United States· US:55494-580_2e1f0dd2-9e5b-413e-e063-6294a90a636a

Osphena

A ospemifene product containing ospemifene, registered in United States by Duchesnay USA, Inc.. The same ATC class is registered in 11 of our 19 countries.

ATC G03XC05US 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…normalisedOsphenaATCG03XC05REGISTER NO.US:55494-580_2e1f0dd2…PACKS LISTED8CHECKEDSeptember 27, 2026

Where it is registered

Ospemifene is registered in 11 of 19 countries.

Countries holding a registration under ATC G03XC05 (ospemifene), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 6 of them publish a price we can compare per daily dose

Ospemifene · ATC G03XC05

11 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Polandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
OSPEMIFENE
Manufacturer
Duchesnay USA, Inc.
Country
United States (US)
ATC code
G03XC05
ATC class
Ospemifene
Defined daily dose
60 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 8

  • ndc11
    5549458018
    1 BLISTER PACK in 1 PACKAGE (55494-580-18) / 15 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    5549458030
    30 TABLET, FILM COATED in 1 BOTTLE (55494-580-30)
  • ndc11
    5549458055
    1 BLISTER PACK in 1 PACKAGE (55494-580-55) / 5 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    5549458090
    90 TABLET, FILM COATED in 1 BOTTLE (55494-580-90)
  • ndc11
    55494-580-18
  • ndc11
    55494-580-30
  • ndc11
    55494-580-55
  • ndc11
    55494-580-90

Regulatory notes

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

Interactions

52 interactions on record for ospemifene.

Graded by severity as the source publishes them — 7 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Ospemifene · interactions on record

52 records

  • 7 severe
  • 45 moderate

Most severe, free to view

  • Tranexamic acidB02AA02severe
  • FluconazoleJ02AC01severe
  • CarfilzomibL01XG02severe
  • CarfilzomibL01XX45severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Ospemifene in 11 other countries

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

All ospemifene products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Senshio
  • Liechtenstein · Senshio
  • Norway · Senshio

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/b1c4368d-d675-4156-9753-227d78e930f5
GET /v1/drugs/b1c4368d-d675-4156-9753-227d78e930f5?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": "60",
  "substance": "OSPEMIFENE",
  "productndc": "55494-580",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA203505",
  "marketing_category": "NDA"
}

See everything about ospemifene.

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.