary · Estradiol Besins, Estrofem
- Ireland · Divigel, Estradiol Sun
- Iceland · Estring, Estrofem
- Italy · Dermestril, Femseven
- Lithuania · Divigel, Estradiol Besins
- Luxembourg · Dermestril 100, Dermestril 25
- Latvia · Estradiol Besins, Estrofem
- Malta · Oestrogel Pump-Pack, Vagifem
- Netherlands · Cetura, Estradiol Sandoz
- Norway · Estradot, Estrogel
- Poland · Divigel, Estrofem
- Portugal · Dermestril, Estradot
- Romania · Estradiol Besins
- Sweden · Divigel, Estradiol Besins
- Slovenia · Estradiol Besins, Vagifem
- Slovakia · Estradiol Besins, Estrofem
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/c83f7616-5578-47cb-80b7-c1de900e07a3 GET /v1/drugs/c83f7616-5578-47cb-80b7-c1de900e07a3?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": "TRANSDERMAL",
"source": "ndc",
"strength": ".0375",
"substance": "ESTRADIOL",
"productndc": "0378-4643",
"dosage_form": "PATCH",
"dea_schedule": null,
"strength_unit": "mg/d",
"application_number": "ANDA201675",
"marketing_category": "ANDA"
}See everything about estradiol.
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.