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  5. NDC Package Code: 71981-001-01 Oxervate

NDC Package 71981-001-01 Oxervate

Cenegermin-bkbj Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Oxervate
Non-Proprietary Name:
Cenegermin-bkbj
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.
11-Digit NDC Billing Format:
71981000101
NDC to RxNorm Crosswalk:
  • RxCUI: 2104336 - cenegermin-bkbj 0.002 % Ophthamic Solution
  • RxCUI: 2104336 - cenegermin-bkbj 0.02 MG/ML Ophthalmic Solution
  • RxCUI: 2104336 - cenegermin-bkbj 20 MCG/ML Ophthamic Solution
  • RxCUI: 2104341 - oxervate 0.002 % Ophthamic Solution
  • RxCUI: 2104341 - cenegermin-bkbj 0.02 MG/ML Ophthalmic Solution [Oxervate]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Domp� Farmaceutici S.p.a.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    BLA761094
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    11-26-2018
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 71981-001-01?

    The NDC Packaged Code 71981-001-01 is assigned to a 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.. The product's dosage form is kit and is administered via form.

    Is NDC 71981-001 included in the NDC Directory?

    Yes, Oxervate with product code 71981-001 is active and included in the NDC Directory. The product was first marketed by Domp� Farmaceutici S.p.a. on November 26, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 71981-001-01?

    The 11-digit format is 71981000101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-271981-001-015-4-271981-0001-01