Clinolipid Injection, Emulsion
NDC 0338-9540
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Clinolipid (olive oil and soybean oil) is a NDA-approved product labeled by Baxter Healthcare Corporation. This medication is typically used as a lipid emulsion [epc]. It is supplied as a injection, emulsion for intravenous administration. This product entry covers the primary NDC 0338-9540 and 4 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0338-9540
Proprietary Name:
Clinolipid
Non-Proprietary Name: [1]
Olive Oil And Soybean Oil
Substance Name: [2]
Olive Oil; Soybean Oil
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Injection, Emulsion
- An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally.
Administration Route(s): [4]
Intravenous - Administration within or into a vein or veins.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0338
Product Label ID:
FDA Application Number: [6]
NDA204508
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
01-01-2016
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 0338-9540?
The NDC code 0338-9540 is assigned by the FDA to the product Clinolipid. It is commonly known by its generic name, olive oil and soybean oil. This pharmaceutical product is labeled by Baxter Healthcare Corporation and is currently categorized as listed product. The medication is a injection, emulsion administered via intravenous route. In terms of distribution, this product is available in 4 different package configurations. The associated package NDC(s) include: 0338-9540-05, 0338-9540-06, 0338-9540-07, 0338-9540-08. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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)]
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- OLIVE OIL 16 g/100mL - Oil extracted from fruit of the OLIVE TREE (genus Olea).
- SOYBEAN OIL 4 g/100mL - Oil from soybean or soybean plant.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- OLIVE OIL (UNII: 6UYK2W1W1E)
- OLIVE OIL (UNII: 6UYK2W1W1E) (Active Moiety)
- SOYBEAN OIL (UNII: 241ATL177A)
- SOYBEAN OIL (UNII: 241ATL177A) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
- GLYCERIN (UNII: PDC6A3C0OX)
- SODIUM OLEATE (UNII: 399SL044HN)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- 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]
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
* Please review the full disclaimer at the bottom of this page.
Patient Education
Olive
What is it? Olive (Olea europaea) is a tree with edible fruit, leaves, and seeds. The fruit and leaves are sometimes used as medicine.
Olive leaf might lower blood pressure. Olive fruit might also be able to kill microbes, such as bacteria and fungus.
People use olive for osteoarthritis, rheumatoid arthritis (RA), and many other conditions, but there is no good scientific evidence to support its uses.
Don't confuse olive with olive oil, the oil from olive fruit. These are not the same.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
