Truxima Injection, Solution
NDC Package 63459-103-10

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

Truxima (rituximab-abbs) injection is rituximab is used to treat certain types of cancer (such as non-Hodgkin's lymphoma, chronic lymphocytic leukemia). This formulation utilizes a injection, solution delivery system. Marketed by Cephalon, Inc., this product is identified by NDC 63459-103 and is authorized under FDA application BLA761088.

Identification & Billing

NDC Package Code
63459-103-10
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-USE
Product Code
63459-103
11-Digit Billing Format
63459010310
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Truxima
Non-Proprietary Name
Rituximab-abbs
Substance Name
Rituximab
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)
RITUXIMAB 10 mg/mL
Pharmacologic Class
Usage Information
Rituximab is used to treat certain types of cancer (such as non-Hodgkin's lymphoma, chronic lymphocytic leukemia). It works by slowing or stopping the growth of cancer cells. Some brands of rituximab are also used to treat rheumatoid arthritis and can decrease joint pain and swelling. This drug is also used to treat certain types of blood vessel disease (such as granulomatosis with polyangiitis, microscopic polyangiitis) and can decrease the swelling of the blood vessels. Rituximab is also used to treat a certain skin condition (pemphigus vulgaris). It helps to reduce the number of skin lesions. This monograph is about the following rituximab products: rituximab, rituximab-abbs, and rituximab-pvvr.

Regulatory & Marketing

Labeler Name
Cephalon, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761088
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-04-2020
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.

Q5115
Source: ASP
Inj truxima 10 mg
HCPCS Dosage 10 MG
Units / Pkg 10

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 63459-103-10 identifies a specific commercial package of 1 vial, single-use in 1 carton / 10 ml in 1 vial, single-use of Truxima, a human prescription drug labeled by Cephalon, Inc.. This injection, solution is formulated for intravenous use and contains rituximab 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 Cephalon, Inc. on May 04, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Rituximab is used to treat certain types of cancer (such as non-Hodgkin's lymphoma, chronic lymphocytic leukemia). It works by slowing or stopping the growth of cancer cells. Some brands of rituximab are also used to treat rheumatoid arthritis and can decrease joint pain and swelling. This drug is also used to treat certain types of blood vessel disease (such as granulomatosis with polyangiitis, microscopic polyangiitis) and can decrease the swelling of the blood vessels. Rituximab is also used to treat a certain skin condition (pemphigus vulgaris). It helps to reduce the number of skin lesions. This monograph is about the following rituximab products: rituximab, rituximab-abbs, and rituximab-pvvr.

How is this Cephalon, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63459010310. 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)
63459-103-10
11-Digit CMS (5-4-2)
63459-0103-10

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