NDC Package 71655-578-03 Ebanga

Ansuvimab Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Package Information
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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:

71655-578-03

Package Description:

1 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

Proprietary Name:

Ebanga

Non-Proprietary Name:

Ansuvimab

Substance Name:

Ansuvimab

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)].

11-Digit NDC Billing Format:

71655057803

NDC to RxNorm Crosswalk:

RxCUI: 2472156 - ansuvimab-zykl 400 MG Injection
RxCUI: 2472161 - ebanga 400 MG Injection
RxCUI: 2472161 - ansuvimab-zykl 400 MG Injection [Ebanga]
RxCUI: 2472161 - Ebanga 400 MG Injection

Product Type:

Human Prescription Drug

Labeler Name:

Emergent Manufacturing Operations Baltimore, Llc

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(s):

Intravenous - Administration within or into a vein or veins.

Active Ingredient(s):

ANSUVIMAB 400 mg/8mL

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

BLA761172

Marketing Category:

BLA - A product marketed under an approved Biologic License Application.

Start Marketing Date:

12-21-2020

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

71655 - Emergent Manufacturing Operations Baltimore, Llc
- 71655-578 - Ebanga
  - 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)

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
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)
71655-578-08	8 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 disclaimer below.

Frequently Asked Questions

What is NDC 71655-578-03?

The NDC Packaged Code 71655-578-03 is assigned to a package of 1 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. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

Is NDC 71655-578 included in the NDC Directory?

Yes, Ebanga with product code 71655-578 is active and included in the NDC Directory. The product was first marketed by Emergent Manufacturing Operations Baltimore, Llc on December 21, 2020 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 71655-578-03?

The 11-digit format is 71655057803. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	71655-578-03	5-4-2	71655-0578-03

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