Procysbi
NDC Package 49663-002-25

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.

Procysbi is a medication used to help preserve kidney function and manage kidney damage and other problems in people with an inherited disorder that causes build-up of a certain natural substance (cystine) in the body (nephropathic cystinosis). Marketed by Raptor Therapeutics Inc., this product is identified by NDC 49663-002 and is authorized under FDA application NDA203389.

Identification & Billing

NDC Package Code
49663-002-25
Package Description
250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC
Product Code
49663-002
11-Digit Billing Format
49663000225
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
250 EA

Clinical Specifications

Proprietary Name
Procysbi Delayed-release
Dosage Form
-
Usage Information
This medication is used to help preserve kidney function and manage kidney damage and other problems in people with an inherited disorder that causes build-up of a certain natural substance (cystine) in the body (nephropathic cystinosis). Cystine build-up can cause problems such as kidney problems, slow growth, weak bones, and eye problems. Cysteamine helps the body get rid of cystine.

Regulatory & Marketing

Labeler Name
Raptor Therapeutics Inc.
FDA Application #
NDA203389
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-30-2013
End Marketing Date
02-28-2019
Listing Expiration
02-28-2019
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 49663-002-25 identifies a specific commercial package of 250 capsule, delayed release pellets in 1 bottle, plastic of Procysbi Delayed-release, labeled by Raptor Therapeutics Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 250 billable units per package. 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 Raptor Therapeutics Inc. on April 30, 2013. The current certification is valid through February 28, 2019.

What are the primary indications for this medication?

This medication is used to help preserve kidney function and manage kidney damage and other problems in people with an inherited disorder that causes build-up of a certain natural substance (cystine) in the body (nephropathic cystinosis). Cystine build-up can cause problems such as kidney problems, slow growth, weak bones, and eye problems. Cysteamine helps the body get rid of cystine.

How is this Raptor Therapeutics Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49663000225. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 250 total billable units per package. 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)
49663-002-25
11-Digit CMS (5-4-2)
49663-0002-25

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