United States· US:51167-700_e746b83a-cec1-40ab-8dba-7d8c1781e8b1
ORKAMBI
A ivacaftor and lumacaftor product containing lumacaftor; ivacaftor, registered in United States by Vertex Pharmaceuticals Incorporated. The same ATC class is registered in 16 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Ivacaftor and lumacaftor is registered in 16 of 19 countries.
Countries holding a registration under ATC R07AX30 (ivacaftor and lumacaftor), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 11 of them publish a price we can compare per daily dose
Ivacaftor and lumacaftor · ATC R07AX30
16 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Italyprice
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- LUMACAFTOR; IVACAFTOR
- Manufacturer
- Vertex Pharmaceuticals Incorporated
- Country
- United States (US)
- ATC code
- R07AX30
- ATC class
- Ivacaftor and lumacaftor
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1151167700024 CARTON in 1 BOX (51167-700-02) / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1151167-700-02
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ivacaftor and lumacaftor in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaORKAMBIVertex Pharmaceuticals (Ireland) Limited, Dublin
- PolandOrkambiVertex Pharmaceuticals (Ireland) Limited
- CanadaORKAMBIVERTEX PHARMACEUTICALS (CANADA) INCORPORATED
- SwitzerlandOrkambi 100 mg / 125 mg, FilmtablettenVertex Pharmaceuticals (CH) GmbH
- SpainORKAMBI 100 MG/125 MG COMPRIMIDOS RECUBIERTOS CON PELICULAVertex Pharmaceuticals (Ireland) Limited
- FinlandOrkambiVertex Pharmaceuticals (Ireland) Limited
- FranceORKAMBI 100 mg/125 mg, comprimé pelliculéVERTEX PHARMACEUTICALS (IRELAND)
- United KingdomOrkambi 100mg/125mg granules sachetsVertex Pharmaceuticals (Europe) Ltd
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Orkambi
- Liechtenstein · Orkambi
- Norway · Orkambi
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/431f225d-2b33-4ea2-9493-a40b18b698ef GET /v1/drugs/431f225d-2b33-4ea2-9493-a40b18b698ef?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": "100; 125",
"substance": "LUMACAFTOR; IVACAFTOR",
"productndc": "51167-700",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "NDA206038",
"marketing_category": "NDA"
}See everything about ivacaftor and lumacaftor.
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.