Dr.jucre Rebirth Activating Toner Liquid
NDC Package 83071-020-02

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

Package Information

Dr.jucre Rebirth Activating Toner (betaine) liquids 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 liquid delivery system. Marketed by Naturecell Co., Ltd., this product is identified by NDC 83071-020.

Identification & Billing

NDC Package Code
83071-020-02
Package Description
1 BOTTLE in 1 CARTON / 150 mL in 1 BOTTLE (83071-020-01)
Product Code
83071-020
11-Digit Billing Format
83071002002

Clinical Specifications

Proprietary Name
Dr.jucre Rebirth Activating Toner
Non-Proprietary Name
Betaine
Substance Name
Betaine
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
BETAINE .001 g/100mL
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
Naturecell Co., Ltd.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
10-01-2022
Listing Expiration
12-31-2026
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 83071-020-02 identifies a specific commercial package of 1 bottle in 1 carton / 150 ml in 1 bottle (83071-020-01) of Dr.jucre Rebirth Activating Toner, a human over the counter drug labeled by Naturecell Co., Ltd.. This liquid is formulated for topical 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 Naturecell Co., Ltd. on October 01, 2022. The current certification is valid through December 31, 2026.

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 Naturecell Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83071002002. 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)
83071-020-02
11-Digit CMS (5-4-2)
83071-0020-02

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