NDC 51495-205 Amino Acid Mixture Blend Pmcb - Pediatric Blend

Powder - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.
NDC Product Code:
51495-205
Proprietary Name:
Amino Acid Mixture Blend Pmcb - Pediatric Blend
Non-Proprietary Name: [1]
Amino Acid Mixture Blend Pmcb - Pediatric Blend
Substance Name: [2]
Alanine; Arginine; Aspartic Acid; Cysteine; Glutamic Acid; Glycine; Histidine; Isoleucine; Leucine; Lysine Hydrochloride; Methionine; Ornithine Hydrochloride; Phenylalanine; Proline; Serine; Taurine; Threonine; Tryptophan; Tyrosine; Valine
NDC Directory Status:
Drug For Further Processing
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Labeler Name: [5]
Ajinomoto Health & Nutrition North America Inc.
Labeler Code:
51495
Marketing Category: [8]
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date: [9]
10-01-2022
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Navigator:

Product Packages

NDC Code 51495-205-02

Package Description: 25 kg in 1 DRUM

Product Details

What is NDC 51495-205?

The NDC code 51495-205 is assigned by the FDA to the UNFINISHED product Amino Acid Mixture Blend Pmcb - Pediatric Blend which is drug for further processing product labeled by Ajinomoto Health & Nutrition North America Inc.. The generic name of Amino Acid Mixture Blend Pmcb - Pediatric Blend is amino acid mixture blend pmcb - pediatric blend. The product's dosage form is powder. The product is distributed in a single package with assigned NDC code 51495-205-02 25 kg in 1 drum . 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 Amino Acid Mixture Blend Pmcb - Pediatric Blend 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.
  • ALANINE 7.8 kg/100kg - 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 8.2 kg/100kg - An essential amino acid that is physiologically active in the L-form.
  • ASPARTIC ACID 5.85 kg/100kg - 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.
  • CYSTEINE 1.85 kg/100kg - A thiol-containing non-essential amino acid that is oxidized to form CYSTINE.
  • GLUTAMIC ACID 9.75 kg/100kg - 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 3.92 kg/100kg - 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 3.72 kg/100kg - An essential amino acid that is required for the production of HISTAMINE.
  • ISOLEUCINE 6.5 kg/100kg - 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 9.75 kg/100kg - An essential branched-chain amino acid important for hemoglobin formation.
  • LYSINE HYDROCHLORIDE 12.05 kg/100kg - An essential amino acid. It is often added to animal feed.
  • METHIONINE 2.35 kg/100kg - A sulfur-containing essential L-amino acid that is important in many body functions.
  • ORNITHINE HYDROCHLORIDE 3.1 kg/100kg
  • PHENYLALANINE 4.12 kg/100kg - An essential aromatic amino acid that is a precursor of MELANIN; DOPAMINE; noradrenalin (NOREPINEPHRINE), and THYROXINE.
  • PROLINE 2.94 kg/100kg - 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 3.92 kg/100kg - 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.
  • TAURINE .59 kg/100kg - A conditionally essential nutrient, important during mammalian development. It is present in milk but is isolated mostly from ox bile and strongly conjugates bile acids.
  • THREONINE 3.62 kg/100kg - 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 1.97 kg/100kg - 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 .76 kg/100kg - A non-essential amino acid. In animals it is synthesized from PHENYLALANINE. It is also the precursor of EPINEPHRINE; THYROID HORMONES; and melanin.
  • VALINE 7.4 kg/100kg - 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.

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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.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[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".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.