United States· US:61958-1101_21d7850d-11ea-43cc-84a5-0dae02a19ce6

COMPLERA

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

ATC J05AR08US 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…normalisedCOMPLERAATCJ05AR08REGISTER NO.US:61958-1101_21d7850…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

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

Countries holding a registration under ATC J05AR08 (emtricitabine, tenofovir disoproxil 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 disoproxil and rilpivirine · ATC J05AR08

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 DISOPROXIL FUMARATE
Manufacturer
Gilead Sciences, Inc.
Country
United States (US)
ATC code
J05AR08
ATC class
Emtricitabine, tenofovir disoproxil 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
    6195811011
    30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1)
  • ndc11
    61958-1101-1

Regulatory notes

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

Same medicine, other countries

Emtricitabine, tenofovir disoproxil and rilpivirine in 11 other countries

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

All emtricitabine, tenofovir disoproxil and rilpivirine products

Authorised across Europe · EMA

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

  • Iceland · Eviplera
  • Liechtenstein · Eviplera
  • Norway · Eviplera

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/8c9497fe-46e1-4b09-90d1-12c530312ac6
GET /v1/drugs/8c9497fe-46e1-4b09-90d1-12c530312ac6?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; 300",
  "substance": "EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE",
  "productndc": "61958-1101",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA202123",
  "marketing_category": "NDA"
}

See everything about emtricitabine, tenofovir disoproxil 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.