Nilotinib Capsule
NDC Package 13668-710-91

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 are contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning]. This formulation utilizes a capsule delivery system. Marketed by Torrent Pharmaceuticals Limited, this product is identified by NDC 13668-710 and is authorized under FDA application ANDA218532.

Identification & Billing

NDC Package Code
13668-710-91
Package Description
1 BLISTER PACK in 1 CARTON / 28 CAPSULE in 1 BLISTER PACK
Product Code
13668-710
11-Digit Billing Format
13668071091
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nilotinib
Non-Proprietary Name
Nilotinib
Substance Name
Nilotinib Hydrochloride Monohydrate
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 HYDROCHLORIDE MONOHYDRATE 150 mg/1
Pharmacologic Class
Usage Information
Nilotinib capsules are contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning].

Regulatory & Marketing

Labeler Name
Torrent Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA218532
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-16-2025
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 (13668-710). Click a package code to view its specific billing and regulatory data.

13668-710-57
4 BLISTER PACK in 1 CARTON / 28 CAPSULE in 1 BLISTER PACK

* 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 13668-710-91 identifies a specific commercial package of 1 blister pack in 1 carton / 28 capsule in 1 blister pack of Nilotinib, a human prescription drug labeled by Torrent Pharmaceuticals Limited. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This capsule is formulated for oral use and contains nilotinib hydrochloride monohydrate 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 Torrent Pharmaceuticals Limited on December 16, 2025. The current certification is valid through December 31, 2026.

How is this Torrent Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13668071091. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
13668-710-91
11-Digit CMS (5-4-2)
13668-0710-91

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