Prescription drug · NDA
Alyftrek NDC 51167-135
vanzacaftor, tezacaftor, and deutivacaftor · Vanzacaftor 4 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Vertex Pharmaceuticals Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51167-135-01 | 51167013501 | 4 BLISTER PACK in 1 CARTON (51167-135-01) / 21 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 20, 2024 |
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)
- Alyftrek
- Generic name (nonproprietary)
- vanzacaftor, tezacaftor, and deutivacaftor
- Active ingredients
- Vanzacaftor — 4 mg/1Tezacaftor — 20 mg/1Deutivacaftor — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Vertex Pharmaceuticals IncorporatedNDC labeler code 51167
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218730
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Chloride Channel Activation Potentiators (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 51167-135_fe5c4f96-377c-455b-896c-4886c10d5098SPL ID fe5c4f96-377c-455b-896c-4886c10d5098SPL set ID 7e635909-c6fd-4f0d-ae77-cdff03653a20RxCUI 2701438, 2701444, 2701448, 2701450UNII 8RW88Y506K, SHA6U5FJZL, COM1POP492
- Pharmacologic class
- Cystic Fibrosis Transmembrane Conductance Regulator Potentiator
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N451167013501followed by a unit qualifier and the quantityPackage 51167-0135-01. 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)
ALYFTREK is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients 6 years of age 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 5 ) 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. ALYFTREK is a combinat…
Excerpt only. Read the full label for complete information.
About NDC 51167-135
- What is NDC 51167-135?
- 51167-135 is the product NDC for Alyftrek, Vanzacaftor 4 mg/1 + 2 more ingredients tablet, film coated, 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?
- Alyftrek (Vanzacaftor, tezacaftor, and deutivacaftor).
- What is the active ingredient?
- Vanzacaftor, Tezacaftor, Deutivacaftor.
- 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 Alyftrek?
- 1 other product NDC are listed under this name. See all Alyftrek NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alyftrek products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alyftrekvanzacaftor, tezacaftor, and deutivacaftor | Vanzacaftor 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Vertex Pharmaceuticals Incorporated | 51167-121 | 51167-0121-01 |
Other NDCs under NDA 218730
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 |
|---|---|---|---|---|
| Alyftrekvanzacaftor, tezacaftor, and deutivacaftor | Vanzacaftor 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Vertex Pharmaceuticals Incorporated | 51167-121 |