Clinisol Injection, Solution
NDC 0338-0502

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0338-0502?
  4. Clinisol 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

Clinisol (lysine, leucine, phenylalanine, valine, histidine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, proline, glutamic acid, serine, aspartic acid, tyrosine) is a ANDA-approved product labeled by Baxter Healthcare Corporation. 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 0338-0502 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0338-0502
Proprietary Name:
Clinisol
Non-Proprietary Name: [1]
Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine
Substance Name: [2]
Alanine; Arginine; Aspartic Acid; Glutamic Acid; Glycine; Histidine; Isoleucine; Leucine; Lysine Acetate; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; 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]
Baxter Healthcare Corporation
Labeler Code:
0338
Product Label ID:
65ffc962-7538-41ea-9afb-4af5fbce4c5b
FDA Application Number: [6]
ANDA020512
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
08-30-1996
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0338-0502?

The NDC code 0338-0502 is assigned by the FDA to the product Clinisol. It is commonly known by its generic name, lysine, leucine, phenylalanine, valine, histidine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, proline, glutamic acid, serine, aspartic acid, tyrosine. This pharmaceutical product is labeled by Baxter Healthcare Corporation 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 2 different package configurations. The associated package NDC(s) include: 0338-0502-03, 0338-0502-06. 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?

15% CLINISOL - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.

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.
  • ALANINE 2.17 g/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 1.47 g/100mL - An essential amino acid that is physiologically active in the L-form.
  • ASPARTIC ACID 434 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 749 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 1.04 g/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 894 mg/100mL - An essential amino acid that is required for the production of HISTAMINE.
  • ISOLEUCINE 749 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 1.04 g/100mL - An essential branched-chain amino acid important for hemoglobin formation.
  • LYSINE ACETATE 1.18 g/100mL - An essential amino acid. It is often added to animal feed.
  • METHIONINE 749 mg/100mL - A sulfur-containing essential L-amino acid that is important in many body functions.
  • PHENYLALANINE 1.04 g/100mL - An essential aromatic amino acid that is a precursor of MELANIN; DOPAMINE; noradrenalin (NOREPINEPHRINE), and THYROXINE.
  • PROLINE 894 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 592 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 749 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 250 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.
  • TYROSINE 39 mg/100mL - A non-essential amino acid. In animals it is synthesized from PHENYLALANINE. It is also the precursor of EPINEPHRINE; THYROID HORMONES; and melanin.
  • VALINE 960 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: 800584 - alanine 21.7 MG/ML / arginine 14.7 MG/ML / aspartate 4.34 MG/ML / glutamate 7.49 MG/ML / glycine 10.4 MG/ML / histidine 8.94 MG/ML / isoleucine 7.49 MG/ML / leucine 10.4 MG/ML / lysine 11.8 MG/ML / methionine 7.49 MG/ML / phenylalanine 10.4 MG/ML / proline 8.94 MG/ML / serine 5.92 MG/ML / threonine 7.49 MG/ML / tryptophan 2.5 MG/ML / tyrosine 0.39 MG/ML / valine 9.6 MG/ML Injectable Solution
  • RxCUI: 800588 - Clinisol 15 % Injectable Solution
  • RxCUI: 800588 - alanine 21.7 MG/ML / arginine 14.7 MG/ML / aspartate 4.34 MG/ML / glutamate 7.49 MG/ML / glycine 10.4 MG/ML / histidine 8.94 MG/ML / isoleucine 7.49 MG/ML / leucine 10.4 MG/ML / lysine 11.8 MG/ML / methionine 7.49 MG/ML / phenylalanine 10.4 MG/ML / proline 8.94 MG/ML / serine 5.92 MG/ML / threonine 7.49 MG/ML / tryptophan 2.5 MG/ML / tyrosine 0.39 MG/ML / valine 9.6 MG/ML Injectable Solution [Clinisol 15]
  • RxCUI: 800588 - Clinisol 15 % Amino Acids 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.

* Please review the full disclaimer at the bottom of this page.

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".