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  4. NDC Product Code: 71394-415 Luxturna

NDC 71394-415 Luxturna

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
71394-415
Proprietary Name:
Luxturna
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Spark Therapeutics, Inc.
Labeler Code:
71394
Product Label ID:
08313a24-e7ce-457a-bb3f-161bc45517ee
Start Marketing Date: [9]
12-19-2017
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
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Product Details

What is NDC 71394-415?

The NDC code 71394-415 is assigned by the FDA to the product Luxturna which is product labeled by Spark Therapeutics, Inc.. The product's dosage form is . 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

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[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".