United States· US:59651-439_2df3b31e-32a6-49cd-a636-5b7779a5ed0c

ESTRADIOL VAGINAL INSERTS

A medicinal product containing estradiol hemihydrate, registered in United States by Aurobindo Pharma Limited.

US label

Checked against FDA National Drug Code directory (United States) on September 27, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about estradiol hemihydrateAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)

Active substance: ESTRADIOL HEMIHYDRATE
Manufacturer: Aurobindo Pharma Limited
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

ndc11
5965143908
8 APPLICATOR in 1 CARTON (59651-439-08) / 1 TABLET, FILM COATED in 1 APPLICATOR
ndc11
5965143918
18 APPLICATOR in 1 CARTON (59651-439-18) / 1 TABLET, FILM COATED in 1 APPLICATOR
ndc11
59651-439-08
ndc11
59651-439-18

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Estradiol hemihydrate in 9 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All estradiol hemihydrate products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

Austria · Estrogel, Linoladiol
Belgium · Dermestril, Dermestril 100
Bulgaria · Лензето, Линоладиол N
Czechia · Estrahexal, Lenzetto
Germany · Dermestril 25, Dermestril 50
Denmark · Lenzetto, Østradiol Dlf
Estonia · Lenzetto, Linoladiol N
Spain · Estraderm Matrix, Estring
Finland · Divigel, Estrena
France · Estreva, Estring
United Kingdom (Northern Ireland) · Elleste, Estraderm Mx
Greece · Lenzetto, Vagirux
Croatia · Lenzetto, Linoladiol
Hungary · Divigel, Lenzetto
Ireland · Evorel, Fematab
Iceland · Estradiol Hexal, Femanest
Italy · Dermestril-Septem, Estraderm Mx
Liechtenstein · Rewellfem
Lithuania · Lenzetto, Linoladiol N
Luxembourg · Dermestril 25, Dermestril-Septem
Latvia · Lenzetto, Linoladiol N
Malta · Estradiol Sandoz, Fematab
Netherlands · Estradiol Sandoz, Lenzetto
Norway · Estradiol Hexal, Lenzetto
Poland · Estreva, Fem 7
Portugal · Dermestril-Septem, Estreva
Romania · Lenzetto
Sweden · Femanest, Lenzetto
Slovenia · Estrofem, Lenzetto
Slovakia · Lenzetto, Vagirux

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/400c4a6f-3bd9-419f-898c-45d45eab6cae
GET /v1/drugs/400c4a6f-3bd9-419f-898c-45d45eab6cae?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": "VAGINAL",
  "source": "ndc",
  "strength": "10",
  "substance": "ESTRADIOL HEMIHYDRATE",
  "productndc": "59651-439",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "ug/1",
  "application_number": "ANDA216550",
  "marketing_category": "ANDA"
}

API reference MCP server Plans

See everything about estradiol hemihydrate.

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.

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