Danziten Tablet
NDC Package 24338-155-01

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

Package Information

Danziten (nilotinib) tablets is dANZITEN is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning and Warnings and Precautions (5.3)]. This formulation utilizes a tablet delivery system. Marketed by Azurity Pharmaceuticals, Inc., this product is identified by NDC 24338-155 and is authorized under FDA application NDA219293.

Identification & Billing

NDC Package Code
24338-155-01
Package Description
4 CARTON in 1 CARTON / 2 BLISTER PACK in 1 CARTON (24338-155-02) / 14 TABLET in 1 BLISTER PACK (24338-155-03)
Product Code
24338-155
11-Digit Billing Format
24338015501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Danziten
Non-Proprietary Name
Nilotinib
Substance Name
Nilotinib
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NILOTINIB 95 mg/1
Pharmacologic Class
Usage Information
DANZITEN is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning and Warnings and Precautions (5.3)].

Regulatory & Marketing

Labeler Name
Azurity Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA219293
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-30-2024
Listing Expiration
12-31-2026
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 24338-155-01 identifies a specific commercial package of 4 carton in 1 carton / 2 blister pack in 1 carton (24338-155-02) / 14 tablet in 1 blister pack (24338-155-03) of Danziten, a human prescription drug labeled by Azurity Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package. This tablet 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 Azurity Pharmaceuticals, Inc. on November 30, 2024. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 24338015501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 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)
24338-155-01
11-Digit CMS (5-4-2)
24338-0155-01

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