NDC Package 57665-002-01 Revcovi

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

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

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:

57665-002-01

Package Description:

1 VIAL in 1 CARTON / 1.5 mL in 1 VIAL

Product Code:

57665-002

Proprietary Name:

Revcovi

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).

11-Digit NDC Billing Format:

57665000201

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

RxCUI: 213040 - ONCASPAR 3750 UNT in 5 ML Injection
RxCUI: 213040 - 5 ML pegaspargase 750 UNT/ML Injection [Oncaspar]
RxCUI: 213040 - Oncaspar 3750 UNT per 5 ML Injection
RxCUI: 240906 - pegaspargase 3750 UNT in 5 ML Injection
RxCUI: 240906 - 5 ML pegaspargase 750 UNT/ML Injection

Labeler Name:

Leadiant Biosciences, Inc.

Sample Package:

FDA Application Number:

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 Date:

08-31-2022

Exclude Flag:

Code Structure:

57665 - Leadiant Biosciences, Inc.
- 57665-002 - Revcovi
  - 57665-002-01 - 1 VIAL in 1 CARTON / 1.5 mL in 1 VIAL

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.

Frequently Asked Questions

What is NDC 57665-002-01?

The NDC Packaged Code 57665-002-01 is assigned to a package of 1 vial in 1 carton / 1.5 ml in 1 vial of Revcovi, labeled by Leadiant Biosciences, Inc.. The product's dosage form is and is administered via form.

Is NDC 57665-002 included in the NDC Directory?

No, Revcovi with product code 57665-002 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Leadiant Biosciences, Inc. on October 05, 2018 and its listing in the NDC Directory is set to expire on August 31, 2022 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 57665-002-01?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 57665-002-01?

The 11-digit format is 57665000201. 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	57665-002-01	5-4-2	57665-0002-01

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