Syndros
NDC Package 20482-335-30

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 inactivated by the FDA.

Syndros is dronabinol is used to treat nausea and vomiting caused by cancer chemotherapy. Marketed by Insys Therapeutics, Inc., this product is identified by NDC 20482-335 and is authorized under FDA application NDA205525.

Identification & Billing

NDC Package Code
20482-335-30
Package Description
1 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS
Product Code
20482-335
11-Digit Billing Format
20482033530
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Syndros
Dosage Form
-
Usage Information
Dronabinol is used to treat nausea and vomiting caused by cancer chemotherapy. It is used when other drugs usually used to control nausea and vomiting have not worked well. Dronabinol is also used to treat loss of appetite and weight loss in people with HIV infection. Dronabinol (also called THC) is a man-made form of a natural substance in marijuana (cannabis).

Regulatory & Marketing

Labeler Name
Insys Therapeutics, Inc.
FDA Application #
NDA205525
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-27-2017
Listing Expiration
12-31-2020
Exclude Flag
I
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 20482-335-30 identifies a specific commercial package of 1 bottle, glass in 1 carton / 30 ml in 1 bottle, glass of Syndros, labeled by Insys Therapeutics, Inc.. 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 Insys Therapeutics, Inc. on July 27, 2017. The current certification is valid through December 31, 2020.

What are the primary indications for this medication?

Dronabinol is used to treat nausea and vomiting caused by cancer chemotherapy. It is used when other drugs usually used to control nausea and vomiting have not worked well. Dronabinol is also used to treat loss of appetite and weight loss in people with HIV infection. Dronabinol (also called THC) is a man-made form of a natural substance in marijuana (cannabis).

How is this Insys Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 20482033530. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
20482-335-30
11-Digit CMS (5-4-2)
20482-0335-30

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