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  5. NDC Package Code: 52276-400-01 Cystadane

NDC Package 52276-400-01 Cystadane

Betaine Powder, For Solution 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:
52276-400-01
Package Description:
180 g in 1 BOTTLE
Product Code:
52276-400
Proprietary Name:
Cystadane
Non-Proprietary Name:
Betaine
Substance Name:
Betaine
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.
11-Digit NDC Billing Format:
52276040001
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
180 GM
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Recordati Rare Diseases
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • BETAINE 1 g/g
    • Pharmacologic Class(es):
  • Methylating Activity - [MoA] (Mechanism of Action)
  • Methylating Agent - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA020576
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-25-1996
    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 52276-400-01?

    The NDC Packaged Code 52276-400-01 is assigned to a package of 180 g in 1 bottle of Cystadane, a human prescription drug labeled by Recordati Rare Diseases. The product's dosage form is powder, for solution and is administered via oral form.This product is billed per "GM" gram and contains an estimated amount of 180 billable units per package.

    Is NDC 52276-400 included in the NDC Directory?

    Yes, Cystadane with product code 52276-400 is active and included in the NDC Directory. The product was first marketed by Recordati Rare Diseases on October 25, 1996 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 52276-400-01?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 180.

    What is the 11-digit format for NDC 52276-400-01?

    The 11-digit format is 52276040001. 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
    5-3-252276-400-015-4-252276-0400-01