Rituximab Solution
NDC Package 12714-214-10

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 solution is rituximab is used to treat certain types of cancer (such as non-Hodgkin's lymphoma, chronic lymphocytic leukemia). This formulation utilizes a solution delivery system. Marketed by Boehringer Ingelheim Pharma Gmbh And Co. Kg, this product is identified by NDC 12714-214.

Identification & Billing

NDC Package Code
12714-214-10
Package Description
100 mg in 1 TANK
Product Code
12714-214
11-Digit Billing Format
12714021410

Clinical Specifications

Proprietary Name
Rituximab
Non-Proprietary Name
Rituximab
Substance Name
Rituximab
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Active Ingredient(s)
RITUXIMAB 100 mg/100mg
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
Boehringer Ingelheim Pharma Gmbh And Co. Kg
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-23-2019
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 12714-214-10 identifies a specific commercial package of 100 mg in 1 tank of Rituximab (UNFINISHED drug), a bulk ingredient labeled by Boehringer Ingelheim Pharma Gmbh And Co. Kg. This solution 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 Boehringer Ingelheim Pharma Gmbh And Co. Kg on July 23, 2019. 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 Boehringer Ingelheim Pharma Gmbh And Co. Kg product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12714021410. 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)
12714-214-10
11-Digit CMS (5-4-2)
12714-0214-10

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