Triheptanoin Oil
NDC Package 53194-000-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Triheptanoin oils is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a oil delivery system. Marketed by Ioi Oleo Gmbh, this product is identified by NDC 53194-000.

Identification & Billing

NDC Package Code
53194-000-01
Package Description
930 kg in 1 CONTAINER
Product Code
53194-000
11-Digit Billing Format
53194000001

Clinical Specifications

Proprietary Name
Triheptanoin
Non-Proprietary Name
Triheptanoin
Substance Name
Triheptanoin
Dosage Form
Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.
Active Ingredient(s)
TRIHEPTANOIN 1 kg/kg

Regulatory & Marketing

Labeler Name
Ioi Oleo Gmbh
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-20-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 53194-000-01 identifies a specific commercial package of 930 kg in 1 container of Triheptanoin (UNFINISHED drug), a bulk ingredient labeled by Ioi Oleo Gmbh. This oil is formulated for use and contains triheptanoin 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 Ioi Oleo Gmbh on February 20, 2013. The current certification is valid through December 31, 2026.

How is this Ioi Oleo Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53194000001. 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)
53194-000-01
11-Digit CMS (5-4-2)
53194-0000-01

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