Omegaven Injection, Emulsion
NDC Package 63323-205-00

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

Omegaven (fish oil) injection is omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC). This formulation utilizes a injection, emulsion delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-205 and is authorized under FDA application NDA210589.

Identification & Billing

NDC Package Code
63323-205-00
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-DOSE (63323-205-31)
Product Code
63323-205
11-Digit Billing Format
63323020500
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2053499 - fish oil (containg omega-3 fatty acids) 10 % in 50 ML Injection
  • RxCUI: 2053499 - 50 ML fish oil (containing omega-3 acids) 100 MG/ML Injection
  • RxCUI: 2053499 - fish oil (containg omega-3 fatty acids) 10 % per 50 ML Injection
  • RxCUI: 2053499 - fish oil (containg omega-3 fatty acids) 100 MG/ML per 50 ML Injection
  • RxCUI: 2053504 - Omegaven 10 % in 50 ML Injection

Clinical Specifications

Proprietary Name
Omegaven
Non-Proprietary Name
Fish Oil
Substance Name
Fish 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)
FISH OIL .1 g/mL
Usage Information
Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC). Limitations of Use:Omegaven is not indicated for the prevention of PNAC. It has not been demonstrated that Omegaven prevents PNAC in parenteral nutrition (PN)-dependent patients [see Clinical Studies (14)].It has not been demonstrated that the clinical outcomes observed in patients treated with Omegaven are a result of the omega-6:omega-3 fatty acid ratio of the product [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA210589
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-27-2018
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 (63323-205). Click a package code to view its specific billing and regulatory data.

63323-205-50
10 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE (63323-205-21)

* 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 63323-205-00 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 100 ml in 1 vial, single-dose (63323-205-31) of Omegaven, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, emulsion is formulated for intravenous use and contains fish 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 July 27, 2018. The current certification is valid through December 31, 2026.

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: 63323020500. 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)
63323-205-00
11-Digit CMS (5-4-2)
63323-0205-00

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