6 % Tetrahydrocannabinol In Sesame Oil
NDC Package 49812-0113-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

6 % Tetrahydrocannabinol In Sesame Oil oils is dronabinol is used to treat nausea and vomiting caused by cancer chemotherapy. This formulation utilizes a oil delivery system. Marketed by Veranova, L.p., this product is identified by NDC 49812-0113.

Identification & Billing

NDC Package Code
49812-0113-1
Package Description
1 CONTAINER in 1 CONTAINER / 1 g in 1 CONTAINER
Product Code
49812-0113
11-Digit Billing Format
49812011301

Clinical Specifications

Proprietary Name
6 % Tetrahydrocannabinol In Sesame Oil
Non-Proprietary Name
6 % Tetrahydrocannabinol In Sesame Oil
Substance Name
Dronabinol
Dosage Form
Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.
Active Ingredient(s)
DRONABINOL 1 g/g
Usage Information
Dronabinol is used to treat nausea and vomiting caused by cancer chemotherapy. It is usually used when other drugs to control nausea and vomiting have not been successful. Dronabinol is also used to treat loss of appetite and weight loss in patients with HIV infection. Dronabinol (also called THC) is a man-made form of the active natural substance in marijuana (cannabis).
DEA Schedule
Schedule I (CI) Substance

Regulatory & Marketing

Labeler Name
Veranova, L.p.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-01-2008
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 49812-0113-1 identifies a specific commercial package of 1 container in 1 container / 1 g in 1 container of 6 % Tetrahydrocannabinol In Sesame Oil (UNFINISHED drug), a bulk ingredient labeled by Veranova, L.p.. This oil is formulated for use and contains dronabinol 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 Veranova, L.p. on January 01, 2008. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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

How is this Veranova, L.p. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49812011301. 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 (5-4-1)
49812-0113-1
11-Digit CMS (5-4-2)
49812-0113-01

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