Doxorubicin Hydrochloride Injection, Solution
NDC Package 63323-101-61

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

Doxorubicin Hydrochloride injection is uSP has been used successfully to produce regression in disseminated neoplastic conditions such as acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms'  tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin's disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types.Doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary breast cancer. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-101 and is authorized under FDA application ANDA063277.

Identification & Billing

NDC Package Code
63323-101-61
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 100 mL in 1 VIAL, MULTI-DOSE
Product Code
63323-101
11-Digit Billing Format
63323010161
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Doxorubicin Hydrochloride
Non-Proprietary Name
Doxorubicin Hydrochloride
Substance Name
Doxorubicin Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
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 Injection, USP has been used successfully to produce regression in disseminated neoplastic conditions such as acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms'  tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin's disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types.Doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary breast cancer.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA063277
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-14-2000
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.

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.

J9000
Source: ASP
Doxorubicin hcl injection
HCPCS Dosage 10 MG
Units / Pkg 20

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 63323-101-61 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 100 ml in 1 vial, multi-dose of Doxorubicin Hydrochloride, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, solution 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 Fresenius Kabi Usa, Llc on June 14, 2000. The current certification is valid through December 31, 2026.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323010161. 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 (5-3-2)
63323-101-61
11-Digit CMS (5-4-2)
63323-0101-61

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