Oxervate Kit
NDC Package 71981-001-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Oxervate (cenegermin-bkbj) kits is a medication 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). This formulation utilizes a kit delivery system. Marketed by Domp� Farmaceutici S.p.a., this product is identified by NDC 71981-001 and is authorized under FDA application BLA761094.

Identification & Billing

NDC Package Code
71981-001-01
Package Description
1 KIT in 1 KIT * 7 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE
Product Code
71981-001
11-Digit Billing Format
71981000101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxervate
Non-Proprietary Name
Cenegermin-bkbj
Dosage Form
Kit - A packaged collection of related material.
Usage Information
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.

Regulatory & Marketing

Labeler Name
Domp� Farmaceutici S.p.a.
Product Type
Human Prescription Drug
FDA Application #
BLA761094
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-26-2018
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71981-001-01 identifies a specific commercial package of 1 kit in 1 kit * 7 vial, multi-dose in 1 carton / 1 ml in 1 vial, multi-dose of Oxervate, a human prescription drug labeled by Domp� Farmaceutici S.p.a.. 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 Domp� Farmaceutici S.p.a. on November 26, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Domp� Farmaceutici S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71981000101. 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)
71981-001-01
11-Digit CMS (5-4-2)
71981-0001-01

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