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United States· US:42543-719_427e3960-fb3a-429d-8651-b62e7b97479d

Emtricitabine and Tenofovir Disoproxil Fumarate

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

ATC J05AR03US 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…normalisedEmtricitabine and Tenofovir Disoproxi…ATCJ05AR03REGISTER NO.US:42543-719_427e3960…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Tenofovir disoproxil and emtricitabine is registered in 13 of 19 countries.

Countries holding a registration under ATC J05AR03 (tenofovir disoproxil and emtricitabine), 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

Tenofovir disoproxil and emtricitabine · ATC J05AR03

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; TENOFOVIR DISOPROXIL FUMARATE
Manufacturer
Strides Pharma Inc.
Country
United States (US)
ATC code
J05AR03
ATC class
Tenofovir disoproxil and emtricitabine
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    42543-719-04
  • ndc11
    4254371904
    30 TABLET in 1 BOTTLE, PLASTIC (42543-719-04)

Regulatory notes

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

Interactions

9 interactions on record for tenofovir disoproxil and emtricitabine.

Mechanism, severity and management for each pair, from a commercially licensed source — included 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

Tenofovir disoproxil and emtricitabine · interactions on record

9 records

9 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
Mechanism and what to do, in the interaction check
Interaction register. Grades as the source publishes them.

Same medicine, other countries

Tenofovir disoproxil and emtricitabine in 12 other countries

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

All tenofovir disoproxil and emtricitabine products

Authorised across Europe · EMA

The same active substance is authorised in 26 EEA countries. Names it is sold under:

  • Austria · Emtricitabin/Tenofovir Sandoz, Emtricitabin/Tenofovirdisoproxil Stada
  • Belgium · Emtricitabin/Tenofovir Disoproxil Ab
  • Cyprus · Exatron
  • Germany · Emtenovo, Emtricitabin Tenofovirdisoproxil Zentiva
  • Denmark · Emtricitabin/Tenofovirdisoproxil Tillomed, Emtricitabine/Tenofovir Disoproxil "sandoz"
  • Estonia · Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Sandoz
  • Spain · Emtricitabina/Tenofovir Disoproxilo Aurovitas, Emtricitabina/Tenofovir Disoproxilo Glenmark
  • Finland · Emtricitabine / Tenofovir Disoproxil Stada, Emtricitabine/Tenofovir Disoproxil Accordpharma
  • France · Emtricitabine/ Tenofovir Disoproxil Sandoz, Emtricitabine/Tenofovir Disoproxil Accord
  • United Kingdom (Northern Ireland) · Emtricitabin/Tenofovirdisoproxil Amarox, Emtricitabine/ Tenofovir Disoproxil
  • Greece · Argiodin, Emtricitabin/Tenofovir Disoproxil Accord
  • Croatia · Emtricitabin/Tenofovirdizoproksil Pliva
  • Hungary · Dunotrisin, Emtricitabine/Tenofovir Disoproxil Accordpharma
  • Ireland · Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Clonmel
  • Iceland · Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Krka
  • Italy · Emtricitabina E Tenofovir Disoproxil Aequilibrium Pharma, Emtricitabina E Tenofovir Disoproxil Aurobindo
  • Liechtenstein · Emtricitabine/Tenofovir Disoproxil Mylan, Emtricitabine/Tenofovir Disoproxil Zentiva
  • Lithuania · Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Sandoz
  • Latvia · Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Teva
  • Netherlands · Emtricitabine Tenofovir Disoproxyl Fumarate Aurobindo, Emtricitabine/Tenofovir Disoproxil Accordpharma
  • Norway · Emtricitabin/Tenofovirdisoproxil Tillomed, Emtricitabine/ Tenofovir Disoproxil Cipla
  • Poland · Emtricitabine + Tenofovir Disoproxil Aurovitas, Emtricitabine + Tenofovir Disoproxil Tillomed
  • Portugal · Emtricitabina + Tenofovir Accord, Emtricitabina + Tenofovir Disoproxil
  • Romania · Emtricitabină/Tenofovir Disoproxil Stada, Emtricitabină/Tenofovir Disoproxil Teva
  • Sweden · Emtricitabine/Tenofovir Disoproxil Accordpharma, Emtricitabine/Tenofovir Disoproxil Glenmark
  • Slovenia · Emtricitabin/Dizoproksiltenofovirat Teva

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/211dbb18-d112-4f0e-9b6e-6eb22b70408f
GET /v1/drugs/211dbb18-d112-4f0e-9b6e-6eb22b70408f?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; 300",
  "substance": "EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
  "productndc": "42543-719",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA091055",
  "marketing_category": "ANDA"
}

See everything about tenofovir disoproxil and emtricitabine.

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.