Cesamet
NDC Package 0037-1221-50

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 Meda Pharmaceuticals, this product is identified by NDC 0037-1221 and is authorized under FDA application NDA018677.

Identification & Billing

NDC Package Code
0037-1221-50
Package Description
1 BOTTLE in 1 CARTON / 50 CAPSULE in 1 BOTTLE
Product Code
0037-1221
11-Digit Billing Format
00037122150
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

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
Meda Pharmaceuticals
FDA Application #
NDA018677
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-01-2010
End Marketing Date
03-31-2020
Listing Expiration
03-31-2020
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 0037-1221-50 identifies a specific commercial package of 1 bottle in 1 carton / 50 capsule in 1 bottle of Cesamet, labeled by Meda Pharmaceuticals. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Meda Pharmaceuticals on March 01, 2010. The current certification is valid through March 31, 2020.

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 Meda Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00037122150. 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 (4-4-2)
0037-1221-50
11-Digit CMS (5-4-2)
00037-1221-50

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