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  4. NDC Product Code: 71469-231 Gleolan

NDC 71469-231 Gleolan

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 71469-231?
  5. Gleolan Uses
  6. Active Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
71469-231
Proprietary Name:
Gleolan
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Nx Development Corp
Labeler Code:
71469
Product Label ID:
cdeded66-0017-42cf-9471-13f231014323
Start Marketing Date: [9]
03-14-2018
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - CLEAR TO SLIGHTLY YELLOWISH)

Code Structure Chart

Product Details

What is NDC 71469-231?

The NDC code 71469-231 is assigned by the FDA to the product Gleolan which is product labeled by Nx Development Corp. The product's dosage form is . The product is distributed in a single package with assigned NDC code 71469-231-01 1 vial, single-dose in 1 carton / 1 powder, for solution in 1 vial, single-dose. 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 Gleolan?

Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery.

Which are Gleolan UNII Codes?

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

  • AMINOLEVULINIC ACID HYDROCHLORIDE (UNII: V35KBM8JGR)
  • AMINOLEVULINIC ACID (UNII: 88755TAZ87) (Active Moiety)

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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".