Pristine1
NDC Package 77605-110-01

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

Package Information

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

Pristine1 is put enough product in your palm to cover hands and rub hands together briskly until dry. Marketed by Caribbean Spirit Imports Llc, this product is identified by NDC 77605-110 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
77605-110-01
Package Description
325 mL in 1 BOTTLE, PLASTIC
Product Code
77605-110
11-Digit Billing Format
77605011001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pristine1
Dosage Form
-
Usage Information
Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using.

Regulatory & Marketing

Labeler Name
Caribbean Spirit Imports Llc
FDA Application #
part333A
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
03-30-2020
Listing Expiration
12-31-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (77605-110). Click a package code to view its specific billing and regulatory data.

77605-110-02
3785 mL in 1 BOTTLE, PLASTIC

* 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 77605-110-01 identifies a specific commercial package of 325 ml in 1 bottle, plastic of Pristine1, labeled by Caribbean Spirit Imports Llc. 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 Caribbean Spirit Imports Llc on March 30, 2020. The current certification is valid through December 31, 2021.

How is this Caribbean Spirit Imports Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 77605011001. 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)
77605-110-01
11-Digit CMS (5-4-2)
77605-0110-01

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