Symdeko Kit
NDC 51167-113

Kit
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 51167-113?
  5. Symdeko Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

Symdeko (tezacaftor and ivacaftor) is a NDA-approved product labeled by Vertex Pharmaceuticals Incorporated. This product contains 2 different tablets. It is supplied as a kit. This product entry covers the primary NDC 51167-113 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
51167-113
Proprietary Name:
Symdeko
Non-Proprietary Name: [1]
Tezacaftor And Ivacaftor
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Vertex Pharmaceuticals Incorporated
Labeler Code:
51167
Product Label ID:
302ae804-37db-44fd-ac2f-3dbdeda9aa4b
FDA Application Number: [6]
NDA210491
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
06-21-2019
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
Tezacaftor and Ivacaftor: WHITE (C48325)
Ivacaftor: BLUE (C48333)
Shape:
Tezacaftor and Ivacaftor: CAPSULE (C48336)
Ivacaftor: CAPSULE (C48336)
Size(s):
Tezacaftor and Ivacaftor: 13 MM
Ivacaftor: 13 MM
Imprint(s):
Tezacaftor and Ivacaftor: V50
Ivacaftor: V;75
Score:
Tezacaftor and Ivacaftor: 1
Ivacaftor: 1

Code Structure Chart

Product Details

What is NDC 51167-113?

The NDC code 51167-113 is assigned by the FDA to the product Symdeko. It is commonly known by its generic name, tezacaftor and ivacaftor. This pharmaceutical product is labeled by Vertex Pharmaceuticals Incorporated and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 51167-113-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This product contains 2 different tablets. One tablet contains 2 medications ("multi-drug"): tezacaftor and ivacaftor. The other tablet contains only ivacaftor. This product is used to treat cystic fibrosis in certain people (those with an abnormal "CFTR" gene). It may help to improve breathing, reduce the risk of lung infections, and improve weight gain.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1243046 - ivacaftor 150 MG Oral Tablet
  • RxCUI: 1999387 - ivacaftor 150 MG / tezacaftor 100 MG Oral Tablet
  • RxCUI: 1999388 - {28 (ivacaftor 150 MG / tezacaftor 100 MG Oral Tablet) / 28 (ivacaftor 150 MG Oral Tablet) } Pack
  • RxCUI: 1999388 - ivacaftor 150 MG / tezacaftor 100 MG (28) Oral Tablet / ivacaftor 150 MG (28) Oral Tablet Pack
  • RxCUI: 1999389 - {28 (ivacaftor 150 MG / tezacaftor 100 MG Oral Tablet) / 28 (ivacaftor 150 MG Oral Tablet) } Pack [Symdeko (100 MG / 150 MG; 150 MG)]

* Please review the full disclaimer at the bottom of this page.

Patient Education

Ivacaftor


Ivacaftor is used to treat certain types of cystic fibrosis (an inborn disease that causes problems with breathing, digestion, and reproduction) in adults and children 4 months of age and older. Ivacaftor should be used only in people with a certain genetic make-up. Your doctor may order a blood test to help decide if this medication is right for you. Ivacaftor is in a class of medications called cystic fibrosis transmembrane conductance regulator (CFTR) potentiators. It works by improving the function of a protein in the body to decrease the build-up of thick mucus in the lungs and improving other symptoms of cystic fibrosis.
[Learn More]


Tezacaftor and Ivacaftor


The combination of tezacaftor and ivacaftor is used along with ivacaftor to treat certain types of cystic fibrosis (an inborn disease that causes problems with breathing, digestion, and reproduction) in adults and children 6 years of age and older. Tezacaftor and ivacaftor should be used only in people with a certain genetic make-up. Your doctor may order a blood test to help decide if this medication is right for you. Tezacaftor is in a class of medications called cystic fibrosis transmembrane conductance regulator (CFTR) correctors. Ivacaftor is in a class of medications called cystic fibrosis transmembrane conductance regulator (CFTR) potentiators. Both of these medications work by improving the function of a protein in the body to decrease the build-up of thick mucus in the lungs and improve other cystic fibrosis symptoms.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".