United States· US:0378-5440_d9a4185e-43fa-4aeb-9b0f-8db01b166038
Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate
A emtricitabine, tenofovir disoproxil and rilpivirine product containing emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate, registered in United States by Mylan Pharmaceuticals Inc.. The same ATC class is registered in 13 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
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
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
- Manufacturer
- Mylan Pharmaceuticals 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
- ndc11037854409330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5440-93)
- ndc110378-5440-93
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.
- FinlandEvipleraAbacus Medicine A/S
- NorwayEviplera2care4 ApS
- CzechiaEVIPLERAGilead Sciences Ireland UC, Carrigtohill
- CanadaCOMPLERAGILEAD SCIENCES CANADA INC
- IcelandEvipleraGilead Sciences Ireland UC*
- PolandEvipleraGilead Sciences Ireland UC
- SwedenEviplera 200 mg/25 mg/245 mg Filmdragerad tablettGilead Sciences Ireland UC
- IrelandEviplera 200 mg/25 mg/245 mg film-coated tabletsGilead Sciences Ireland UC
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/7658abba-7aff-41c0-9d15-3765804dabae GET /v1/drugs/7658abba-7aff-41c0-9d15-3765804dabae?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": "0378-5440",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1; mg/1",
"application_number": "ANDA208452",
"marketing_category": "ANDA"
}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.