Betaine Powder, For Solution
NDC Package 0713-0352-81

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

Package Information

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 Cosette Pharmaceuticals, Inc., this product is identified by NDC 0713-0352 and is authorized under FDA application ANDA214864.

Identification & Billing

NDC Package Code
0713-0352-81
Package Description
180 g in 1 BOTTLE
Product Code
0713-0352
11-Digit Billing Format
00713035281
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
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
Cosette Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA214864
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2023
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 0713-0352-81 identifies a specific commercial package of 180 g in 1 bottle of Betaine, a human prescription drug labeled by Cosette Pharmaceuticals, Inc.. 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 Cosette Pharmaceuticals, Inc. on January 01, 2023. 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 Cosette Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00713035281. 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 (4-4-2)
0713-0352-81
11-Digit CMS (5-4-2)
00713-0352-81

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