Imbruvica Tablet, Film Coated
NDC Package 57962-014-28

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

Package Information

Imbruvica (ibrutinib) tablets 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 tablet, film coated delivery system. Marketed by Pharmacyclics Llc, this product is identified by NDC 57962-014 and is authorized under FDA application NDA210563.

Identification & Billing

NDC Package Code
57962-014-28
Package Description
1 BLISTER PACK in 1 CARTON / 28 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
57962-014
11-Digit Billing Format
57962001428
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Imbruvica
Non-Proprietary Name
Ibrutinib
Substance Name
Ibrutinib
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
IBRUTINIB 140 mg/1
Pharmacologic Class
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
Pharmacyclics Llc
Product Type
Human Prescription Drug
FDA Application #
NDA210563
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-16-2018
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 57962-014-28 identifies a specific commercial package of 1 blister pack in 1 carton / 28 tablet, film coated in 1 blister pack of Imbruvica, a human prescription drug labeled by Pharmacyclics Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet, film coated is formulated for oral 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 Pharmacyclics Llc on February 16, 2018. The current certification is valid through December 31, 2027.

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 Pharmacyclics Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57962001428. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
57962-014-28
11-Digit CMS (5-4-2)
57962-0014-28

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