Omcazio Capsule
NDC Package 17201-012-30

11-digit billing NDC: 17201001230
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Omcazio (cabozantinib laurylsulfate) capsules is none. This formulation utilizes a capsule delivery system. Marketed by Handa Pharma, this product is identified by NDC 17201-012 and is authorized under FDA application NDA220613.

Identification & Billing

NDC Package Code
17201-012-30
Package Description
1 BOTTLE in 1 CARTON / 30 CAPSULE in 1 BOTTLE
Product Code
17201-012
11-Digit Billing Format
17201001230

Clinical Specifications

Proprietary Name
Omcazio
Non-Proprietary Name
Cabozantinib Laurylsulfate
Substance Name
Cabozantinib Laurylsulfate
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)
CABOZANTINIB LAURYLSULFATE 23 mg/1
Pharmacologic Class
Usage Information
None.

Regulatory & Marketing

Labeler Name
Handa Pharma
Product Type
Human Prescription Drug
FDA Application #
NDA220613
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-2026
Listing Expiration
12-31-2027
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 17201-012-30 identifies a specific commercial package of 1 bottle in 1 carton / 30 capsule in 1 bottle of Omcazio, a human prescription drug labeled by Handa Pharma. This capsule is formulated for oral use and contains cabozantinib laurylsulfate 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 Handa Pharma on November 01, 2026. The current certification is valid through December 31, 2027.

How is this Handa Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17201001230. 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)
17201-012-30
11-Digit CMS (5-4-2)
17201-0012-30

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