Doxorubicin Hydrochloride
NDC Package 67457-478-10

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.

Doxorubicin Hydrochloride is uSP is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer [see Clinical Studies (14)]. Marketed by Mylan Institutional Llc, this product is identified by NDC 67457-478 and is authorized under FDA application ANDA200170.

Identification & Billing

NDC Package Code
67457-478-10
Package Description
1 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code
67457-478
11-Digit Billing Format
67457047810
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Doxorubicin Hydrochloride
Dosage Form
-
Usage Information
Doxorubicin hydrochloride, USP is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Mylan Institutional Llc
FDA Application #
ANDA200170
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-22-2014
End Marketing Date
08-31-2018
Listing Expiration
08-31-2018
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 67457-478-10 identifies a specific commercial package of 1 vial in 1 carton / 5 ml in 1 vial of Doxorubicin Hydrochloride, labeled by Mylan Institutional Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 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 Mylan Institutional Llc on May 22, 2014. The current certification is valid through August 31, 2018.

How is this Mylan Institutional Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67457047810. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
67457-478-10
11-Digit CMS (5-4-2)
67457-0478-10

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