Luxturna Kit
NDC Package 71394-415-01

11-digit billing NDC: 71394041501 · Billing unit: ML
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Luxturna (voretigene neparvovec-rzyl) kits is lUXTURNA (voretigene neparvovec-rzyl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.Patients must have viable retinal cells as determined by the treating physician(s). This formulation utilizes a kit delivery system. Marketed by Spark Therapeutics, Inc., this product is identified by NDC 71394-415 and is authorized under FDA application BLA125610.

Identification & Billing

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
11-Digit Billing Format
71394041501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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]

Clinical Specifications

Proprietary Name
Luxturna
Non-Proprietary Name
Voretigene Neparvovec-rzyl
Dosage Form
Kit - A packaged collection of related material.
Usage Information
LUXTURNA (voretigene neparvovec-rzyl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.Patients must have viable retinal cells as determined by the treating physician(s).

Regulatory & Marketing

Labeler Name
Spark Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125610
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-19-2017
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J3398
Source: OPPS
Inj luxturna 1 billion vec g
HCPCS Dosage 1 billion vector genomes
Units / Pkg 150

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71394-415-01 identifies a specific commercial 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.. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Spark Therapeutics, Inc. on December 19, 2017. The current certification is valid through December 31, 2027.

How is this Spark Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71394041501. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
71394-415-01
11-Digit CMS (5-4-2)
71394-0415-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.