Gonal-f Rff Pen
NDC Package 44087-1113-1

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 discontinued by the firm.

Gonal-f Rff Pen is a . Marketed by Emd Serono, Inc., this product is identified by NDC 44087-1113 and is authorized under FDA application NDA021684.

Identification & Billing

NDC Package Code
44087-1113-1
Package Description
1 CARTRIDGE in 1 CARTON / .5 mL in 1 CARTRIDGE
Product Code
44087-1113
11-Digit Billing Format
44087111301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Gonal-f Rff Pen
Dosage Form
-

Regulatory & Marketing

Labeler Name
Emd Serono, Inc.
FDA Application #
NDA021684
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-25-2004
End Marketing Date
12-31-2016
Listing Expiration
12-31-2016
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 44087-1113-1 identifies a specific commercial package of 1 cartridge in 1 carton / .5 ml in 1 cartridge of Gonal-f Rff Pen, 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 May 25, 2004. The current certification is valid through December 31, 2016.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44087111301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
44087-1113-1
11-Digit CMS (5-4-2)
44087-1113-01

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