United States· US:61958-1803_6fc15183-879a-4402-af66-edf57754e31f
Harvoni
A sofosbuvir and ledipasvir product containing ledipasvir; sofosbuvir, 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
Sofosbuvir and ledipasvir is registered in 13 of 19 countries.
Countries holding a registration under ATC J05AP51 (sofosbuvir and ledipasvir), 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
Sofosbuvir and ledipasvir · ATC J05AP51
13 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- LEDIPASVIR; SOFOSBUVIR
- Manufacturer
- Gilead Sciences, Inc
- Country
- United States (US)
- ATC code
- J05AP51
- ATC class
- Sofosbuvir and ledipasvir
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1161958-1803-1
- ndc11619581803128 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1803-1)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sofosbuvir and ledipasvir in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaHARVONIGilead Sciences Ireland UC, Carrigtohill
- PolandHarvoniGilead Sciences Ireland UC
- IcelandHarvoniGilead Sciences Ireland UC*
- NetherlandsHarvoni 33,75 mg/150 mg, granulaatGilead Sciences Ireland UC
- SwedenHarvoni 33,75 mg/150 mg Dragerat granulat i dospåseGilead Sciences Ireland UC
- FinlandHarvoniGilead Sciences Ireland UC
- United KingdomHarvoni 33.75mg/150mg granules sachetsGilead Sciences Ltd
- IrelandHarvoni 33.75 mg/150 mg Coated granulesGilead Sciences Ireland UC
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Harvoni
- Liechtenstein · Harvoni
- Norway · Harvoni
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/e69253e8-a69d-4c24-9007-09ee42a34410 GET /v1/drugs/e69253e8-a69d-4c24-9007-09ee42a34410?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": "45; 200",
"substance": "LEDIPASVIR; SOFOSBUVIR",
"productndc": "61958-1803",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "NDA205834",
"marketing_category": "NDA"
}See everything about sofosbuvir and ledipasvir.
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.