Nilotinib
NDC Package 76282-790-58

11-digit billing NDC: 76282079058 · Billing unit: EA · 112 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Nilotinib is capsules is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning and Warnings and Precautions (5.2)].  . Marketed by Exelan Pharmaceuticals Inc., this product is identified by NDC 76282-790 and is authorized under FDA application NDA218922.

Identification & Billing

NDC Package Code
76282-790-58
Package Description
4 CARTON in 1 CARTON / 4 BLISTER PACK in 1 CARTON (76282-790-46) / 7 CAPSULE in 1 BLISTER PACK (76282-790-45)
Product Code
76282-790
11-Digit Billing Format
76282079058
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
Nilotinib
Dosage Form
-
Usage Information
Nilotinib Capsules is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning and Warnings and Precautions (5.2)].  

Regulatory & Marketing

Labeler Name
Exelan Pharmaceuticals Inc.
FDA Application #
NDA218922
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-14-2025
End Marketing Date
03-31-2026
Listing Expiration
03-31-2026
Exclude Flag
D
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 76282-790-58 identifies a specific commercial package of 4 carton in 1 carton / 4 blister pack in 1 carton (76282-790-46) / 7 capsule in 1 blister pack (76282-790-45) of Nilotinib, labeled by Exelan Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 112 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Exelan Pharmaceuticals Inc. on November 14, 2025. The current certification is valid through March 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76282079058. 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)
76282-790-58
11-Digit CMS (5-4-2)
76282-0790-58

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