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  5. NDC Package Code: 0338-9540-06 Clinolipid

NDC Package 0338-9540-06 Clinolipid

Olive Oil And Soybean 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:
0338-9540-06
Package Description:
10 BAG in 1 CARTON / 250 mL in 1 BAG (0338-9540-02)
Product Code:
0338-9540
Proprietary Name:
Clinolipid
Non-Proprietary Name:
Olive Oil And Soybean Oil
Substance Name:
Olive Oil; Soybean Oil
Usage Information:
CLINOLIPID is indicated in adults for providing a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.Limitations of Use CLINOLIPID is not indicated for use in pediatric patients because there is insufficient data to demonstrate that CLINOLIPID provides sufficient amounts of essential fatty acids in this population. [See Use in Specific Populations (8.4)]The omega-3: omega-6 fatty acid ratio in CLINOLIPID has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions. [See Clinical Studies (14)]
11-Digit NDC Billing Format:
00338954006
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1986373 - olive oil 16 % / soybean oil 4 % in 1000 mL Injection
  • RxCUI: 1986373 - 1000 ML olive oil 160 MG/ML / soybean oil 40 MG/ML Injection
  • RxCUI: 1986373 - olive oil 16 % / soybean oil 4 % per 1000 ML Injection
  • RxCUI: 1986378 - Clinolipid 20 % in 1000 mL Injection
  • RxCUI: 1986378 - 1000 ML olive oil 160 MG/ML / soybean oil 40 MG/ML Injection [Clinolipid]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Baxter Healthcare Corporation
    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):
  • OLIVE OIL 16 g/100mL
  • SOYBEAN OIL 4 g/100mL
    • Pharmacologic Class(es):
  • Lipid Emulsion - [EPC] (Established Pharmacologic Class)
  • Lipid Emulsion - [EPC] (Established Pharmacologic Class)
  • Lipids - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA204508
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-01-2016
    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
    0338-9540-0515 BAG in 1 CARTON / 100 mL in 1 BAG (0338-9540-01)
    0338-9540-0712 BAG in 1 CARTON / 500 mL in 1 BAG (0338-9540-03)
    0338-9540-086 BAG in 1 CARTON / 1000 mL in 1 BAG (0338-9540-04)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0338-9540-06?

    The NDC Packaged Code 0338-9540-06 is assigned to a package of 10 bag in 1 carton / 250 ml in 1 bag (0338-9540-02) of Clinolipid, a human prescription drug labeled by Baxter Healthcare Corporation. The product's dosage form is injection, emulsion and is administered via intravenous form.

    Is NDC 0338-9540 included in the NDC Directory?

    Yes, Clinolipid with product code 0338-9540 is active and included in the NDC Directory. The product was first marketed by Baxter Healthcare Corporation on January 01, 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 0338-9540-06?

    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 0338-9540-06?

    The 11-digit format is 00338954006. 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 4-4-2 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
    4-4-20338-9540-065-4-200338-9540-06