United States· US:61958-2501_250704ed-23f6-4ac2-8f0a-31c6d7d95821
Biktarvy
A emtricitabine, tenofovir alafenamide and bictegravir product containing bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate, registered in United States by Gilead Sciences, 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 alafenamide and bictegravir is registered in 13 of 19 countries.
Countries holding a registration under ATC J05AR20 (emtricitabine, tenofovir alafenamide and bictegravir), 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 bictegravir · ATC J05AR20
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
- BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
- Manufacturer
- Gilead Sciences, Inc.
- Country
- United States (US)
- ATC code
- J05AR20
- ATC class
- Emtricitabine, tenofovir alafenamide and bictegravir
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 13, 2026
Packs & prices · 4
- ndc1161958-2501-1
- ndc1161958-2501-2
- ndc1161958-2501-3
- ndc1161958-2501-5
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Emtricitabine, tenofovir alafenamide and bictegravir in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaBIKTARVYGILEAD SCIENCES CANADA INC
- FinlandBiktarvyGilead Sciences Ireland UC
- CzechiaBIKTARVYGilead Sciences Ireland UC, Carrigtohill
- SpainBIKTARVY 50 MG/200 MG/25 MG COMPRIMIDOS RECUBIERTOS CON PELICULAGilead Sciences Ireland Unlimited Company
- IcelandBiktarvyGilead Sciences Ireland UC*
- NorwayBiktarvyGilead Sciences Ireland UC
- PolandBiktarvyGilead Sciences Ireland UC
- SwedenBiktarvy 30 mg/120 mg/15 mg Filmdragerad tablettGilead Sciences Ireland UC
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Biktarvy
- Liechtenstein · Biktarvy
- Norway · Biktarvy
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/c0f82d55-6154-4f48-8dc0-6920df78538f GET /v1/drugs/c0f82d55-6154-4f48-8dc0-6920df78538f?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": "50; 200; 25",
"substance": "BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE",
"productndc": "61958-2501",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1; mg/1",
"application_number": "NDA210251",
"marketing_category": "NDA"
}See everything about emtricitabine, tenofovir alafenamide and bictegravir.
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.