Revcovi Injection
NDC Package 10122-502-01

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

Package Information

Revcovi (elapegademase-lvlr) injection is elapegademase-lvlr is used to treat a certain inherited immune system disorder, adenosine deaminase severe combined immune deficiency (ADA-SCID). This formulation utilizes a injection delivery system. Marketed by Chiesi Usa, Inc., this product is identified by NDC 10122-502 and is authorized under FDA application BLA761092.

Identification & Billing

NDC Package Code
10122-502-01
Package Description
1 VIAL in 1 CARTON / 1.5 mL in 1 VIAL
Product Code
10122-502
11-Digit Billing Format
10122050201
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
Non-Proprietary Name
Elapegademase-lvlr
Substance Name
Elapegademase
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
ELAPEGADEMASE 1.6 mg/mL
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
Chiesi Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761092
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-05-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10122-502-01 identifies a specific commercial package of 1 vial in 1 carton / 1.5 ml in 1 vial of Revcovi, a human prescription drug labeled by Chiesi Usa, Inc.. This injection is formulated for intramuscular use and contains elapegademase 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 Chiesi Usa, Inc. on October 05, 2018. The current certification is valid through December 31, 2027.

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 Chiesi Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10122050201. 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)
10122-502-01
11-Digit CMS (5-4-2)
10122-0502-01

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