Smoflipid Injection, Emulsion
NDC Package 63323-820-50

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

Smoflipid injection is 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. This formulation utilizes a injection, emulsion delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-820 and is authorized under FDA application NDA207648.

Identification & Billing

NDC Package Code
63323-820-50
Package Description
12 BAG in 1 CASE / 500 mL in 1 BAG (63323-820-03)
Product Code
63323-820
11-Digit Billing Format
63323082050

Clinical Specifications

Proprietary Name
Smoflipid
Non-Proprietary Name
Smoflipid
Substance Name
Fish Oil; Medium-chain Triglycerides; 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
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)].

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA207648
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-13-2016
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 (63323-820). Click a package code to view its specific billing and regulatory data.

63323-820-00
10 BAG in 1 CASE / 100 mL in 1 BAG (63323-820-01)
63323-820-10
6 BAG in 1 CASE / 1000 mL in 1 BAG (63323-820-05)
63323-820-12
20 BAG in 1 CASE / 100 mL in 1 BAG (63323-820-02)
63323-820-74
10 BAG in 1 CASE / 250 mL in 1 BAG (63323-820-04)

* 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 63323-820-50 identifies a specific commercial package of 12 bag in 1 case / 500 ml in 1 bag (63323-820-03) of Smoflipid, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, emulsion is formulated for intravenous use and contains fish oil; medium-chain triglycerides; 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 Fresenius Kabi Usa, Llc on July 13, 2016. 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: 63323082050. 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)
63323-820-50
11-Digit CMS (5-4-2)
63323-0820-50

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