Iclusig Tablet, Film Coated
NDC Package 63020-533-30

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

Package Information

Iclusig (ponatinib hydrochloride) tablets is ponatinib is used to treat certain types of blood cancer (chronic myelogenous leukemia-CML, acute lymphoblastic leukemia-ALL). This formulation utilizes a tablet, film coated delivery system. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 63020-533 and is authorized under FDA application NDA203469.

Identification & Billing

NDC Package Code
63020-533-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
63020-533
11-Digit Billing Format
63020053330
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Iclusig
Non-Proprietary Name
Ponatinib Hydrochloride
Substance Name
Ponatinib Hydrochloride
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)
PONATINIB HYDROCHLORIDE 30 mg/1
Pharmacologic Class
Usage Information
Ponatinib is used to treat certain types of blood cancer (chronic myelogenous leukemia-CML, acute lymphoblastic leukemia-ALL). It works by slowing or stopping the growth of cancer cells. It belongs to a class of drugs known as kinase inhibitors.

Regulatory & Marketing

Labeler Name
Takeda Pharmaceuticals America, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA203469
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-22-2015
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 63020-533-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Iclusig, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet, film coated is formulated for oral use and contains ponatinib hydrochloride 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 Takeda Pharmaceuticals America, Inc. on April 22, 2015. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Ponatinib is used to treat certain types of blood cancer (chronic myelogenous leukemia-CML, acute lymphoblastic leukemia-ALL). It works by slowing or stopping the growth of cancer cells. It belongs to a class of drugs known as kinase inhibitors.

How is this Takeda Pharmaceuticals America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63020053330. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
63020-533-30
11-Digit CMS (5-4-2)
63020-0533-30

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