Metopirone Capsule, Gelatin Coated
NDC Package 76336-455-18

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

Package Information

Metopirone (metyrapone) capsules is normally the pituitary gland in your brain sends signals to your adrenal glands to make a natural substance called cortisol. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Hra Pharma Rare Diseases, this product is identified by NDC 76336-455 and is authorized under FDA application NDA012911.

Identification & Billing

NDC Package Code
76336-455-18
Package Description
18 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
76336-455
11-Digit Billing Format
76336045518
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
18 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Metopirone
Non-Proprietary Name
Metyrapone
Substance Name
Metyrapone
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METYRAPONE 250 mg/1
Pharmacologic Class
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
Hra Pharma Rare Diseases
Product Type
Human Prescription Drug
FDA Application #
NDA012911
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-25-1962
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76336-455). Click a package code to view its specific billing and regulatory data.

76336-455-17
18 CAPSULE, GELATIN COATED in 1 BOTTLE

* 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 76336-455-18 identifies a specific commercial package of 18 capsule, gelatin coated in 1 bottle of Metopirone, 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 18 billable units per package. This capsule, gelatin coated is formulated for oral use and contains metyrapone 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 January 25, 1962. The current certification is valid through December 31, 2027.

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 Hra Pharma Rare Diseases product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76336045518. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 18 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)
76336-455-18
11-Digit CMS (5-4-2)
76336-0455-18

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