Betaine Anhydrous For Oral Solution
NDC Package 55792-002-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Betaine Anhydrous For Oral Solution is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. Marketed by Lukare Medical, Llc, this product is identified by NDC 55792-002 and is authorized under FDA application ANDA210508.

Identification & Billing

NDC Package Code
55792-002-01
Package Description
180 g in 1 BOTTLE
Product Code
55792-002
11-Digit Billing Format
55792000201
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
180 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Betaine Anhydrous For Oral Solution
Dosage Form
-
Usage Information
Betaine Anhydrous for Oral Solution is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. Included within the category of homocystinuria are: •Cystathionine beta-synthase (CBS) deficiency•5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency•Cobalamin cofactor metabolism (cbl) defect

Regulatory & Marketing

Labeler Name
Lukare Medical, Llc
FDA Application #
ANDA210508
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-11-2022
Listing Expiration
12-31-2023
Exclude Flag
I
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 55792-002-01 identifies a specific commercial package of 180 g in 1 bottle of Betaine Anhydrous For Oral Solution, labeled by Lukare Medical, Llc. This product is billed per "GM" gram and contains an estimated amount of 180 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Lukare Medical, Llc on February 11, 2022. The current certification is valid through December 31, 2023.

How is this Lukare Medical, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55792000201. 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)
55792-002-01
11-Digit CMS (5-4-2)
55792-0002-01

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