Protec Roll-on
NDC Package 68678-067-04

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.

Protec Roll-on is adults and children 2 years of age and older: Roll directly onto affected area without the need to rub, massage or bandage. Marketed by Ach Ventures Corp, this product is identified by NDC 68678-067 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
68678-067-04
Package Description
95 mL in 1 BOTTLE, DISPENSING
Product Code
68678-067
11-Digit Billing Format
68678006704
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Protec Roll-on
Dosage Form
-
Usage Information
Adults and children 2 years of age and older: Roll directly onto affected area without the need to rub, massage or bandage. Repeat as necessary but do not apply more the 4 times dailyChildren under 2 years of age: Consult a Physician

Regulatory & Marketing

Labeler Name
Ach Ventures Corp
FDA Application #
part348
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
02-19-2016
Listing Expiration
12-31-2017
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 68678-067-04 identifies a specific commercial package of 95 ml in 1 bottle, dispensing of Protec Roll-on, labeled by Ach Ventures 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 Ach Ventures Corp on February 19, 2016. The current certification is valid through December 31, 2017.

How is this Ach Ventures Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68678006704. 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)
68678-067-04
11-Digit CMS (5-4-2)
68678-0067-04

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