Daunoxome
NDC Package 10885-001-01

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.

Daunoxome is a . Marketed by Galen Us Inc, this product is identified by NDC 10885-001 and is authorized under FDA application NDA050704.

Identification & Billing

NDC Package Code
10885-001-01
Package Description
25 mL in 1 VIAL, SINGLE-USE
Product Code
10885-001
11-Digit Billing Format
10885000101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
25 ML

Clinical Specifications

Proprietary Name
Daunoxome
Dosage Form
-

Regulatory & Marketing

Labeler Name
Galen Us Inc
FDA Application #
NDA050704
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-13-2012
End Marketing Date
04-16-2016
Listing Expiration
04-16-2016
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 10885-001-01 identifies a specific commercial package of 25 ml in 1 vial, single-use of Daunoxome, labeled by Galen Us Inc. This product is billed per "ML" milliliter and contains an estimated amount of 25 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 Galen Us Inc on February 13, 2012. The current certification is valid through April 16, 2016.

How is this Galen Us Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10885000101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 25 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)
10885-001-01
11-Digit CMS (5-4-2)
10885-0001-01

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