Clinimix Injection
NDC 0338-7015

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0338-7015?
  4. Clinimix Uses
  5. Active Ingredients
  6. NDC to RxNorm Crosswalk
  7. Pharmacologic Classes

Product Information

Clinimix (leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose) is a NDA-approved product labeled by Baxter Healthcare Corporation. 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 0338-7015 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0338-7015
Proprietary Name:
Clinimix
Non-Proprietary Name: [1]
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose
Substance Name: [2]
Alanine; Arginine; Dextrose; Glycine; Histidine; Isoleucine; Leucine; Lysine; 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 - 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 Corporation
Labeler Code:
0338
Product Label ID:
dccff103-8695-400c-a15d-cc2fd078760a
FDA Application Number: [6]
NDA020734
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 0338-7015?

The NDC code 0338-7015 is assigned by the FDA to the product Clinimix. It is commonly known by its generic name, leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose. This pharmaceutical product is labeled by Baxter Healthcare Corporation 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: 0338-7015-04. 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 is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX 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 1035 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 575 mg/100mL - An essential amino acid that is physiologically active in the L-form.
  • DEXTROSE 20 g/100mL
  • GLYCINE 515 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 240 mg/100mL - An essential amino acid that is required for the production of HISTAMINE.
  • ISOLEUCINE 300 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 365 mg/100mL - An essential branched-chain amino acid important for hemoglobin formation.
  • LYSINE 290 mg/100mL - An essential amino acid. It is often added to animal feed.
  • METHIONINE 200 mg/100mL - A sulfur-containing essential L-amino acid that is important in many body functions.
  • PHENYLALANINE 280 mg/100mL - An essential aromatic amino acid that is a precursor of MELANIN; DOPAMINE; noradrenalin (NOREPINEPHRINE), and THYROXINE.
  • PROLINE 340 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 250 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 210 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 90 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 20 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 290 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: 800401 - alanine 8.8 MG/ML / arginine 4.89 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 / methionine 1.7 MG/ML / phenylalanine 2.38 MG/ML / proline 2.89 MG/ML / serine 2.13 MG/ML / threonine 1.79 MG/ML / tryptophan 0.77 MG/ML / tyrosine 0.17 MG/ML / valine 2.47 MG/ML Injectable Solution
  • RxCUI: 800405 - Clinimix 4.25/10 Injectable Solution
  • RxCUI: 800405 - alanine 8.8 MG/ML / arginine 4.89 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 / methionine 1.7 MG/ML / phenylalanine 2.38 MG/ML / proline 2.89 MG/ML / serine 2.13 MG/ML / threonine 1.79 MG/ML / tryptophan 0.77 MG/ML / tyrosine 0.17 MG/ML / valine 2.47 MG/ML Injectable Solution [Clinimix 4.25/10]
  • RxCUI: 800405 - Clinimix 4.25/10 (4.25 % amino acids in dextrose 10 % ) Injectable Solution
  • RxCUI: 800416 - alanine 8.8 MG/ML / arginine 4.89 MG/ML / glucose 50 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 / methionine 1.7 MG/ML / phenylalanine 2.38 MG/ML / proline 2.89 MG/ML / serine 2.13 MG/ML / threonine 1.79 MG/ML / tryptophan 0.77 MG/ML / tyrosine 0.17 MG/ML / valine 2.47 MG/ML 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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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".