Tretin.x
NDC Package 16781-446-35

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 discontinued by the firm.

Tretin.x is a . Marketed by Onset Dermatologics Llc, this product is identified by NDC 16781-446 and is authorized under FDA application ANDA202209.

Identification & Billing

NDC Package Code
16781-446-35
Package Description
1 TUBE in 1 CARTON / 35 g in 1 TUBE
Product Code
16781-446
11-Digit Billing Format
16781044635
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
35 GM

Clinical Specifications

Proprietary Name
Tretin.x
Dosage Form
-

Regulatory & Marketing

Labeler Name
Onset Dermatologics Llc
FDA Application #
ANDA202209
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-02-2013
End Marketing Date
12-01-2017
Listing Expiration
12-01-2017
Exclude Flag
D
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 16781-446-35 identifies a specific commercial package of 1 tube in 1 carton / 35 g in 1 tube of Tretin.x, labeled by Onset Dermatologics Llc. This product is billed per "GM" gram and contains an estimated amount of 35 billable units per package. 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 Onset Dermatologics Llc on April 02, 2013. The current certification is valid through December 01, 2017.

How is this Onset Dermatologics Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16781044635. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 35 total billable units per package. 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)
16781-446-35
11-Digit CMS (5-4-2)
16781-0446-35

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