Metyrosine Capsule
NDC Package 68682-310-01

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

Package Information

Metyrosine capsules is a medication used to treat high blood pressure in people with a certain adrenal gland tumor (pheochromocytoma). This formulation utilizes a capsule delivery system. Marketed by Oceanside Pharmaceuticals, this product is identified by NDC 68682-310 and is authorized under FDA application NDA017871.

Identification & Billing

NDC Package Code
68682-310-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
68682-310
11-Digit Billing Format
68682031001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Metyrosine
Non-Proprietary Name
Metyrosine
Substance Name
Metyrosine
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METYROSINE 250 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat high blood pressure in people with a certain adrenal gland tumor (pheochromocytoma). Metyrosine is used to prevent high blood pressure before and immediately after surgery to remove the tumor. It is also used long-term in people who cannot have the surgery. It is not used for other kinds of high blood pressure. Metyrosine prevents the tumor from making certain natural substances (catecholamines) that raise the blood pressure and make the heart beat faster. Lowering the amount of catecholamines lessens the risk of a very serious attack of high blood pressure (hypertensive crisis).

Regulatory & Marketing

Labeler Name
Oceanside Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA017871
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
09-07-2020
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 68682-310-01 identifies a specific commercial package of 100 capsule in 1 bottle of Metyrosine, a human prescription drug labeled by Oceanside Pharmaceuticals. This capsule is formulated for oral use and contains metyrosine 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 Oceanside Pharmaceuticals on September 07, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat high blood pressure in people with a certain adrenal gland tumor (pheochromocytoma). Metyrosine is used to prevent high blood pressure before and immediately after surgery to remove the tumor. It is also used long-term in people who cannot have the surgery. It is not used for other kinds of high blood pressure. Metyrosine prevents the tumor from making certain natural substances (catecholamines) that raise the blood pressure and make the heart beat faster. Lowering the amount of catecholamines lessens the risk of a very serious attack of high blood pressure (hypertensive crisis).

How is this Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682031001. 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)
68682-310-01
11-Digit CMS (5-4-2)
68682-0310-01

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