Doxil Injection, Suspension, Liposomal
NDC Package 0338-9665-01

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

Package Information

Doxil (doxorubicin hydrochloride) injection is liposomal doxorubicin is an anthracycline-type chemotherapy drug that is used to treat certain types of cancer (e.g., ovarian cancer, AIDS-related Kaposi's sarcoma, multiple myeloma). This formulation utilizes a injection, suspension, liposomal delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-9665 and is authorized under FDA application NDA050718.

Identification & Billing

NDC Package Code
0338-9665-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 25 mL in 1 VIAL, SINGLE-DOSE
Product Code
0338-9665
11-Digit Billing Format
00338966501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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
  • RxCUI: 1790127 - DOXOrubicin HCl liposome 50 MG in 25 ML Injection
  • RxCUI: 1790127 - 25 ML doxorubicin hydrochloride liposome 2 MG/ML Injection

Clinical Specifications

Proprietary Name
Doxil
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
Usage Information
Liposomal doxorubicin is an anthracycline-type chemotherapy drug that is used to treat certain types of cancer (e.g., ovarian cancer, AIDS-related Kaposi's sarcoma, multiple myeloma). It works by slowing or stopping cancer cell growth.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA050718
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-26-2024
Listing Expiration
12-31-2027
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

Q2050
Source: ASP
Doxorubicin inj 10mg
HCPCS Dosage 10 MG
Units / Pkg 5

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 0338-9665-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 25 ml in 1 vial, single-dose of Doxil, 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 August 26, 2024. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Liposomal doxorubicin is an anthracycline-type chemotherapy drug that is used to treat certain types of cancer (e.g., ovarian cancer, AIDS-related Kaposi's sarcoma, multiple myeloma). It works by slowing or stopping cancer cell growth.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338966501. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0338-9665-01
11-Digit CMS (5-4-2)
00338-9665-01

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