Intralipid Emulsion
NDC Package 0338-0519-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

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 Baxter Healthcare Corporation, this product is identified by NDC 0338-0519 and is authorized under FDA application NDA020248.

Identification & Billing

NDC Package Code
0338-0519-04
Package Description
1000 mL in 1 BAG
Product Code
11-Digit Billing Format
00338051904
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
1000 ML
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.
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
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
Baxter Healthcare Corporation
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0338-0519). Click a package code to view its specific billing and regulatory data.

250 mL in 1 BAG
500 mL in 1 BAG
250 mL in 1 BAG
100 mL in 1 BAG
250 mL in 1 BAG
500 mL in 1 BAG
500 mL in 1 BAG
1000 mL in 1 BAG
100 mL in 1 BAG
100 mL in 1 BAG

* 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 0338-0519-04 identifies a specific commercial package of 1000 ml in 1 bag of Intralipid, a human prescription drug labeled by Baxter Healthcare Corporation. This product is billed per "ML" milliliter and contains an estimated amount of 1000 billable units per package. 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 Baxter Healthcare Corporation 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 Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338051904. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 1000 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 (4-4-2)
0338-0519-04
11-Digit CMS (5-4-2)
00338-0519-04

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