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  5. NDC Package Code: 0338-0067-01 Doxil

NDC Package 0338-0067-01 Doxil

Doxorubicin Hydrochloride Injection, Suspension, Liposomal Intravitreal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0338-0067-01
Package Description:
1 VIAL, SINGLE-USE in 1 CARTON / 25 mL in 1 VIAL, SINGLE-USE
Product Code:
0338-0067
Proprietary Name:
Doxil
Non-Proprietary Name:
Doxorubicin Hydrochloride
Substance Name:
Doxorubicin Hydrochloride
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.
11-Digit NDC Billing Format:
00338006701
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Baxter Healthcare Corporation
    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(s):
  • Intravitreal - Administration within the vitreous body of the eye.
    • Active Ingredient(s):
  • DOXORUBICIN HYDROCHLORIDE 2 mg/mL
    • Pharmacologic Class(es):
  • Anthracycline Topoisomerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Anthracyclines - [CS]
  • Topoisomerase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA050718
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-13-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0338-0067-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00338006701Q2050Doxorubicin inj 10mg10 MG25155

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0338-0067-01?

    The NDC Packaged Code 0338-0067-01 is assigned to a package of 1 vial, single-use in 1 carton / 25 ml in 1 vial, single-use of Doxil, a human prescription drug labeled by Baxter Healthcare Corporation. The product's dosage form is injection, suspension, liposomal and is administered via intravitreal form.

    Is NDC 0338-0067 included in the NDC Directory?

    Yes, Doxil with product code 0338-0067 is active and included in the NDC Directory. The product was first marketed by Baxter Healthcare Corporation on August 13, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0338-0067-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0338-0067-01?

    The 11-digit format is 00338006701. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20338-0067-015-4-200338-0067-01