Cavhanza Tablet, Orally Disintegrating
NDC Package 70709-192-12

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

Package Information

Cavhanza (nilotinib) tablets is cAVHANZA is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. This formulation utilizes a tablet, orally disintegrating delivery system. Marketed by Cycle Pharmaceuticals Ltd, this product is identified by NDC 70709-192 and is authorized under FDA application NDA217379.

Identification & Billing

NDC Package Code
70709-192-12
Package Description
112 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Product Code
70709-192
11-Digit Billing Format
70709019212
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
112 EA

Clinical Specifications

Proprietary Name
Cavhanza
Non-Proprietary Name
Nilotinib
Substance Name
Nilotinib
Dosage Form
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NILOTINIB 80 mg/1
Pharmacologic Class
Usage Information
CAVHANZA is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

Regulatory & Marketing

Labeler Name
Cycle Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
NDA217379
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-30-2026
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 70709-192-12 identifies a specific commercial package of 112 tablet, orally disintegrating in 1 bottle of Cavhanza, a human prescription drug labeled by Cycle Pharmaceuticals Ltd. This product is billed for "EA" each discreet unit and contains an estimated amount of 112 billable units per package. This tablet, orally disintegrating is formulated for oral use and contains nilotinib 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 Cycle Pharmaceuticals Ltd on June 30, 2026. The current certification is valid through December 31, 2027.

How is this Cycle Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70709019212. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 112 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)
70709-192-12
11-Digit CMS (5-4-2)
70709-0192-12

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