Fuzeon
NDC Package 0004-0380-39

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.

Fuzeon is a medication used with other HIV medications to help control HIV infection. Marketed by Genentech, Inc., this product is identified by NDC 0004-0380 and is authorized under FDA application NDA021481.

Identification & Billing

NDC Package Code
0004-0380-39
Package Description
1 KIT in 1 CARTON * 1 SWAB in 1 PACKET * 1 mL in 1 VIAL, SINGLE-DOSE * 1 mL in 1 VIAL, SINGLE-USE
Product Code
0004-0380
11-Digit Billing Format
00004038039
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Fuzeon
Dosage Form
-
Usage Information
This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Enfuvirtide is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

Regulatory & Marketing

Labeler Name
Genentech, Inc.
FDA Application #
NDA021481
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-13-2003
End Marketing Date
11-13-2013
Listing Expiration
11-13-2013
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 0004-0380-39 identifies a specific commercial package of 1 kit in 1 carton * 1 swab in 1 packet * 1 ml in 1 vial, single-dose * 1 ml in 1 vial, single-use of Fuzeon, labeled by Genentech, 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 Genentech, Inc. on March 13, 2003. The current certification is valid through November 13, 2013.

What are the primary indications for this medication?

This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Enfuvirtide is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00004038039. 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 (4-4-2)
0004-0380-39
11-Digit CMS (5-4-2)
00004-0380-39

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