NDC 51167-113 Symdeko

Tezacaftor And Ivacaftor Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

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
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Vertex Pharmaceuticals Incorporated
Labeler Code:
51167
FDA Application Number: [6]
NDA210491
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
06-21-2019
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330)
BLUE (C48333)
WHITE (C48325)
Shape:
CAPSULE (C48336)
OVAL (C48345)
Size(s):
16 MM
17 MM
13 MM
Imprint(s):
V100
V;150
V50
V;75
Score:
1

Product Packages

NDC Code 51167-113-01

Package Description: 1 KIT in 1 CARTON * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK

Product Details

What is NDC 51167-113?

The NDC code 51167-113 is assigned by the FDA to the product Symdeko which is a human prescription drug product labeled by Vertex Pharmaceuticals Incorporated. The generic name of Symdeko is tezacaftor and ivacaftor. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 51167-113-01 1 kit in 1 carton * 7 tablet, film coated in 1 blister pack * 7 tablet, film coated in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Symdeko?

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 Symdeko UNII Codes?

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

Which are Symdeko Inactive Ingredients 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 Symdeko?

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 disclaimer below.

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 disclaimer below.

Product Footnotes

[1] 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.

[3] 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.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".