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  5. NDC Package Code: 69097-032-91 Nilotinib

NDC Package 69097-032-91 Nilotinib

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
69097-032-91
Package Description:
28 CAPSULE in 1 BLISTER PACK
Product Code:
69097-032
Proprietary Name:
Nilotinib
Non-Proprietary Name:
Nilotinib
Substance Name:
Nilotinib
Usage Information:
Nilotinib Capsules is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning and Warnings and Precautions (5.2)].  
11-Digit NDC Billing Format:
69097003291
Product Type:
Human Prescription Drug
Labeler Name:
Cipla Usa Inc.
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
NILOTINIB 200 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA218922
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
06-18-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
69097-032-564 BLISTER PACK in 1 CARTON / 28 CAPSULE in 1 BLISTER PACK
69097-032-732 BLISTER PACK in 1 CARTON / 28 CAPSULE in 1 BLISTER PACK
69097-032-7428 CAPSULE in 1 BLISTER PACK

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 69097-032-91?

The NDC Packaged Code 69097-032-91 is assigned to a package of 28 capsule in 1 blister pack of Nilotinib, a human prescription drug labeled by Cipla Usa Inc.. The product's dosage form is capsule and is administered via oral form.

Is NDC 69097-032 included in the NDC Directory?

Yes, Nilotinib with product code 69097-032 is active and included in the NDC Directory. The product was first marketed by Cipla Usa Inc. on June 18, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 69097-032-91?

The 11-digit format is 69097003291. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-269097-032-915-4-269097-0032-91