Sprinjene
NDC Package 63404-0229-1

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.

Sprinjene is supervise children as necessary until capable of using without supervision.Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day as directed by a dentist or physician. Marketed by Health And Natural Beauty Usa Corp, this product is identified by NDC 63404-0229 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
63404-0229-1
Package Description
1 TUBE in 1 CARTON / 100 g in 1 TUBE
Product Code
63404-0229
11-Digit Billing Format
63404022901
RxNorm Crosswalk
  • RxCUI: 891775 - sodium fluoride 0.243 % Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.00243 MG/MG Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste

Clinical Specifications

Proprietary Name
Sprinjene Natural Bubble Gum
Dosage Form
-
Usage Information
Supervise children as necessary until capable of using without supervision.Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day as directed by a dentist or physician. Children 2 to 6 years instruct in good brushing and rinsing habits (to minimize swallowing). Children under 2 years do not use unless directed by a dentist or physician.

Regulatory & Marketing

Labeler Name
Health And Natural Beauty Usa Corp
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2024
Listing Expiration
12-31-2025
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 63404-0229-1 identifies a specific commercial package of 1 tube in 1 carton / 100 g in 1 tube of Sprinjene Natural Bubble Gum, labeled by Health And Natural Beauty Usa Corp. 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 Health And Natural Beauty Usa Corp on April 01, 2024. The current certification is valid through December 31, 2025.

How is this Health And Natural Beauty Usa Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63404022901. 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 (5-4-1)
63404-0229-1
11-Digit CMS (5-4-2)
63404-0229-01

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