Lysodren Tablet
NDC Package 76336-080-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lysodren (mitotane) tablets is mitotane is used to treat cancer of the adrenal glands. This formulation utilizes a tablet delivery system. Marketed by Hra Pharma Rare Diseases, this product is identified by NDC 76336-080 and is authorized under FDA application NDA016885.

Identification & Billing

NDC Package Code
76336-080-60
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE
Product Code
76336-080
11-Digit Billing Format
76336008060
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lysodren
Non-Proprietary Name
Mitotane
Substance Name
Mitotane
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MITOTANE 500 mg/1
Pharmacologic Class
Cytochrome P450 3A4 Inducers - [MoA] (Mechanism of Action)
Usage Information
Mitotane is used to treat cancer of the adrenal glands. It works by slowing the growth of or killing adrenal gland cells and also decreases the amount of hormones made by the adrenal gland.

Regulatory & Marketing

Labeler Name
Hra Pharma Rare Diseases
Product Type
Human Prescription Drug
FDA Application #
NDA016885
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-15-1978
Listing Expiration
12-31-2026
Exclude Flag
N
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 76336-080-60 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet in 1 bottle of Lysodren, a human prescription drug labeled by Hra Pharma Rare Diseases. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet is formulated for oral use and contains mitotane 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 Hra Pharma Rare Diseases on October 15, 1978. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Mitotane is used to treat cancer of the adrenal glands. It works by slowing the growth of or killing adrenal gland cells and also decreases the amount of hormones made by the adrenal gland.

How is this Hra Pharma Rare Diseases product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76336008060. 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 (5-3-2)
76336-080-60
11-Digit CMS (5-4-2)
76336-0080-60

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