Ebanga
NDC Package 80673-777-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Ebanga is indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection [see Dosage and Administration (2.2) and Clinical Studies (14)]. Marketed by Ridgeback Biotherapeutics, Lp, this product is identified by NDC 80673-777 and is authorized under FDA application BLA761172.

Identification & Billing

NDC Package Code
80673-777-01
Package Description
1 CARTON in 1 BOX / 1 KIT in 1 CARTON * 36 VIAL, SINGLE-DOSE in 1 CARTON (80673-001-36) / 8 mL in 1 VIAL, SINGLE-DOSE (80673-001-01)
Product Code
80673-777
11-Digit Billing Format
80673077701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ebanga
Dosage Form
-
Usage Information
EBANGA is indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection [see Dosage and Administration (2.2) and Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Ridgeback Biotherapeutics, Lp
FDA Application #
BLA761172
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-21-2020
Listing Expiration
12-31-2026
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (80673-777). Click a package code to view its specific billing and regulatory data.

80673-777-04
4 CARTON in 1 BOX / 1 KIT in 1 CARTON * 36 VIAL, SINGLE-DOSE in 1 CARTON (80673-001-36) / 8 mL in 1 VIAL, SINGLE-DOSE (80673-001-01)
80673-777-08
8 CARTON in 1 BOX / 1 KIT in 1 CARTON * 36 VIAL, SINGLE-DOSE in 1 CARTON (80673-001-36) / 8 mL in 1 VIAL, SINGLE-DOSE (80673-001-01)

* 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 80673-777-01 identifies a specific commercial package of 1 carton in 1 box / 1 kit in 1 carton * 36 vial, single-dose in 1 carton (80673-001-36) / 8 ml in 1 vial, single-dose (80673-001-01) of Ebanga, labeled by Ridgeback Biotherapeutics, Lp. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Ridgeback Biotherapeutics, Lp on December 21, 2020. The current certification is valid through December 31, 2026.

How is this Ridgeback Biotherapeutics, Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80673077701. 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)
80673-777-01
11-Digit CMS (5-4-2)
80673-0777-01

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