Oxervate Solution/ Drops
NDC Package 71981-020-07

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) solution/ dropses 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 solution/ drops delivery system. Marketed by Domp� Farmaceutici S.p.a., this product is identified by NDC 71981-020 and is authorized under FDA application BLA761094.

Identification & Billing

NDC Package Code
71981-020-07
Package Description
7 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE
Product Code
71981-020
11-Digit Billing Format
71981002007
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxervate
Non-Proprietary Name
Cenegermin-bkbj
Substance Name
Cenegermin
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
CENEGERMIN 20 ug/mL
Pharmacologic Class
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 71981-020-07 identifies a specific commercial package of 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 solution/ drops is formulated for ophthalmic use and contains cenegermin 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: 71981002007. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
71981-020-07
11-Digit CMS (5-4-2)
71981-0020-07

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