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United States· US:50742-658_b156b1fa-c3f8-42fd-a8e3-e1f9c58e0175

Estradiol and Norethindrone Acetate

A medicinal product containing estradiol; norethindrone acetate, registered in United States by Ingenus Pharmaceuticals, LLC.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedEstradiol and Norethindrone AcetateATC—REGISTER NO.US:50742-658_b156b1fa…PACKS LISTED6CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ESTRADIOL; NORETHINDRONE ACETATE
Manufacturer
Ingenus Pharmaceuticals, LLC
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 · 6

  • ndc11
    50742-658-28
  • ndc11
    5074265828
    1 BLISTER PACK in 1 CARTON (50742-658-28) / 28 TABLET in 1 BLISTER PACK
  • ndc11
    5074265868
    6 BLISTER PACK in 1 CARTON (50742-658-68) / 28 TABLET in 1 BLISTER PACK
  • ndc11
    5074265884
    3 BLISTER PACK in 1 CARTON (50742-658-84) / 28 TABLET in 1 BLISTER PACK
  • ndc11
    50742-658-84
  • ndc11
    50742-658-68

Regulatory notes

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

Same medicine, other countries

Estradiol; norethindrone acetate in 13 other countries

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

All estradiol; norethindrone acetate products

Authorised across Europe · EMA

The same active substance is authorised in 27 EEA countries. Names it is sold under:

  • Austria · Activelle, Kliogest
  • Belgium · Activelle, Activelle Minor
  • Bulgaria · Активел, Трисеквенс
  • Cyprus · Trisequens
  • Czechia · Activelle, Kliogest
  • Germany · Activelle, Cliovelle
  • Denmark · Activelle, Activelle Low
  • Estonia · Activelle, Eviana
  • Spain · Activelle, Duofemme
  • Finland · Activelle, Cliovelle
  • France · Activelle, Kliogest
  • Greece · Trisequens
  • Croatia · Activelle, Novofem
  • Hungary · Activelle, Kliogest
  • Ireland · Activelle, Kliogest
  • Iceland · Activelle, Activelle Low
  • Italy · Activelle
  • Lithuania · Activelle, Kliogest
  • Luxembourg · Activelle, Activelle Minor
  • Latvia · Activelle, Kliogest
  • Netherlands · Activelle
  • Norway · Activelle, Cliovelle
  • Poland · Cliovelle, Kliogest
  • Portugal · Activelle, Kliogest
  • Sweden · Activelle, Cliovelle
  • Slovenia · Activelle, Kliogest
  • Slovakia · Activelle, Novofem

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/800a03a1-c57b-4dde-be0a-33e07644cade
GET /v1/drugs/800a03a1-c57b-4dde-be0a-33e07644cade?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": ".5; .1",
  "substance": "ESTRADIOL; NORETHINDRONE ACETATE",
  "productndc": "50742-658",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA210612",
  "marketing_category": "ANDA"
}

See everything about estradiol; 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.