Clinimix E Injection
NDC 0338-7028

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0338-7028?
  4. Clinimix E Uses
  5. Active Ingredients
  6. NDC to RxNorm Crosswalk
  7. Pharmacologic Classes
  8. Patient Education

Product Information

Clinimix E (leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose) is a NDA-approved product labeled by Baxter Healthcare Company. This medication is typically used as a amino acid [epc]. It is supplied as a injection for intravenous administration. This product entry covers the primary NDC 0338-7028 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0338-7028
Proprietary Name:
Clinimix E
Non-Proprietary Name: [1]
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose
Substance Name: [2]
Alanine; Arginine; Calcium Chloride; Dextrose; Glycine; Histidine; Isoleucine; Leucine; Lysine; Magnesium Chloride; Methionine; Phenylalanine; Potassium Phosphate, Dibasic; Proline; Serine; Sodium Acetate; Sodium Chloride; 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 - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
Intravenous - Administration within or into a vein or veins.

Labeler & Regulatory Data

Labeler Name: [5]
Baxter Healthcare Company
Labeler Code:
0338
Product Label ID:
8469d6fb-d6ef-476f-8cc3-0905192de0a8
FDA Application Number: [6]
NDA020678
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
07-15-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0338-7028?

The NDC code 0338-7028 is assigned by the FDA to the product Clinimix E. It is commonly known by its generic name, leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose. This pharmaceutical product is labeled by Baxter Healthcare Company and is currently categorized as listed product. The medication is a injection administered via intravenous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0338-7028-04. 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?

CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.

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 880 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 489 mg/100mL - An essential amino acid that is physiologically active in the L-form.
  • CALCIUM CHLORIDE 33 mg/100mL - A salt used to replenish calcium levels, as an acid-producing diuretic, and as an antidote for magnesium poisoning.
  • DEXTROSE 10 g/100mL
  • GLYCINE 438 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 204 mg/100mL - An essential amino acid that is required for the production of HISTAMINE.
  • ISOLEUCINE 255 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 311 mg/100mL - An essential branched-chain amino acid important for hemoglobin formation.
  • LYSINE 247 mg/100mL - An essential amino acid. It is often added to animal feed.
  • MAGNESIUM CHLORIDE 51 mg/100mL - Magnesium chloride. An inorganic compound consisting of one magnesium and two chloride ions. The compound is used in medicine as a source of magnesium ions, which are essential for many cellular activities. It has also been used as a cathartic and in alloys.
  • METHIONINE 170 mg/100mL - A sulfur-containing essential L-amino acid that is important in many body functions.
  • PHENYLALANINE 238 mg/100mL - An essential aromatic amino acid that is a precursor of MELANIN; DOPAMINE; noradrenalin (NOREPINEPHRINE), and THYROXINE.
  • POTASSIUM PHOSPHATE, DIBASIC 261 mg/100mL
  • PROLINE 289 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 213 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.
  • SODIUM ACETATE 297 mg/100mL - The trihydrate sodium salt of acetic acid, which is used as a source of sodium ions in solutions for dialysis and as a systemic and urinary alkalizer, diuretic, and expectorant.
  • SODIUM CHLORIDE 77 mg/100mL - A ubiquitous sodium salt that is commonly used to season food.
  • THREONINE 179 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 77 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 17 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 247 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.

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: 1090635 - alanine 8.8 MG/ML / arginine 4.89 MG/ML / calcium chloride 0.004 MEQ/ML / dibasic potassium phosphate 2.61 MG/ML / glucose 100 MG/ML / glycine 4.38 MG/ML / histidine 2.04 MG/ML / isoleucine 2.55 MG/ML / leucine 3.11 MG/ML / lysine 2.47 MG/ML / magnesium chloride 0.01 MEQ/ML / methionine 1.7 MG/ML / phenylalanine 2.38 MG/ML / proline 2.89 MG/ML / serine 2.13 MG/ML / sodium acetate trihydrate 2.97 MG/ML / sodium chloride 0.013 MEQ/ML / threonine 1.79 MG/ML / tryptophan 0.77 MG/ML / tyrosine 0.17 MG/ML / valine 2.47 MG/ML Injectable Solution
  • RxCUI: 1090635 - Alanine 8.8 MG/ML / Arginine 4.89 MG/ML / Calcium Chloride 0.004 MEQ/ML / Dibasic K+ phosphate 2.61 MG/ML / Glucose 100 MG/ML / Glycine 4.38 MG/ML / Histidine 2.04 MG/ML / Isoleucine 2.55 MG/ML / Leucine 3.11 MG/ML / Lysine 2.47 MG/ML / Magnesium Chloride 0.01 MEQ/ML / Methionine 1.7 MG/ML / Phenylalanine 2.38 MG/ML / Proline 2.89 MG/ML / Serine 2.13 MG/ML / Sodium Acetate Trihydrate 2.97 MG/ML / NaCl 0.013 MEQ/ML / Threonine 1.79 MG/ML / Tryptophan 0.77 MG/ML / Tyrosine 0.17 MG/ML / Valine 2.47 MG/ML Injectable Solution
  • RxCUI: 1090635 - Alanine 8.8 MG/ML / Arginine 4.89 MG/ML / Calcium Chloride 0.004 MEQ/ML / Dibasic Pot phosphate 2.61 MG/ML / Glucose 100 MG/ML / Glycine 4.38 MG/ML / Histidine 2.04 MG/ML / Isoleucine 2.55 MG/ML / Leucine 3.11 MG/ML / Lysine 2.47 MG/ML / Magnesium Chloride 0.01 MEQ/ML / Methionine 1.7 MG/ML / Phenylalanine 2.38 MG/ML / Proline 2.89 MG/ML / Serine 2.13 MG/ML / Sodium Acetate Trihydrate 2.97 MG/ML / NaCl 0.013 MEQ/ML / Threonine 1.79 MG/ML / Tryptophan 0.77 MG/ML / Tyrosine 0.17 MG/ML / Valine 2.47 MG/ML Injectable Solution
  • RxCUI: 1090639 - Clinimix E 4.25/10 Injectable Solution
  • RxCUI: 1090639 - alanine 8.8 MG/ML / arginine 4.89 MG/ML / calcium chloride 0.004 MEQ/ML / dibasic potassium phosphate 2.61 MG/ML / glucose 100 MG/ML / glycine 4.38 MG/ML / histidine 2.04 MG/ML / isoleucine 2.55 MG/ML / leucine 3.11 MG/ML / lysine 2.47 MG/ML / magnesium chloride 0.01 MEQ/ML / methionine 1.7 MG/ML / phenylalanine 2.38 MG/ML / proline 2.89 MG/ML / serine 2.13 MG/ML / sodium acetate trihydrate 2.97 MG/ML / sodium chloride 0.013 MEQ/ML / threonine 1.79 MG/ML / tryptophan 0.77 MG/ML / tyrosine 0.17 MG/ML / valine 2.47 MG/ML Injectable Solution [Clinimix E 4.25/10]

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".