Prescription drug · NDA
Trikafta (Elexacaftor, tezacaftor, and ivacaftor) NDC 51167-106
Kit · Vertex Pharmaceuticals Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51167-106-02 | 51167010602 | 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)Marketed from Jun 8, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Trikafta
- Generic name (nonproprietary)
- elexacaftor, tezacaftor, and ivacaftor
- Dosage form
- Kit
- Labeler
- Vertex Pharmaceuticals IncorporatedNDC labeler code 51167
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212273
- Marketing start
- Listing expires
- Identifiers
- Product ID 51167-106_b63ac090-8d8b-43a0-82d1-558127f2d598SPL ID b63ac090-8d8b-43a0-82d1-558127f2d598SPL set ID f354423a-85c2-41c3-a9db-0f3aee135d8dRxCUI 1243046, 1606868, 2174388, 2257011, 2257012, 2257013, 2557214, 2557215, 2557216, 2635013, 2635020, 2635021, 2635022, 2635024, 2635025, 2635026
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N451167010602followed by a unit qualifier and the quantityPackage 51167-0106-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients aged 2 years and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is either responsive based on clinical and/or in vitro data (see Table 6 ) or results in production of CFTR protein [see Clinical Pharmacology (12.1) ] . If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. TRIKAFTA is a combinati…
Excerpt only. Read the full label for complete information.
About NDC 51167-106
- What is NDC 51167-106?
- 51167-106 is the product NDC for Trikafta kit, listed with the FDA by Vertex Pharmaceuticals Incorporated. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Trikafta (Elexacaftor, Tezacaftor, and Ivacaftor).
- Who is the labeler?
- Vertex Pharmaceuticals Incorporated, NDC labeler code 51167. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Trikafta?
- 3 other product NDCs are listed under this name. See all Trikafta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Trikafta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Trikaftaelexacaftor, tezacaftor, and ivacaftor | — | Kit | Vertex Pharmaceuticals Incorporated | 51167-445 | 51167-0445-01 |
| Trikaftaelexacaftor, tezacaftor, and ivacaftor | — | Kit | Vertex Pharmaceuticals Incorporated | 51167-446 | 51167-0446-01 |
| Trikaftaelexacaftor, tezacaftor, and ivacaftor | — | Kit | Vertex Pharmaceuticals Incorporated | 51167-331 | 51167-0331-01 |
Other NDCs under NDA 212273
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Trikaftaelexacaftor, tezacaftor, and ivacaftor | — | Kit | Vertex Pharmaceuticals Incorporated | 51167-331 |