Procysbi Capsule, Delayed Release Pellets
NDC Package 75987-101-08

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

Package Information

Procysbi (cysteamine bitartrate) capsules 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). This formulation utilizes a capsule, delayed release pellets delivery system. Marketed by Horizon Therapeutics Usa, Inc., this product is identified by NDC 75987-101 and is authorized under FDA application NDA203389.

Identification & Billing

NDC Package Code
75987-101-08
Package Description
250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
Product Code
75987-101
11-Digit Billing Format
75987010108
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
250 EA
RxNorm Crosswalk
  • RxCUI: 1421467 - cysteamine 25 MG Delayed Release Oral Capsule
  • RxCUI: 1421467 - cysteamine 25 MG (as cysteamine bitartrate 74 mg) Delayed Release Oral Capsule
  • RxCUI: 1421473 - PROCYSBI 25 MG Delayed Release Oral Capsule
  • RxCUI: 1421473 - cysteamine 25 MG Delayed Release Oral Capsule [Procysbi]
  • RxCUI: 1421473 - Procysbi (cysteamine 25 MG (as cysteamine bitartrate 74 MG)) Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Procysbi
Non-Proprietary Name
Cysteamine Bitartrate
Substance Name
Cysteamine Bitartrate
Dosage Form
Capsule, Delayed Release Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CYSTEAMINE BITARTRATE 75 mg/1
Pharmacologic Class
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
Horizon Therapeutics Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA203389
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-30-2013
Listing Expiration
12-31-2026
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 75987-101-08 identifies a specific commercial package of 250 capsule, delayed release pellets in 1 bottle of Procysbi, a human prescription drug labeled by Horizon Therapeutics Usa, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 250 billable units per package. This capsule, delayed release pellets is formulated for oral use and contains cysteamine bitartrate 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 Horizon Therapeutics Usa, Inc. on April 30, 2013. The current certification is valid through December 31, 2026.

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 Horizon Therapeutics Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75987010108. 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)
75987-101-08
11-Digit CMS (5-4-2)
75987-0101-08

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