Nilotinib Capsule
NDC Package 72205-237-92

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

Package Information

Nilotinib capsules is nilotinib is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning]. This formulation utilizes a capsule delivery system. Marketed by Novadoz Pharmaceuticals Llc, this product is identified by NDC 72205-237 and is authorized under FDA application ANDA218544.

Identification & Billing

NDC Package Code
72205-237-92
Package Description
120 CAPSULE in 1 BOTTLE
Product Code
72205-237
11-Digit Billing Format
72205023792
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nilotinib
Non-Proprietary Name
Nilotinib
Substance Name
Nilotinib
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NILOTINIB 50 mg/1
Pharmacologic Class
Usage Information
Nilotinib is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning].

Regulatory & Marketing

Labeler Name
Novadoz Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA218544
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-19-2025
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 72205-237-92 identifies a specific commercial package of 120 capsule in 1 bottle of Nilotinib, a human prescription drug labeled by Novadoz Pharmaceuticals Llc. This capsule 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 Novadoz Pharmaceuticals Llc on November 19, 2025. The current certification is valid through December 31, 2026.

How is this Novadoz Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72205023792. 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)
72205-237-92
11-Digit CMS (5-4-2)
72205-0237-92

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