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  4. NDC Product Code: 63323-820 Smoflipid

NDC 63323-820 Smoflipid

Injection, Emulsion Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 63323-820?
  4. Smoflipid Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
63323-820
Proprietary Name:
Smoflipid
Non-Proprietary Name: [1]
Smoflipid
Substance Name: [2]
Fish Oil; Medium-chain Triglycerides; Olive Oil; Soybean Oil
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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 Name: [5]
    Fresenius Kabi Usa, Llc
    Labeler Code:
    63323
    Product Label ID:
    e0e9d917-ff6f-488e-a6a8-0ad59dd17d80
    FDA Application Number: [6]
    NDA207648
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    07-13-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 63323-820-00

    Package Description: 10 BAG in 1 CASE / 100 mL in 1 BAG (63323-820-01)

    NDC Code 63323-820-10

    Package Description: 6 BAG in 1 CASE / 1000 mL in 1 BAG (63323-820-05)

    NDC Code 63323-820-12

    Package Description: 20 BAG in 1 CASE / 100 mL in 1 BAG (63323-820-02)

    NDC Code 63323-820-50

    Package Description: 12 BAG in 1 CASE / 500 mL in 1 BAG (63323-820-03)

    NDC Code 63323-820-74

    Package Description: 10 BAG in 1 CASE / 250 mL in 1 BAG (63323-820-04)

    Product Details

    What is NDC 63323-820?

    The NDC code 63323-820 is assigned by the FDA to the product Smoflipid which is a human prescription drug product labeled by Fresenius Kabi Usa, Llc. The product's dosage form is injection, emulsion and is administered via intravenous form. The product is distributed in 5 packages with assigned NDC codes 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), 63323-820-50 12 bag in 1 case / 500 ml in 1 bag (63323-820-03), 63323-820-74 10 bag in 1 case / 250 ml in 1 bag (63323-820-04). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Smoflipid?

    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)].

    What are Smoflipid Active Ingredients?

    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.

    Which are Smoflipid UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Smoflipid Inactive Ingredients 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:

    Which are the Pharmacologic Classes for Smoflipid?

    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 disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".