Symba Skin Lightening
NDC Package 71607-200-01

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.

Symba Skin Lightening is for sensitive skin, test overnight on a small section of skin inside the elbow before useapply a thin layer to skin on affected areasuse sunscreen to prevent darkening from recurringuse twice daily for at least 6 weeks or as directed by doctor. Marketed by Craig Doura Llc, this product is identified by NDC 71607-200 and is authorized under FDA application part358A.

Identification & Billing

NDC Package Code
71607-200-01
Package Description
1 TUBE in 1 CARTON / 57 g in 1 TUBE (71607-200-57)
Product Code
71607-200
11-Digit Billing Format
71607020001

Clinical Specifications

Proprietary Name
Symba Skin Lightening
Dosage Form
-
Usage Information
For sensitive skin, test overnight on a small section of skin inside the elbow before useapply a thin layer to skin on affected areasuse sunscreen to prevent darkening from recurringuse twice daily for at least 6 weeks or as directed by doctor

Regulatory & Marketing

Labeler Name
Craig Doura Llc
FDA Application #
part358A
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
10-12-2017
Listing Expiration
12-31-2018
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 71607-200-01 identifies a specific commercial package of 1 tube in 1 carton / 57 g in 1 tube (71607-200-57) of Symba Skin Lightening, labeled by Craig Doura 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 Craig Doura Llc on October 12, 2017. The current certification is valid through December 31, 2018.

How is this Craig Doura Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71607020001. 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)
71607-200-01
11-Digit CMS (5-4-2)
71607-0200-01

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