Cystadane Powder, For Solution
NDC Package 52276-400-01

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

Package Information

Cystadane (betaine) powders is a medication used to treat high levels of a certain important body chemical (homocysteine) due to an inherited disorder (homocystinuria). This formulation utilizes a powder, for solution delivery system. Marketed by Recordati Rare Diseases, this product is identified by NDC 52276-400 and is authorized under FDA application NDA020576.

Identification & Billing

NDC Package Code
52276-400-01
Package Description
180 g in 1 BOTTLE
Product Code
52276-400
11-Digit Billing Format
52276040001
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
180 GM
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Cystadane
Non-Proprietary Name
Betaine
Substance Name
Betaine
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BETAINE 1 g/g
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Recordati Rare Diseases
Product Type
Human Prescription Drug
FDA Application #
NDA020576
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-25-1996
Listing Expiration
12-31-2027
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 52276-400-01 identifies a specific commercial package of 180 g in 1 bottle of Cystadane, a human prescription drug labeled by Recordati Rare Diseases. This product is billed per "GM" gram and contains an estimated amount of 180 billable units per package. This powder, for solution is formulated for oral use and contains betaine 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 Recordati Rare Diseases on October 25, 1996. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Recordati Rare Diseases product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52276040001. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 180 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)
52276-400-01
11-Digit CMS (5-4-2)
52276-0400-01

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