Cystadane
NDC 52276-401
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Cystadane is a UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE-approved product labeled by Orphan Europe Sarl. This medication is used to treat high levels of a certain important body chemical (homocysteine) due to an inherited disorder (homocystinuria). It is supplied as a white product. This product entry covers the primary NDC 52276-401 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
52276-401
Proprietary Name:
Cystadane
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
52276
Product Label ID:
Marketing Category: [8]
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing Timeline
Start Marketing Date: [9]
01-08-2018
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Product Characteristics
Color(s):
WHITE (C48325)
Code Structure Chart
Product Details
What is NDC 52276-401?
The NDC code 52276-401 is assigned by the FDA to the product Cystadane. This pharmaceutical product is labeled by Orphan Europe Sarl and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 52276-401-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
This medication is used to treat high levels of a certain important body chemical (homocysteine) due to an inherited disorder (homocystinuria). Decreasing high homocysteine levels may help prevent serious blood clots, abnormal bone formation, brittle bones (osteoporosis), and eye problems (e.g., dislocated eye lens, nearsightedness). This medication works by decreasing blood levels of homocysteine. It does not correct the inherited disorder that causes the disease.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- BETAINE (UNII: 3SCV180C9W)
- BETAINE (UNII: 3SCV180C9W) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
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: 404539 - Cystadane 1 GM/Scoop Powder for Oral Solution
- RxCUI: 404539 - betaine 1000 MG Powder for Oral Solution [Cystadane]
- RxCUI: 404539 - Cystadane 1000 MG (as betaine anhydrous) Powder for Oral Solution
- RxCUI: 404539 - Cystadane 1000 MG Powder for Oral Solution
- RxCUI: 562847 - betaine anhydrous 1 GM/Scoop Powder for Oral Solution
* Please review the full disclaimer at the bottom of this page.
Patient Education
Betaine
Betaine is used to treat homocystinuria (an inherited condition in which the body cannot break down a certain protein, causing build-up of homocysteine in the blood). Increased amounts of homocysteine in the body can cause symptoms such as extreme tiredness, seizures, dislocation of the lens of the eye, abnormal bone structure, osteoporosis (weak bones), blood clots, or decreased weight or rate of weight gain and slowed development in children. Betaine is in a class of medications called nutrients. It works by decreasing the amount of homocysteine in the blood.
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* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
