Metopirone
NDC Package 0078-0455-17

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.

Metopirone is normally the pituitary gland in your brain sends signals to your adrenal glands to make a natural substance called cortisol. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0455 and is authorized under FDA application NDA012911.

Identification & Billing

NDC Package Code
0078-0455-17
Package Description
18 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
0078-0455
11-Digit Billing Format
00078045517

Clinical Specifications

Proprietary Name
Metopirone
Dosage Form
-
Usage Information
Normally the pituitary gland in your brain sends signals to your adrenal glands to make a natural substance called cortisol. Cortisol is important for keeping your body functioning well and for good health. Metyrapone is used to test if your pituitary gland is sending the proper signals to your adrenal glands.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
FDA Application #
NDA012911
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-25-1962
End Marketing Date
11-30-2012
Listing Expiration
11-30-2012
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 0078-0455-17 identifies a specific commercial package of 18 capsule, gelatin coated in 1 bottle of Metopirone, labeled by Novartis Pharmaceuticals Corporation. 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 Novartis Pharmaceuticals Corporation on January 25, 1962. The current certification is valid through November 30, 2012.

What are the primary indications for this medication?

Normally the pituitary gland in your brain sends signals to your adrenal glands to make a natural substance called cortisol. Cortisol is important for keeping your body functioning well and for good health. Metyrapone is used to test if your pituitary gland is sending the proper signals to your adrenal glands.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078045517. 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)
0078-0455-17
11-Digit CMS (5-4-2)
00078-0455-17

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