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  4. NDC Product Code: 0990-7171 Aminosyn Ii

NDC 0990-7171 Aminosyn Ii

Isoleucine,Leucine,Lysine - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0990-7171?
  4. Aminosyn Ii Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

NDC Product Code:
0990-7171
Proprietary Name:
Aminosyn Ii
Non-Proprietary Name: [1]
Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyltyrosine, And Glycine
Substance Name: [2]
Acetyl L-tyrosine; Alanine; Arginine; Aspartic Acid; Glutamic Acid; Glycine; Histidine; Isoleucine; Leucine; Lysine Acetate; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Valine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Icu Medical Inc.
    Labeler Code:
    0990
    Product Label ID:
    5b426208-f090-4650-86c3-89040ba45c2d
    FDA Application Number: [6]
    NDA020041
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    11-01-2019
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 0990-7171?

    The NDC code 0990-7171 is assigned by the FDA to the product Aminosyn Ii which is a human prescription drug product labeled by Icu Medical Inc.. The generic name of Aminosyn Ii is isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine. The product's dosage form is injection, solution and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 0990-7171-17 6 pouch in 1 case / 1 bag in 1 pouch / 2000 ml in 1 bag. 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 Aminosyn Ii?

    Aminosyn II, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate. SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION OF THE ATTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN II SOLUTIONS WITHOUT ELECTROLYTES. Aminosyn II can be administered peripherally with dilute (5 to 10%) dextrose solution and I.V. fat emulsion as a source of nutritional support. This form of nutritional support can help to preserve protein and reduce catabolism in stress conditions where oral intake is inadequate. Aminosyn II is also indicated for central vein infusion to prevent or reverse negative nitrogen balance in patients where the alimentary tract, by the oral, gastrostomy or jejunostomy route cannot or should not be used and gastrointestinal absorption of protein is impaired.

    What are Aminosyn Ii 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.
    • ACETYL L-TYROSINE 405 mg/100mL
    • ALANINE 1490 mg/100mL - A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.
    • ARGININE 1527 mg/100mL - An essential amino acid that is physiologically active in the L-form.
    • ASPARTIC ACID 1050 mg/100mL - One of the non-essential amino acids commonly occurring in the L-form. It is found in animals and plants, especially in sugar cane and sugar beets. It may be a neurotransmitter.
    • GLUTAMIC ACID 1107 mg/100mL - A non-essential amino acid naturally occurring in the L-form. Glutamic acid is the most common excitatory neurotransmitter in the CENTRAL NERVOUS SYSTEM.
    • GLYCINE 750 mg/100mL - A non-essential amino acid. It is found primarily in gelatin and silk fibroin and used therapeutically as a nutrient. It is also a fast inhibitory neurotransmitter.
    • HISTIDINE 450 mg/100mL - An essential amino acid that is required for the production of HISTAMINE.
    • ISOLEUCINE 990 mg/100mL - An essential branched-chain aliphatic amino acid found in many proteins. It is an isomer of LEUCINE. It is important in hemoglobin synthesis and regulation of blood sugar and energy levels.
    • LEUCINE 1500 mg/100mL - An essential branched-chain amino acid important for hemoglobin formation.
    • LYSINE ACETATE 1575 mg/100mL - An essential amino acid. It is often added to animal feed.
    • METHIONINE 258 mg/100mL - A sulfur-containing essential L-amino acid that is important in many body functions.
    • PHENYLALANINE 447 mg/100mL - An essential aromatic amino acid that is a precursor of MELANIN; DOPAMINE; noradrenalin (NOREPINEPHRINE), and THYROXINE.
    • PROLINE 1083 mg/100mL - A non-essential amino acid that is synthesized from GLUTAMIC ACID. It is an essential component of COLLAGEN and is important for proper functioning of joints and tendons.
    • SERINE 795 mg/100mL - A non-essential amino acid occurring in natural form as the L-isomer. It is synthesized from GLYCINE or THREONINE. It is involved in the biosynthesis of PURINES; PYRIMIDINES; and other amino acids.
    • THREONINE 600 mg/100mL - An essential amino acid occurring naturally in the L-form, which is the active form. It is found in eggs, milk, gelatin, and other proteins.
    • TRYPTOPHAN 300 mg/100mL - An essential amino acid that is necessary for normal growth in infants and for NITROGEN balance in adults. It is a precursor of INDOLE ALKALOIDS in plants. It is a precursor of SEROTONIN (hence its use as an antidepressant and sleep aid). It can be a precursor to NIACIN, albeit inefficiently, in mammals.
    • VALINE 750 mg/100mL - A branched-chain essential amino acid that has stimulant activity. It promotes muscle growth and tissue repair. It is a precursor in the penicillin biosynthetic pathway.

    Which are Aminosyn Ii UNII Codes?

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

    Which are Aminosyn Ii 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:

    What is the NDC to RxNorm Crosswalk for Aminosyn Ii?

    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: 800188 - alanine 14.9 MG/ML / arginine 15.3 MG/ML / aspartate 10.5 MG/ML / glutamate 11.1 MG/ML / glycine 7.5 MG/ML / histidine 4.5 MG/ML / isoleucine 9.9 MG/ML / leucine 15 MG/ML / lysine 15.8 MG/ML / methionine 2.58 MG/ML / phenylalanine 4.47 MG/ML / proline 10.8 MG/ML / serine 7.95 MG/ML / threonine 6 MG/ML / tryptophan 3 MG/ML / tyrosine 4.05 MG/ML / valine 7.5 MG/ML Injectable Solution
    • RxCUI: 800192 - Aminosyn II 15 % Injectable Solution
    • RxCUI: 800192 - alanine 14.9 MG/ML / arginine 15.3 MG/ML / aspartate 10.5 MG/ML / glutamate 11.1 MG/ML / glycine 7.5 MG/ML / histidine 4.5 MG/ML / isoleucine 9.9 MG/ML / leucine 15 MG/ML / lysine 15.8 MG/ML / methionine 2.58 MG/ML / phenylalanine 4.47 MG/ML / proline 10.8 MG/ML / serine 7.95 MG/ML / threonine 6 MG/ML / tryptophan 3 MG/ML / tyrosine 4.05 MG/ML / valine 7.5 MG/ML Injectable Solution [Aminosyn II 15%]
    • RxCUI: 800237 - alanine 9.93 MG/ML / arginine 10.2 MG/ML / aspartate 7 MG/ML / glutamate 7.38 MG/ML / glycine 5 MG/ML / histidine 3 MG/ML / isoleucine 6.6 MG/ML / leucine 10 MG/ML / lysine 10.5 MG/ML / methionine 1.72 MG/ML / phenylalanine 2.98 MG/ML / proline 7.22 MG/ML / serine 5.3 MG/ML / threonine 4 MG/ML / tryptophan 2 MG/ML / tyrosine 2.7 MG/ML / valine 5 MG/ML Injectable Solution
    • RxCUI: 800241 - Aminosyn II 10 % Injectable Solution

    Which are the Pharmacologic Classes for Aminosyn Ii?

    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.

    Patient Education

    L-Tryptophan


    What is it? L-Tryptophan is an essential amino acid that is necessary for making proteins. It is naturally found in red meat, poultry, eggs, and dairy.

    L-tryptophan is important for many organs in the body. L-tryptophan is not made by the body and must be consumed from the diet. After absorbing L-tryptophan from food, the body converts some of it to 5-HTP and then to serotonin. Serotonin is a hormone that transmits signals between nerve cells. Changes in serotonin levels in the brain can affect mood.

    People use L-tryptophan for severe PMS symptoms, depression, insomnia, and many other conditions, but there is no good scientific evidence to support any of these uses.


    [Learn More]


    * 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".