NDC 0053-0350 Hemgenix

Etranacogene Dezaparvovec Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0053-0350
Proprietary Name:
Hemgenix
Non-Proprietary Name: [1]
Etranacogene Dezaparvovec
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]
Labeler Code:
0053
FDA Application Number: [6]
BLA125772
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
11-22-2022
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Navigator:

Code Structure Chart

Product Details

What is NDC 0053-0350?

The NDC code 0053-0350 is assigned by the FDA to the product Hemgenix which is a human prescription drug product labeled by Csl Behring. The generic name of Hemgenix is etranacogene dezaparvovec. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0053-0350-35 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass (0053-0099-01). 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 Hemgenix?

HEMGENIX is an adeno-associated virus vector-based gene therapy indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who:Currently use Factor IX prophylaxis therapy, orHave current or historical life-threatening hemorrhage, orHave repeated, serious spontaneous bleeding episodes.

Which are Hemgenix UNII Codes?

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

  • ETRANACOGENE DEZAPARVOVEC (UNII: Z5XCD5Q9RL)
  • ETRANACOGENE DEZAPARVOVEC (UNII: Z5XCD5Q9RL) (Active Moiety)

What is the NDC to RxNorm Crosswalk for Hemgenix?

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: 2626772 - etranacogene dezaparvovec-drlb 100000000000000 VECTOR-GENOMES in 10 ML Injection
  • RxCUI: 2626772 - 10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection
  • RxCUI: 2626772 - etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML per 10 ML Injection
  • RxCUI: 2626772 - etranacogene dezaparvovec-drlb 100000000000000 VECTOR-GENOMES per 10 ML Injection
  • RxCUI: 2626778 - HEMGENIX 100000000000000 VECTOR-GENOMES in 10 ML Injection

* 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".