Intralipid Emulsion
NDC Package 65219-539-10

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

Package Information

Intralipid (i.v. fat emulsion) emulsions is a medication used to provide calories to patients who are getting their nutrition through an injection into the vein. This formulation utilizes a emulsion delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 65219-539 and is authorized under FDA application NDA020248.

Identification & Billing

NDC Package Code
65219-539-10
Package Description
6 BAG in 1 CASE / 1000 mL in 1 BAG (65219-539-01)
Product Code
65219-539
11-Digit Billing Format
65219053910
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Intralipid
Non-Proprietary Name
I.v. Fat Emulsion
Substance Name
Soybean Oil
Dosage Form
Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
SOYBEAN OIL 20 g/100mL
Pharmacologic Class
Usage Information
This product is used to provide calories to patients who are getting their nutrition through an injection into the vein. Calories are needed to provide the body with energy so that the body can work properly. This product is also used to provide a certain nutrient (essential fatty acids) to people who do not have enough of it. This product helps to prevent or reverse the signs of this deficiency (e.g., scaly skin, poor growth, poor wound healing).

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020248
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-01-2004
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 65219-539-10 identifies a specific commercial package of 6 bag in 1 case / 1000 ml in 1 bag (65219-539-01) of Intralipid, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This emulsion is formulated for intravenous use and contains soybean oil 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 Fresenius Kabi Usa, Llc on April 01, 2004. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to provide calories to patients who are getting their nutrition through an injection into the vein. Calories are needed to provide the body with energy so that the body can work properly. This product is also used to provide a certain nutrient (essential fatty acids) to people who do not have enough of it. This product helps to prevent or reverse the signs of this deficiency (e.g., scaly skin, poor growth, poor wound healing).

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65219053910. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
65219-539-10
11-Digit CMS (5-4-2)
65219-0539-10

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