Prescription drug · NDA
Symdeko (Tezacaftor and ivacaftor) NDC 51167-113
Kit · Vertex Pharmaceuticals Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51167-113-01 | 51167011301 | 1 KIT in 1 CARTON (51167-113-01) * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 21, 2019 |
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)
- Symdeko
- Generic name (nonproprietary)
- tezacaftor and ivacaftor
- Dosage form
- Kit
- Labeler
- Vertex Pharmaceuticals IncorporatedNDC labeler code 51167
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210491
- Marketing start
- Listing expires
- Identifiers
- Product ID 51167-113_c3cdc7ce-9aa2-469f-8212-13fedd450630SPL ID c3cdc7ce-9aa2-469f-8212-13fedd450630SPL set ID 302ae804-37db-44fd-ac2f-3dbdeda9aa4bRxCUI 1243046, 1999387, 1999388, 1999389, 2174387, 2174388, 2174389, 2174390
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
N451167011301followed by a unit qualifier and the quantityPackage 51167-0113-01. 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)
SYMDEKO is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence [see Clinical Pharmacology (12.1) and Clinical Studies (14) ] . If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use. SYMDEKO is a combination of tezacaftor and ivacaftor,…
Excerpt only. Read the full label for complete information.
About NDC 51167-113
- What is NDC 51167-113?
- 51167-113 is the product NDC for Symdeko 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?
- Symdeko (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 Symdeko?
- 1 other product NDC are listed under this name. See all Symdeko NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Symdeko products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Symdekotezacaftor and ivacaftor | — | Kit | Vertex Pharmaceuticals Incorporated | 51167-661 | 51167-0661-01 |
Other NDCs under NDA 210491
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 |
|---|---|---|---|---|
| Symdekotezacaftor and ivacaftor | — | Kit | Vertex Pharmaceuticals Incorporated | 51167-661 |