NDC codes

FDA NDC Directory
Product NDC (as listed)51167-135Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51167-0135Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
51167-135-01511670135014 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

N451167013501 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Alyftrek NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Alyftrekvanzacaftor, tezacaftor, and deutivacaftorVanzacaftor 10 mg/1 + 2 more ingredientsTablet, Film coatedOralVertex Pharmaceuticals Incorporated51167-12151167-0121-01

Other NDCs under NDA 218730

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 218730
ProductStrengthForm · routeLabelerProduct NDC
Alyftrekvanzacaftor, tezacaftor, and deutivacaftorVanzacaftor 10 mg/1 + 2 more ingredientsTablet, Film coatedOralVertex Pharmaceuticals Incorporated51167-121

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