Amevive
NDC Package 0469-0021-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Amevive is a . Marketed by Astellas Pharma Us Inc., this product is identified by NDC 0469-0021 and is authorized under FDA application BLA125036.

Identification & Billing

NDC Package Code
0469-0021-04
Package Description
1 KIT in 1 CARTON * .5 mL in 1 VIAL * 10 mL in 1 VIAL
Product Code
0469-0021
11-Digit Billing Format
00469002104
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Amevive
Dosage Form
-

Regulatory & Marketing

Labeler Name
Astellas Pharma Us Inc.
FDA Application #
BLA125036
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-30-2003
End Marketing Date
05-31-2013
Listing Expiration
05-31-2013
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0469-0021). Click a package code to view its specific billing and regulatory data.

0469-0021-03
4 PACKAGE in 1 CARTON / 1 KIT in 1 PACKAGE * .5 mL in 1 VIAL * 10 mL in 1 VIAL

* 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 0469-0021-04 identifies a specific commercial package of 1 kit in 1 carton * .5 ml in 1 vial * 10 ml in 1 vial of Amevive, labeled by Astellas Pharma Us 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 Astellas Pharma Us Inc. on January 30, 2003. The current certification is valid through May 31, 2013.

How is this Astellas Pharma Us Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00469002104. 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)
0469-0021-04
11-Digit CMS (5-4-2)
00469-0021-04

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