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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

  • ndc11
    5116710602
    4 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
}

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