NDC Package 0053-0170-17 Hemgenix

Etranacogene Dezaparvovec Kit - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0053-0170-17
Package Description:
1 KIT in 1 CARTON * 1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01)
Product Code:
Proprietary Name:
Hemgenix
Non-Proprietary Name:
Etranacogene Dezaparvovec
Usage Information:
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.
11-Digit NDC Billing Format:
00053017017
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • 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
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Csl Behring
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    BLA125772
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    11-22-2022
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0053-0170-17 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00053017017J1411Inj, hemgenix, per tx dosePer Therapeutic Dose101711

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0053-0170-17?

    The NDC Packaged Code 0053-0170-17 is assigned to a package of 1 kit in 1 carton * 1 injection, suspension in 1 vial, glass (0053-0099-01) of Hemgenix, a human prescription drug labeled by Csl Behring. The product's dosage form is kit and is administered via form.

    Is NDC 0053-0170 included in the NDC Directory?

    Yes, Hemgenix with product code 0053-0170 is active and included in the NDC Directory. The product was first marketed by Csl Behring on November 22, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0053-0170-17?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 0053-0170-17?

    The 11-digit format is 00053017017. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20053-0170-175-4-200053-0170-17