Ebanga Injection, Powder, Lyophilized, For Solution
NDC Package 71655-578-08

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

Ebanga (ansuvimab) injection is eBANGA is indicated for the treatment of infection caused by Orthoebolavirus zairense(formerly Zaire ebolavirus) in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2) and Clinical Studies (14)]. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Emergent Manufacturing Operations Baltimore, Llc, this product is identified by NDC 71655-578 and is authorized under FDA application BLA761172.

Identification & Billing

NDC Package Code
71655-578-08
Package Description
8 CARTON in 1 BOX / 36 VIAL, GLASS in 1 CARTON (71655-578-02) / 8 mL in 1 VIAL, GLASS (71655-578-01)
Product Code
71655-578
11-Digit Billing Format
71655057808
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ebanga
Non-Proprietary Name
Ansuvimab
Substance Name
Ansuvimab
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ANSUVIMAB 400 mg/8mL
Pharmacologic Class
Usage Information
EBANGA is indicated for the treatment of infection caused by Orthoebolavirus zairense(formerly Zaire ebolavirus) in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2) and Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Emergent Manufacturing Operations Baltimore, Llc
Product Type
Human Prescription Drug
FDA Application #
BLA761172
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-21-2020
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71655-578). Click a package code to view its specific billing and regulatory data.

71655-578-03
1 CARTON in 1 BOX / 36 VIAL, GLASS in 1 CARTON (71655-578-02) / 8 mL in 1 VIAL, GLASS (71655-578-01)
71655-578-04
4 CARTON in 1 BOX / 36 VIAL, GLASS in 1 CARTON (71655-578-02) / 8 mL in 1 VIAL, GLASS (71655-578-01)

* 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 71655-578-08 identifies a specific commercial package of 8 carton in 1 box / 36 vial, glass in 1 carton (71655-578-02) / 8 ml in 1 vial, glass (71655-578-01) of Ebanga, a human prescription drug labeled by Emergent Manufacturing Operations Baltimore, Llc. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains ansuvimab 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 Emergent Manufacturing Operations Baltimore, Llc on December 21, 2020. The current certification is valid through December 31, 2027.

How is this Emergent Manufacturing Operations Baltimore, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71655057808. 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)
71655-578-08
11-Digit CMS (5-4-2)
71655-0578-08

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