Doxorubicin Hydrochloride Injection, Suspension, Liposomal
NDC Package 68001-706-36

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

Package Information

Doxorubicin Hydrochloride injection is doxorubicin hydrochloride liposome injection is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see Warnings and Precautions ( 5.2)]. This formulation utilizes a injection, suspension, liposomal delivery system. Marketed by Bluepoint Laboratories, this product is identified by NDC 68001-706 and is authorized under FDA application ANDA219199.

Identification & Billing

NDC Package Code
68001-706-36
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code
68001-706
11-Digit Billing Format
68001070636

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.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DOXORUBICIN HYDROCHLORIDE 2 mg/mL
Pharmacologic Class
Usage Information
Doxorubicin hydrochloride liposome injection is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see Warnings and Precautions ( 5.2)] .

Regulatory & Marketing

Labeler Name
Bluepoint Laboratories
Product Type
Human Prescription Drug
FDA Application #
ANDA219199
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-10-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68001-706-36 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose of Doxorubicin Hydrochloride, a human prescription drug labeled by Bluepoint Laboratories. 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 Bluepoint Laboratories on July 10, 2026. The current certification is valid through December 31, 2027.

How is this Bluepoint Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68001070636. 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)
68001-706-36
11-Digit CMS (5-4-2)
68001-0706-36

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