United States· US:51167-331_d16848f4-2958-44c0-b688-8a9b25d9032f
Trikafta
A medicinal product containing elexacaftor, tezacaftor, and ivacaftor, registered in United States by Vertex Pharmaceuticals Incorporated.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- Elexacaftor, Tezacaftor, and Ivacaftor
- Manufacturer
- Vertex Pharmaceuticals Incorporated
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- June 3, 2026
Packs & prices · 1
- ndc1151167331014 BLISTER PACK in 1 CARTON (51167-331-01) / 1 KIT in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK (51167-431-14) * 7 TABLET, FILM COATED in 1 BLISTER PACK (51167-531-07)
Regulatory notes
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/e39c8401-a335-4fc6-bab3-45f09414eba7 GET /v1/drugs/e39c8401-a335-4fc6-bab3-45f09414eba7?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": null,
"spl_meta": {
"f354423a-85c2-41c3-a9db-0f3aee135d8d": {
"match": "brand_token",
"title": "TRIKAFTA (ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR) KIT [VERTEX PHARMACEUTICALS INCORPORATED]",
"spl_version": "22",
"published_date": "2026-04-08"
}
},
"productid": "51167-331_d16848f4-2958-44c0-b688-8a9b25d9032f",
"productndc": "51167-331",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "212273",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG,75MG,50MG; 150MG",
"product_no": "001",
"approval_date": "Oct 21, 2019"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "50MG,37.5MG,25MG; 75MG",
"product_no": "002",
"approval_date": "Jun 8, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Trikafta",
"active_ingred_unit": null,
"application_number": "NDA212273",
"marketing_category": "NDA",
"nonproprietary_name": "Elexacaftor, Tezacaftor, and Ivacaftor",
"start_marketing_date": "20191021",
"active_numerator_strength": null
}See everything about elexacaftor, tezacaftor, and ivacaftor.
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.