1. Home
  2. Labeler Index
  3. Qed Therapeutics, Inc.
  4. NDC Product Code: 72730-111 Truseltiq

NDC 72730-111 Truseltiq

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 72730-111?
  5. Truseltiq Uses
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
72730-111
Proprietary Name:
Truseltiq
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Qed Therapeutics, Inc.
Labeler Code:
72730
Product Label ID:
af9a96cf-1cd7-8ace-e053-2a95a90a18cc
Start Marketing Date: [9]
05-28-2021
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
ORANGE (C48331)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
INFI100MG
Score:
1

Code Structure Chart

Product Details

What is NDC 72730-111?

The NDC code 72730-111 is assigned by the FDA to the product Truseltiq which is product labeled by Qed Therapeutics, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 72730-111-01 1 blister pack in 1 carton / 21 capsule 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 Truseltiq?

TRUSELTIQ is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test [see Dosage and Administration ( 2.1)] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.1)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Which are Truseltiq UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Truseltiq?

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:

* Please review the disclaimer below.

Patient Education

Infigratinib


Infigratinib is used in adults who have received previous therapy to treat a certain type of cholangiocarcinoma (bile duct cancer) that has spread to nearby tissues or other parts of the body and cannot be removed by surgery. Infigratinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

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

[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".