Ibrutinib Powder
NDC Package 68554-0109-1

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.

Ibrutinib powders is a medication used to treat certain cancers (such as mantle cell or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrom's macroglobulinemia). This formulation utilizes a powder delivery system. Marketed by Hetero Labs Limited, this product is identified by NDC 68554-0109.

Identification & Billing

NDC Package Code
68554-0109-1
Package Description
10 kg in 1 DRUM
Product Code
68554-0109
11-Digit Billing Format
68554010901

Clinical Specifications

Proprietary Name
Ibrutinib
Non-Proprietary Name
Ibrutinib
Substance Name
Ibrutinib
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
IBRUTINIB 1 kg/kg
Usage Information
This medication is used to treat certain cancers (such as mantle cell or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrom's macroglobulinemia). Ibrutinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells. Ibrutinib is also used to treat a certain problem that may occur after a stem cell transplant (chronic graft versus host disease). It works by weakening your body's defense system (immune system).

Regulatory & Marketing

Labeler Name
Hetero Labs Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
11-13-2013
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 68554-0109-1 identifies a specific commercial package of 10 kg in 1 drum of Ibrutinib (UNFINISHED drug), a bulk ingredient labeled by Hetero Labs Limited. This powder is formulated for use and contains ibrutinib 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 Hetero Labs Limited on November 13, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain cancers (such as mantle cell or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrom's macroglobulinemia). Ibrutinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells. Ibrutinib is also used to treat a certain problem that may occur after a stem cell transplant (chronic graft versus host disease). It works by weakening your body's defense system (immune system).

How is this Hetero Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68554010901. 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 (5-4-1)
68554-0109-1
11-Digit CMS (5-4-2)
68554-0109-01

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