Aminosyn Ii Injection, Solution
NDC 0990-7172

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0990-7172?
  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

Aminosyn Ii (isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine) is a NDA-approved product labeled by Icu Medical Inc.. This medication is typically used as a amino acid [epc]. It is supplied as a injection, solution for intravenous administration. This product entry covers the primary NDC 0990-7172 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0990-7172
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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Icu Medical Inc.
Labeler Code:
0990
Product Label ID:
5b426208-f090-4650-86c3-89040ba45c2d
FDA Application Number: [6]
NDA020015
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
11-01-2019
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0990-7172?

The NDC code 0990-7172 is assigned by the FDA to the product Aminosyn Ii. It is commonly known by its generic name, isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine. This pharmaceutical product is labeled by Icu Medical Inc. and is currently categorized as listed product. The medication is a injection, solution administered via intravenous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0990-7172-17. 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?

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 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.
  • ACETYL L-TYROSINE 270 mg/100mL
  • ALANINE 993 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 1018 mg/100mL - An essential amino acid that is physiologically active in the L-form.
  • ASPARTIC ACID 700 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 738 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 500 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 300 mg/100mL - An essential amino acid that is required for the production of HISTAMINE.
  • ISOLEUCINE 660 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 1000 mg/100mL - An essential branched-chain amino acid important for hemoglobin formation.
  • LYSINE ACETATE 1050 mg/100mL - An essential amino acid. It is often added to animal feed.
  • METHIONINE 172 mg/100mL - A sulfur-containing essential L-amino acid that is important in many body functions.
  • PHENYLALANINE 298 mg/100mL - An essential aromatic amino acid that is a precursor of MELANIN; DOPAMINE; noradrenalin (NOREPINEPHRINE), and THYROXINE.
  • PROLINE 722 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 530 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 400 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 200 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 500 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 the associated UNII Codes?

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

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:

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: 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 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.

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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 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".