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United States · US · US:51167-106_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
- ndc1151167106024 BLISTER PACK in 1 CARTON (51167-106-02) / 1 KIT in 1 BLISTER PACK * 14 TABLET, FILM COATED in 1 BLISTER PACK (51167-206-14) * 7 TABLET, FILM COATED in 1 BLISTER PACK (51167-306-07)
Annotations
Orange Book
N212273
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": "51167-106_d16848f4-2958-44c0-b688-8a9b25d9032f",
"productndc": "51167-106",
"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": "20210608",
"active_numerator_strength": null
}Access this data programmatically
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