Dronabinol
NDC Package 0527-4125-35

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.

Dronabinol is used to treat nausea and vomiting caused by cancer chemotherapy. Marketed by Lannett Company, Inc., this product is identified by NDC 0527-4125 and is authorized under FDA application ANDA207421.

Identification & Billing

NDC Package Code
0527-4125-35
Package Description
60 CAPSULE in 1 BOTTLE
Product Code
0527-4125
11-Digit Billing Format
00527412535

Clinical Specifications

Proprietary Name
Dronabinol
Dosage Form
-
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).

Regulatory & Marketing

Labeler Name
Lannett Company, Inc.
FDA Application #
ANDA207421
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-10-2020
End Marketing Date
11-30-2023
Listing Expiration
11-30-2023
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 0527-4125-35 identifies a specific commercial package of 60 capsule in 1 bottle of Dronabinol, labeled by Lannett Company, 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 Lannett Company, Inc. on February 10, 2020. The current certification is valid through November 30, 2023.

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 Lannett Company, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00527412535. 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)
0527-4125-35
11-Digit CMS (5-4-2)
00527-4125-35

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