NDC Package 63323-820-10 Smoflipid

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

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:
63323-820-10
Package Description:
6 BAG in 1 CASE / 1000 mL in 1 BAG (63323-820-05)
Product Code:
Proprietary Name:
Smoflipid
Non-Proprietary Name:
Smoflipid
Substance Name:
Fish Oil; Medium-chain Triglycerides; Olive Oil; Soybean Oil
Usage Information:
Smoflipid is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Limitations of UseThe omega-6: omega-3 fatty acid ratio and Medium Chain Triglycerides in Smoflipid have not been shown to improve clinical outcomes compared to other intravenous lipid emulsions [See Clinical Studies (14)].
11-Digit NDC Billing Format:
63323082010
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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.
  • Sample Package:
    No
    FDA Application Number:
    NDA207648
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-13-2016
    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
    63323-820-0010 BAG in 1 CASE / 100 mL in 1 BAG (63323-820-01)
    63323-820-1220 BAG in 1 CASE / 100 mL in 1 BAG (63323-820-02)
    63323-820-5012 BAG in 1 CASE / 500 mL in 1 BAG (63323-820-03)
    63323-820-7410 BAG in 1 CASE / 250 mL in 1 BAG (63323-820-04)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63323-820-10?

    The NDC Packaged Code 63323-820-10 is assigned to a package of 6 bag in 1 case / 1000 ml in 1 bag (63323-820-05) of Smoflipid, 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 63323-820 included in the NDC Directory?

    Yes, Smoflipid with product code 63323-820 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on July 13, 2016 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 63323-820-10?

    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 63323-820-10?

    The 11-digit format is 63323082010. 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
    5-3-263323-820-105-4-263323-0820-10