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United States · US · US:51167-445_d16848f4-2958-44c0-b688-8a9b25d9032f
Trikafta
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerVertex Pharmaceuticals Incorporated
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1151167445014 PACKAGE in 1 CARTON (51167-445-01) / 1 KIT in 1 PACKAGE * 1 GRANULE in 1 PACKET (51167-545-07) * 1 GRANULE in 1 PACKET (51167-645-07)
Annotations
Orange Book
N217660
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"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": "51167-445_d16848f4-2958-44c0-b688-8a9b25d9032f",
"productndc": "51167-445",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "217660",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "80MG, 60MG, 40MG;59.5MG",
"product_no": "001",
"approval_date": "Apr 26, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG, 75MG, 50MG;75MG",
"product_no": "002",
"approval_date": "Apr 26, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Trikafta",
"active_ingred_unit": null,
"application_number": "NDA217660",
"marketing_category": "NDA",
"nonproprietary_name": "Elexacaftor, Tezacaftor, and Ivacaftor",
"start_marketing_date": "20230426",
"active_numerator_strength": null
}Access this data programmatically
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