Trikafta

Product NDC
51167-446
11-digit product format
511670446
Labeler code
51167
Product ID
51167-446_d16848f4-2958-44c0-b688-8a9b25d9032f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Elexacaftor, Tezacaftor, and Ivacaftor
Dosage form
KIT
Labeler
Vertex Pharmaceuticals Incorporated
Application
NDA217660
Marketing category
NDA
Marketing start
2023-04-26
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51167-446-01511670446014 PACKAGE in 1 CARTON (51167-446-01) / 1 KIT in 1 PACKAGE * 1 GRANULE in 1 PACKET (51167-746-07) * 1 GRANULE in 1 PACKET (51167-846-07) 4 package2023-04-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TrikaftaVertex Pharmaceuticals Incorporated2026-03-23HUMAN PRESCRIPTION DRUG LABEL22
TrikaftaVertex Pharmaceuticals Incorporated2025-02-12HUMAN PRESCRIPTION DRUG LABEL20