United States· US:61958-2101_130b8bbc-f660-40ff-831c-139734f90b99

ODEFSEY

A emtricitabine, tenofovir alafenamide and rilpivirine product containing emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate, registered in United States by Gilead Sciences, Inc.. The same ATC class is registered in 13 of our 19 countries.

ATC J05AR19US 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…normalisedODEFSEYATCJ05AR19REGISTER NO.US:61958-2101_130b8bb…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Emtricitabine, tenofovir alafenamide and rilpivirine is registered in 13 of 19 countries.

Countries holding a registration under ATC J05AR19 (emtricitabine, tenofovir alafenamide and rilpivirine), each read from that country’s own register.

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

Emtricitabine, tenofovir alafenamide and rilpivirine · ATC J05AR19

13 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • 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
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
Manufacturer
Gilead Sciences, Inc.
Country
United States (US)
ATC code
J05AR19
ATC class
Emtricitabine, tenofovir alafenamide and rilpivirine
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    61958-2101-1
  • ndc11
    6195821011
    30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1)

Regulatory notes

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

Same medicine, other countries

Emtricitabine, tenofovir alafenamide and rilpivirine in 13 other countries

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

All emtricitabine, tenofovir alafenamide and rilpivirine products

Authorised across Europe · EMA

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

  • Iceland · Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris, Odefsey
  • Liechtenstein · Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris, Odefsey
  • Norway · Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris, Odefsey

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/b51ab395-b7a0-4108-91cd-2fac57346c7b
GET /v1/drugs/b51ab395-b7a0-4108-91cd-2fac57346c7b?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": "200; 25; 25",
  "substance": "EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE",
  "productndc": "61958-2101",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA208351",
  "marketing_category": "NDA"
}

See everything about emtricitabine, tenofovir alafenamide and rilpivirine.

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.