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  4. NDC Product Code: 71394-415 Luxturna

NDC 71394-415 Luxturna

Voretigene Neparvovec-rzyl Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 71394-415?
  4. Luxturna Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

Get all the details for National Drug Code (NDC) 71394-415 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
71394-415
Proprietary Name:
Luxturna
Non-Proprietary Name: [1]
Voretigene Neparvovec-rzyl
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]
Spark Therapeutics, Inc.
Labeler Code:
71394
Product Label ID:
08313a24-e7ce-457a-bb3f-161bc45517ee
HCPCS Code:
J3398 - Inj luxturna 1 billion vec g
FDA Application Number: [6]
BLA125610
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
12-19-2017
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Navigator:

Code Structure Chart

Product Details

What is NDC 71394-415?

The NDC code 71394-415 is assigned by the FDA to the product Luxturna which is a human prescription drug product labeled by Spark Therapeutics, Inc.. The generic name of Luxturna is voretigene neparvovec-rzyl. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 71394-415-01 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). 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 Luxturna?

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.

Which are Luxturna UNII Codes?

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

Which are Luxturna Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Luxturna?

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: 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]

* 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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".