Cesamet
NDC Package 0187-1221-03

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Cesamet is a medication used to treat severe nausea and vomiting caused by cancer drug treatment (chemotherapy). Marketed by Valeant Pharmaceuticals North America Llc, this product is identified by NDC 0187-1221 and is authorized under FDA application NDA018677.

Identification & Billing

NDC Package Code
0187-1221-03
Package Description
50 CAPSULE in 1 BOTTLE
Product Code
0187-1221
11-Digit Billing Format
00187122103

Clinical Specifications

Proprietary Name
Cesamet
Dosage Form
-
Usage Information
This medication is used to treat severe nausea and vomiting caused by cancer drug treatment (chemotherapy). Nabilone is a man-made drug similar to the natural substances found in marijuana (cannabis). It is works by decreasing the signals in the brain that lead to nausea and vomiting.

Regulatory & Marketing

Labeler Name
Valeant Pharmaceuticals North America Llc
FDA Application #
NDA018677
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-2009
End Marketing Date
11-13-2017
Listing Expiration
11-13-2017
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 0187-1221-03 identifies a specific commercial package of 50 capsule in 1 bottle of Cesamet, labeled by Valeant Pharmaceuticals North America Llc. 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 Valeant Pharmaceuticals North America Llc on November 01, 2009. The current certification is valid through November 13, 2017.

What are the primary indications for this medication?

This medication is used to treat severe nausea and vomiting caused by cancer drug treatment (chemotherapy). Nabilone is a man-made drug similar to the natural substances found in marijuana (cannabis). It is works by decreasing the signals in the brain that lead to nausea and vomiting.

How is this Valeant Pharmaceuticals North America Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00187122103. 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 (4-4-2)
0187-1221-03
11-Digit CMS (5-4-2)
00187-1221-03

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