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  5. NDC Package Code: 71394-415-01 Luxturna

NDC Package 71394-415-01 Luxturna

Voretigene Neparvovec-rzyl Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

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:
71394-415-01
Package Description:
1 KIT in 1 CARTON * 1 INJECTION, SUSPENSION in 1 VIAL, PLASTIC (71394-065-01) * 1 INJECTION, SOLUTION in 1 VIAL, PLASTIC (71394-716-01)
Product Code:
71394-415
Proprietary Name:
Luxturna
Non-Proprietary Name:
Voretigene Neparvovec-rzyl
Usage Information:
This medication is used to treat a certain inherited eye condition (retinal dystrophy). Voretigene neparvovec-rzyl is made from a certain virus that has been specially prepared. The virus is used to carry a certain human gene (RPE65) into cells. You will receive this treatment only after tests by your doctor have found that this gene does not work the way it should in your cells. This type of treatment is known as gene therapy. Treatment may improve symptoms of retinal dystrophy, such as decreased vision, loss of side vision, or poor vision at night.
11-Digit NDC Billing Format:
71394041501
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1995884 - voretigene neparvovec-rzyl 5,000,000,000,000 VECTOR-GENOMES/ML in 0.5 ML Injection
  • RxCUI: 1995884 - 0.5 ML voretigene neparvovec-rzyl 5000000000000 VECTOR-GENOMES/ML Injection
  • RxCUI: 1995884 - voretigene neparvovec-rzyl 5,000,000,000,000 VECTOR-GENOMES/ML per 0.5 ML Injection
  • RxCUI: 1995886 - Luxturna 5,000,000,000,000 VECTOR-GENOMES/ML in 0.5 ML Injection
  • RxCUI: 1995886 - 0.5 ML voretigene neparvovec-rzyl 5000000000000 VECTOR-GENOMES/ML Injection [Luxturna]
Product Type:
Human Prescription Drug
Labeler Name:
Spark Therapeutics, Inc.
Dosage Form:
Kit - A packaged collection of related material.
Sample Package:
No
FDA Application Number:
BLA125610
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
12-19-2017
Listing Expiration Date:
12-31-2025
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 71394-415-01 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
71394041501J3398Inj luxturna 1 billion vec g1 billion vector genomes0.51150150

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 71394-415-01?

The NDC Packaged Code 71394-415-01 is assigned to a package of 1 kit in 1 carton * 1 injection, suspension in 1 vial, plastic (71394-065-01) * 1 injection, solution in 1 vial, plastic (71394-716-01) of Luxturna, a human prescription drug labeled by Spark Therapeutics, Inc.. The product's dosage form is kit and is administered via form.

Is NDC 71394-415 included in the NDC Directory?

Yes, Luxturna with product code 71394-415 is active and included in the NDC Directory. The product was first marketed by Spark Therapeutics, Inc. on December 19, 2017 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 71394-415-01?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 71394-415-01?

The 11-digit format is 71394041501. 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 5-3-2 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
5-3-271394-415-015-4-271394-0415-01