Nilotinib Capsule
NDC Package 69097-032-91

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

Package Information

Nilotinib capsules is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning and Warnings and Precautions (5.2)].  . This formulation utilizes a capsule delivery system. Marketed by Cipla Usa Inc., this product is identified by NDC 69097-032 and is authorized under FDA application NDA218922.

Identification & Billing

NDC Package Code
69097-032-91
Package Description
4 CARTON in 1 CARTON / 2 BLISTER PACK in 1 CARTON (69097-032-73) / 14 CAPSULE in 1 BLISTER PACK (69097-032-76)
Product Code
69097-032
11-Digit Billing Format
69097003291
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 200 mg/1
Pharmacologic Class
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
Cipla Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA218922
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-18-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69097-032). Click a package code to view its specific billing and regulatory data.

69097-032-74
4 CARTON in 1 CARTON / 4 BLISTER PACK in 1 CARTON (69097-032-56) / 7 CAPSULE in 1 BLISTER PACK (69097-032-17)

* 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 69097-032-91 identifies a specific commercial package of 4 carton in 1 carton / 2 blister pack in 1 carton (69097-032-73) / 14 capsule in 1 blister pack (69097-032-76) of Nilotinib, a human prescription drug labeled by Cipla Usa Inc.. 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 Cipla Usa Inc. on June 18, 2025. The current certification is valid through December 31, 2026.

How is this Cipla Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097003291. 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)
69097-032-91
11-Digit CMS (5-4-2)
69097-0032-91

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