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  5. NDC Package Code: 75987-100-04 Procysbi

NDC Package 75987-100-04 Procysbi

Cysteamine Bitartrate Capsule, Delayed Release Pellets Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
75987-100-04
Package Description:
60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
Product Code:
75987-100
Proprietary Name:
Procysbi
Non-Proprietary Name:
Cysteamine Bitartrate
Substance Name:
Cysteamine Bitartrate
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.
11-Digit NDC Billing Format:
75987010004
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Horizon Therapeutics Usa, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CYSTEAMINE BITARTRATE 25 mg/1
    • Pharmacologic Class(es):
  • Cystine Depleting Agent - [EPC] (Established Pharmacologic Class)
  • Cystine Disulfide Reduction - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA203389
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-30-2013
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 75987-100-04?

    The NDC Packaged Code 75987-100-04 is assigned to a package of 60 capsule, delayed release pellets in 1 bottle of Procysbi, a human prescription drug labeled by Horizon Therapeutics Usa, Inc.. The product's dosage form is capsule, delayed release pellets and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package.

    Is NDC 75987-100 included in the NDC Directory?

    Yes, Procysbi with product code 75987-100 is active and included in the NDC Directory. The product was first marketed by Horizon Therapeutics Usa, Inc. on April 30, 2013 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 75987-100-04?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

    What is the 11-digit format for NDC 75987-100-04?

    The 11-digit format is 75987010004. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-275987-100-045-4-275987-0100-04