Doxorubicin Hydrochloride Injection, Suspension, Liposomal
NDC Package 12064-019-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Doxorubicin Hydrochloride injection is a drug for further processing. This formulation utilizes a injection, suspension, liposomal delivery system. Marketed by Glaxosmithkline Manufacturing Spa, this product is identified by NDC 12064-019.

Identification & Billing

NDC Package Code
12064-019-01
Package Description
50 VIAL in 1 CASE / 25 mL in 1 VIAL
Product Code
12064-019
11-Digit Billing Format
12064001901

Clinical Specifications

Proprietary Name
Doxorubicin Hydrochloride
Non-Proprietary Name
Doxorubicin Hydrochloride
Substance Name
Doxorubicin Hydrochloride
Dosage Form
Injection, Suspension, Liposomal - A liquid preparation, suitable for injection, which consists of an oil phase dispersed throughout an aqueous phase in such a manner that liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance, either within a lipid bilayer or in an aqueous space) are formed.
Active Ingredient(s)
DOXORUBICIN HYDROCHLORIDE 2 mg/mL

Regulatory & Marketing

Labeler Name
Glaxosmithkline Manufacturing Spa
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
01-01-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (12064-019). Click a package code to view its specific billing and regulatory data.

12064-019-00
98 VIAL in 1 CASE / 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 12064-019-01 identifies a specific commercial package of 50 vial in 1 case / 25 ml in 1 vial of Doxorubicin Hydrochloride (UNFINISHED drug), drug for further processing labeled by Glaxosmithkline Manufacturing Spa. This injection, suspension, liposomal is formulated for use and contains doxorubicin hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Glaxosmithkline Manufacturing Spa on January 01, 2015. The current certification is valid through December 31, 2026.

How is this Glaxosmithkline Manufacturing Spa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12064001901. 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)
12064-019-01
11-Digit CMS (5-4-2)
12064-0019-01

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