1. Home
  2. Labeler Index
  3. Domp� Farmaceutici S.p.a.
  4. NDC Product Code: 71981-001 Oxervate

NDC 71981-001 Oxervate

Cenegermin-bkbj Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 71981-001?
  4. Oxervate Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

NDC Product Code:
71981-001
Proprietary Name:
Oxervate
Non-Proprietary Name: [1]
Cenegermin-bkbj
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]
Domp� Farmaceutici S.p.a.
Labeler Code:
71981
Product Label ID:
89e4bfec-d710-40ed-8885-5d13ba46b1cd
FDA Application Number: [6]
BLA761094
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
11-26-2018
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Navigator:

Code Structure Chart

Product Details

What is NDC 71981-001?

The NDC code 71981-001 is assigned by the FDA to the product Oxervate which is a human prescription drug product labeled by Domp� Farmaceutici S.p.a.. The generic name of Oxervate is cenegermin-bkbj. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 71981-001-01 1 kit in 1 kit * 7 vial, multi-dose in 1 carton / 1 ml in 1 vial, multi-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 Oxervate?

This medication is used to treat a certain eye disorder (neurotrophic keratitis) that causes a loss of nerve function to a certain part of your eye (the cornea). Cenegermin-bkbj is a man-made form of a substance made by your body. It is used by your body to help maintain and make more nerve cells in your eyes. This medication may help prevent decreased vision or loss of vision caused by neurotrophic keratitis.

Which are Oxervate UNII Codes?

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

Which are Oxervate 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 Oxervate?

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:

* Please review the disclaimer below.

Patient Education

Cenegermin-bkbj Ophthalmic


Ophthalmic cenegermin-bkbj is used to treat neurotrophic keratitis (a degenerative eye disease that can lead to damage of the cornea [the outermost layer of the eye]). Cenegermin-bkbj is in a class of medications called recombinant human nerve growth factors. It works to heal the cornea.
[Learn More]


* 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 ("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".