Trikafta
- Product NDC
- 51167-445
- 11-digit product format
- 511670445
- Labeler code
- 51167
- Product ID
- 51167-445_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
openFDA Listing Details
- Product ID
- 51167-445_d16848f4-2958-44c0-b688-8a9b25d9032f
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Trikafta
- Generic name
- Elexacaftor, Tezacaftor, and Ivacaftor
- Dosage form
- KIT
- Marketing start
- 2023-04-26
- Marketing category
- NDA
- Application number
- NDA217660
- Listing expiration
- 2027-12-31
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Rxcui | 1243046, 1606868, 2174388, 2257011, 2257012, 2257013, 2557214, 2557215, 2557216, 2635013, 2635020, 2635021, 2635022, 2635024, 2635025, 2635026 |
| Spl Set Id | f354423a-85c2-41c3-a9db-0f3aee135d8d |
| Manufacturer Name | Vertex Pharmaceuticals Incorporated |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51167-445-01 | 51167044501 | 4 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) | 4 package | 2023-04-26 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Trikafta | Vertex Pharmaceuticals Incorporated | 2026-03-23 | HUMAN PRESCRIPTION DRUG LABEL | 22 |