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  5. NDC Package Code: 63323-205-00 Omegaven

NDC Package 63323-205-00 Omegaven

Fish Oil Injection, Emulsion Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Omegaven
Non-Proprietary Name:
Fish Oil
Substance Name:
Fish Oil
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)].
11-Digit NDC Billing Format:
63323020500
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Fresenius Kabi Usa, Llc
    Dosage Form:
    Injection, Emulsion - An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • FISH OIL .1 g/mL
    • Sample Package:
    No
    FDA Application Number:
    NDA210589
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-27-2018
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    63323-205-5010 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE (63323-205-21)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63323-205-00?

    The NDC Packaged Code 63323-205-00 is assigned to a 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. The product's dosage form is injection, emulsion and is administered via intravenous form.

    Is NDC 63323-205 included in the NDC Directory?

    Yes, Omegaven with product code 63323-205 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on July 27, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 63323-205-00?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 63323-205-00?

    The 11-digit format is 63323020500. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-263323-205-005-4-263323-0205-00