Rituximab-abbs Injection, Solution, Concentrate
NDC Package 83703-581-84

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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, concentrate delivery system. Marketed by Bamboo Us Bidco Lcc, this product is identified by NDC 83703-581.

Identification & Billing

NDC Package Code
83703-581-84
Package Description
84 VIAL in 1 CARTON / 50 mL in 1 VIAL
Product Code
83703-581
11-Digit Billing Format
83703058184

Clinical Specifications

Proprietary Name
Rituximab-abbs
Non-Proprietary Name
Rituximab-abbs
Substance Name
Rituximab
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Active Ingredient(s)
RITUXIMAB 10 mg/mL
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
Bamboo Us Bidco Lcc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
10-01-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 83703-581-84 identifies a specific commercial package of 84 vial in 1 carton / 50 ml in 1 vial of Rituximab-abbs (UNFINISHED drug), drug for further processing labeled by Bamboo Us Bidco Lcc. This injection, solution, concentrate is formulated for 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 Bamboo Us Bidco Lcc on October 01, 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 Bamboo Us Bidco Lcc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83703058184. 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)
83703-581-84
11-Digit CMS (5-4-2)
83703-0581-84

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