NDC 75987-100 Procysbi

Cysteamine Bitartrate Capsule, Delayed Release Pellets Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
75987-100
Proprietary Name:
Procysbi
Non-Proprietary Name: [1]
Cysteamine Bitartrate
Substance Name: [2]
Cysteamine Bitartrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Horizon Therapeutics Usa, Inc.
    Labeler Code:
    75987
    FDA Application Number: [6]
    NDA203389
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    04-30-2013
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333)
    Shape:
    CAPSULE (C48336)
    Size(s):
    16 MM
    Imprint(s):
    PRO;25;MG
    Score:
    1

    Product Packages

    NDC Code 75987-100-04

    Package Description: 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE

    Product Details

    What is NDC 75987-100?

    The NDC code 75987-100 is assigned by the FDA to the product Procysbi which is a human prescription drug product labeled by Horizon Therapeutics Usa, Inc.. The generic name of Procysbi is cysteamine bitartrate. The product's dosage form is capsule, delayed release pellets and is administered via oral form. The product is distributed in a single package with assigned NDC code 75987-100-04 60 capsule, delayed release pellets in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Procysbi?

    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.

    What are Procysbi Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • CYSTEAMINE BITARTRATE 25 mg/1 - A mercaptoethylamine compound that is endogenously derived from the COENZYME A degradative pathway. The fact that cysteamine is readily transported into LYSOSOMES where it reacts with CYSTINE to form cysteine-cysteamine disulfide and CYSTEINE has led to its use in CYSTINE DEPLETING AGENTS for the treatment of CYSTINOSIS.

    Which are Procysbi UNII Codes?

    The UNII codes for the active ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Procysbi?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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

    Which are the Pharmacologic Classes for Procysbi?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".