Doxorubicin Hydrochloride, Liposomal Injection, Suspension, Liposomal
NDC Package 0338-9581-02

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

Package Information

Doxorubicin Hydrochloride, Liposomal (doxorubicin hydrochloride) injection is classified as a

administered via intravenous route. This formulation utilizes a injection, suspension, liposomal delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-9581.

Identification & Billing

NDC Package Code
0338-9581-02
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-USE (0338-9581-01)
Product Code
0338-9581
11-Digit Billing Format
00338958102
RxNorm Crosswalk
  • RxCUI: 1790115 - DOXOrubicin HCl liposome 20 MG in 10 ML Injection
  • RxCUI: 1790115 - 10 ML doxorubicin hydrochloride liposome 2 MG/ML Injection
  • RxCUI: 1790115 - doxorubicin hydrochloride liposome 20 MG per 10 ML Injection

Clinical Specifications

Proprietary Name
Doxorubicin Hydrochloride, Liposomal
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.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DOXORUBICIN HYDROCHLORIDE 2 mg/mL
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE -
Start Marketing Date
12-19-2023
Listing Expiration
12-31-2026
Exclude Flag
N
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 0338-9581-02 identifies a specific commercial package of 1 vial, single-use in 1 carton / 10 ml in 1 vial, single-use (0338-9581-01) of Doxorubicin Hydrochloride, Liposomal, a human prescription drug labeled by Baxter Healthcare Corporation. This injection, suspension, liposomal is formulated for intravenous 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 Baxter Healthcare Corporation on December 19, 2023. The current certification is valid through December 31, 2026.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338958102. 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)
0338-9581-02
11-Digit CMS (5-4-2)
00338-9581-02

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