Revcovi
NDC Package 57665-002-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Revcovi is elapegademase-lvlr is used to treat a certain inherited immune system disorder, adenosine deaminase severe combined immune deficiency (ADA-SCID). Marketed by Leadiant Biosciences, Inc., this product is identified by NDC 57665-002 and is authorized under FDA application BLA761092.

Identification & Billing

NDC Package Code
57665-002-01
Package Description
1 VIAL in 1 CARTON / 1.5 mL in 1 VIAL
Product Code
57665-002
11-Digit Billing Format
57665000201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Revcovi
Dosage Form
-
Usage Information
Elapegademase-lvlr is used to treat a certain inherited immune system disorder, adenosine deaminase severe combined immune deficiency (ADA-SCID). In this condition, the immune system does not work normally to fight infections. People with this disorder tend to get repeated infections that can be very serious or life-threatening. Elapegademase-lvlr is a man-made form of a substance made in your body (adenosine deaminase). It helps increase the number of blood cells that prevent and fight infection (lymphocytes).

Regulatory & Marketing

Labeler Name
Leadiant Biosciences, Inc.
FDA Application #
BLA761092
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-05-2018
End Marketing Date
08-31-2022
Listing Expiration
08-31-2022
Exclude Flag
D
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 57665-002-01 identifies a specific commercial package of 1 vial in 1 carton / 1.5 ml in 1 vial of Revcovi, labeled by Leadiant Biosciences, Inc.. 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 Leadiant Biosciences, Inc. on October 05, 2018. The current certification is valid through August 31, 2022.

What are the primary indications for this medication?

Elapegademase-lvlr is used to treat a certain inherited immune system disorder, adenosine deaminase severe combined immune deficiency (ADA-SCID). In this condition, the immune system does not work normally to fight infections. People with this disorder tend to get repeated infections that can be very serious or life-threatening. Elapegademase-lvlr is a man-made form of a substance made in your body (adenosine deaminase). It helps increase the number of blood cells that prevent and fight infection (lymphocytes).

How is this Leadiant Biosciences, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57665000201. 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)
57665-002-01
11-Digit CMS (5-4-2)
57665-0002-01

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