Roota Re V For Women
NDC Package 54576-2001-1

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.

Roota Re V For Women is 1. Marketed by Raphabio Inc, this product is identified by NDC 54576-2001.

Identification & Billing

NDC Package Code
54576-2001-1
Package Description
240 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
54576-2001
11-Digit Billing Format
54576200101

Clinical Specifications

Proprietary Name
Roota Re V For Women
Dosage Form
-
Usage Information
1. apply sufficient quantity to intended part2. scrub softly as like doing massage

Regulatory & Marketing

Labeler Name
Raphabio Inc
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
12-31-2012
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 54576-2001-1 identifies a specific commercial package of 240 ml in 1 bottle, with applicator of Roota Re V For Women, labeled by Raphabio Inc. 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 Raphabio Inc on December 31, 2012. The current certification is valid through December 31, 2017.

How is this Raphabio Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54576200101. 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)
54576-2001-1
11-Digit CMS (5-4-2)
54576-2001-01

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