Prescription drug · NDA
Orkambi (Lumacaftor and ivacaftor) NDC 51167-809
Lumacaftor 200 mg/1; Ivacaftor 125 mg/1 · Tablet, Film coated · Oral · Vertex Pharmaceuticals Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51167-809-01 | 51167080901 | 4 CARTON in 1 BOX (51167-809-01) / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 2, 2015 |
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)
- Orkambi
- Generic name (nonproprietary)
- lumacaftor and ivacaftor
- Active ingredients
- Lumacaftor — 200 mg/1Ivacaftor — 125 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 206038
- Marketing start
- Listing expires
- Other FDA classes
- Chloride Channel Activation Potentiators (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C8 Inducers (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)P-Glycoprotein Inducers (Mechanism)P-Glycoprotein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 51167-809_e746b83a-cec1-40ab-8dba-7d8c1781e8b1SPL ID e746b83a-cec1-40ab-8dba-7d8c1781e8b1SPL set ID 3fc1c40e-cfac-47a1-9e1a-61ead3570600RxCUI 1655928, 1655934, 1812468, 1812470, 2053509, 2053512, 2053517, 2053519, 2611458, 2611460UNII EGP8L81APK, 1Y740ILL1Z
- 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
N451167080901followed by a unit qualifier and the quantityPackage 51167-0809-01. 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 .
Indications (excerpt from the label)
ORKAMBI is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene. ORKAMBI is a combination of ivacaftor, a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, and lumacaftor, indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the…
Excerpt only. Read the full label for complete information.
About NDC 51167-809
- What is NDC 51167-809?
- 51167-809 is the product NDC for Orkambi, Lumacaftor 200 mg/1; Ivacaftor 125 mg/1 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?
- Orkambi (Lumacaftor and ivacaftor).
- What is the active ingredient?
- Lumacaftor, 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 Orkambi?
- 4 other product NDCs are listed under this name. See all Orkambi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Orkambi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Orkambilumacaftor and ivacaftor | Lumacaftor 75 mg/1; Ivacaftor 94 mg/1 | GranuleOral | Vertex Pharmaceuticals Incorporated | 51167-122 | 51167-0122-01 |
| Orkambilumacaftor and ivacaftor | Lumacaftor 150 mg/1; Ivacaftor 188 mg/1 | GranuleOral | Vertex Pharmaceuticals Incorporated | 51167-500 | 51167-0500-02 |
| Orkambilumacaftor and ivacaftor | Lumacaftor 100 mg/1; Ivacaftor 125 mg/1 | GranuleOral | Vertex Pharmaceuticals Incorporated | 51167-900 | 51167-0900-01 |
| Orkambilumacaftor and ivacaftor | Lumacaftor 100 mg/1; Ivacaftor 125 mg/1 | Tablet, Film coatedOral | Vertex Pharmaceuticals Incorporated | 51167-700 | 51167-0700-02 |
Other NDCs under NDA 206038
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 |
|---|---|---|---|---|
| Orkambilumacaftor and ivacaftor | Lumacaftor 100 mg/1; Ivacaftor 125 mg/1 | Tablet, Film coatedOral | Vertex Pharmaceuticals Incorporated | 51167-700 |