Kabiven Injection, Emulsion
NDC Package 63323-712-10

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

Kabiven (dextrose, soybean oil, electrolytes, lysine, phenylalanine, leucine, valine, threonine, methionine, isoleucine, tryptophan, alanine, arginine, glycine, proline, histidine, glutamic acid, serine, aspartic acid and tyrosine) injection is kABIVEN® is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.  KABIVEN® may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. This formulation utilizes a injection, emulsion delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-712 and is authorized under FDA application NDA200656.

Identification & Billing

NDC Package Code
63323-712-10
Package Description
1026 mL in 1 BAG
Product Code
63323-712
11-Digit Billing Format
63323071210
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
1026 ML

Clinical Specifications

Proprietary Name
Kabiven
Non-Proprietary Name
Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine
Substance Name
Alanine; Arginine; Aspartic Acid; Calcium Chloride; Dextrose Monohydrate; Glutamic Acid; Glycine; Histidine; Isoleucine; Leucine; Lysine Hydrochloride; Magnesium Sulfate Heptahydrate; Methionine; Phenylalanine; Potassium Chloride; Proline; Serine; Sodium Acetate; Sodium Glycerophosphate Anhydrous; Soybean Oil; Threonine; Tryptophan; Tyrosine; Valine
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
KABIVEN® is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.  KABIVEN® may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. Limitations of Use:KABIVEN® is not recommended for use in pediatric patients under the age of 2 years, including preterm infants because the fixed content of the formulation does not meet the nutritional requirements of this age group [see Warnings and Precautions (5.1)  and  Use in Specific Populations (8.4)].

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA200656
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-25-2014
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 (63323-712). Click a package code to view its specific billing and regulatory data.

63323-712-15
1540 mL in 1 BAG
63323-712-20
2053 mL in 1 BAG
63323-712-25
2566 mL in 1 BAG

* 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 63323-712-10 identifies a specific commercial package of 1026 ml in 1 bag of Kabiven, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 1026 billable units per package. This injection, emulsion is formulated for intravenous use and contains alanine; arginine; aspartic acid; calcium chloride; dextrose monohydrate; glutamic acid; glycine; histidine; isoleucine; leucine; lysine hydrochloride; magnesium sulfate heptahydrate; methionine; phenylalanine; potassium chloride; proline; serine; sodium acetate; sodium glycerophosphate anhydrous; soybean oil; threonine; tryptophan; tyrosine; valine 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 August 25, 2014. 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: 63323071210. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 1026 total billable units per package. 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)
63323-712-10
11-Digit CMS (5-4-2)
63323-0712-10

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