Egrifta
NDC Package 44087-2011-2

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.

Egrifta is a medication used to reduce excess fat in the stomach area (abdomen) in people with HIV infection who have changes in the way their body fat is distributed. Marketed by Emd Serono, Inc., this product is identified by NDC 44087-2011 and is authorized under FDA application NDA022505.

Identification & Billing

NDC Package Code
44087-2011-2
Package Description
1 KIT in 1 BOX * 10 mL in 1 BOTTLE (0409-4887-34) * 2 mL in 1 VIAL
Product Code
44087-2011
11-Digit Billing Format
44087201102
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Egrifta
Dosage Form
-
Usage Information
This medication is used to reduce excess fat in the stomach area (abdomen) in people with HIV infection who have changes in the way their body fat is distributed. Some HIV drugs may cause this side effect (increased fat in the upper back and stomach areas, decreased fat in the arms and legs). Tesamorelin works by causing your body to make more growth hormone. This medication should not be used for weight loss.

Regulatory & Marketing

Labeler Name
Emd Serono, Inc.
FDA Application #
NDA022505
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-05-2012
End Marketing Date
10-31-2016
Listing Expiration
10-31-2016
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 44087-2011-2 identifies a specific commercial package of 1 kit in 1 box * 10 ml in 1 bottle (0409-4887-34) * 2 ml in 1 vial of Egrifta, labeled by Emd Serono, 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 Emd Serono, Inc. on September 05, 2012. The current certification is valid through October 31, 2016.

What are the primary indications for this medication?

This medication is used to reduce excess fat in the stomach area (abdomen) in people with HIV infection who have changes in the way their body fat is distributed. Some HIV drugs may cause this side effect (increased fat in the upper back and stomach areas, decreased fat in the arms and legs). Tesamorelin works by causing your body to make more growth hormone. This medication should not be used for weight loss.

How is this Emd Serono, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44087201102. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
44087-2011-2
11-Digit CMS (5-4-2)
44087-2011-02

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