Clinolipid Injection, Emulsion
NDC Package 0338-9540-07

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

Clinolipid (olive oil and soybean oil) injection is cLINOLIPID is indicated in adults for providing a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.Limitations of Use CLINOLIPID is not indicated for use in pediatric patients because there is insufficient data to demonstrate that CLINOLIPID provides sufficient amounts of essential fatty acids in this population. This formulation utilizes a injection, emulsion delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-9540 and is authorized under FDA application NDA204508.

Identification & Billing

NDC Package Code
0338-9540-07
Package Description
12 BAG in 1 CARTON / 500 mL in 1 BAG (0338-9540-03)
Product Code
0338-9540
11-Digit Billing Format
00338954007
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1986373 - olive oil 16 % / soybean oil 4 % in 1000 mL Injection
  • RxCUI: 1986373 - 1000 ML olive oil 160 MG/ML / soybean oil 40 MG/ML Injection
  • RxCUI: 1986373 - olive oil 16 % / soybean oil 4 % per 1000 ML Injection
  • RxCUI: 1986378 - Clinolipid 20 % in 1000 mL Injection
  • RxCUI: 1986378 - 1000 ML olive oil 160 MG/ML / soybean oil 40 MG/ML Injection [Clinolipid]

Clinical Specifications

Proprietary Name
Clinolipid
Non-Proprietary Name
Olive Oil And Soybean Oil
Substance Name
Olive Oil; Soybean Oil
Dosage Form
Injection, Emulsion - An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
CLINOLIPID is indicated in adults for providing a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.Limitations of Use CLINOLIPID is not indicated for use in pediatric patients because there is insufficient data to demonstrate that CLINOLIPID provides sufficient amounts of essential fatty acids in this population. [See Use in Specific Populations (8.4)]The omega-3: omega-6 fatty acid ratio in CLINOLIPID has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions. [See Clinical Studies (14)]

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA204508
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-01-2016
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 (0338-9540). Click a package code to view its specific billing and regulatory data.

0338-9540-05
15 BAG in 1 CARTON / 100 mL in 1 BAG (0338-9540-01)
0338-9540-06
10 BAG in 1 CARTON / 250 mL in 1 BAG (0338-9540-02)
0338-9540-08
6 BAG in 1 CARTON / 1000 mL in 1 BAG (0338-9540-04)

* 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 0338-9540-07 identifies a specific commercial package of 12 bag in 1 carton / 500 ml in 1 bag (0338-9540-03) of Clinolipid, a human prescription drug labeled by Baxter Healthcare Corporation. This injection, emulsion is formulated for intravenous use and contains olive oil; 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 January 01, 2016. The current certification is valid through December 31, 2027.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338954007. 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 (4-4-2)
0338-9540-07
11-Digit CMS (5-4-2)
00338-9540-07

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