Omeosport Pellet
NDC 17089-075

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 17089-075?
  5. Omeosport Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

Omeosport (.alpha.-ketoglutaric acid - aconitic acid, cis - adenosine triphosphate - alpha lipoic acid - ascorbic acid - asian ginseng - barium cation - beet - cerous oxalate nonahydrate - coenzyme a - cysteine - fumaric acid - lactic acid, dl - magnesium carbonate - malic acid - manganese phosphate, dibasic - pork - pyridoxine hydrochloride - riboflavin - sodium diethyl oxalacetate - sodium pyruvate - succinic acid - sus scrofa adrenal gland - thiamine hydrochloride - sus scrofa embryo -) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Guna Spa. This medication is typically used as a allergens [cs]. It is supplied as a white pellet for oral administration. This product entry covers the primary NDC 17089-075 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
17089-075
Proprietary Name:
Omeosport
Non-Proprietary Name: [1]
.alpha.-ketoglutaric Acid - Aconitic Acid, Cis - Adenosine Triphosphate - Alpha Lipoic Acid - Ascorbic Acid - Asian Ginseng - Barium Cation - Beet - Cerous Oxalate Nonahydrate - Coenzyme A - Cysteine - Fumaric Acid - Lactic Acid, Dl - Magnesium Carbonate - Malic Acid - Manganese Phosphate, Dibasic - Pork - Pyridoxine Hydrochloride - Riboflavin - Sodium Diethyl Oxalacetate - Sodium Pyruvate - Succinic Acid - Sus Scrofa Adrenal Gland - Thiamine Hydrochloride - Sus Scrofa Embryo -
Substance Name: [2]
.alpha.-ketoglutaric Acid; .alpha.-lipoic Acid; Aconitic Acid, (z)-; Adenosine Triphosphate; Ascorbic Acid; Asian Ginseng; Barium Oxalosuccinate; Beet; Cerous Oxalate Nonahydrate; Coenzyme A; Cysteine; Fumaric Acid; Lactic Acid; Magnesium Carbonate; Malic Acid; Manganese Phosphate, Dibasic; Pork; Pyridoxine Hydrochloride; Riboflavin; Sodium Diethyl Oxalacetate; Sodium Pyruvate; Succinic Acid; Sus Scrofa Adrenal Gland; Sus Scrofa Embryo; Thiamine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Guna Spa
Labeler Code:
17089
Product Label ID:
119a205d-0074-48ff-ac78-e2300db45227
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
05-23-2006
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)

Code Structure Chart

Product Details

What is NDC 17089-075?

The NDC code 17089-075 is assigned by the FDA to the product Omeosport. It is commonly known by its generic name, .alpha.-ketoglutaric acid - aconitic acid, cis - adenosine triphosphate - alpha lipoic acid - ascorbic acid - asian ginseng - barium cation - beet - cerous oxalate nonahydrate - coenzyme a - cysteine - fumaric acid - lactic acid, dl - magnesium carbonate - malic acid - manganese phosphate, dibasic - pork - pyridoxine hydrochloride - riboflavin - sodium diethyl oxalacetate - sodium pyruvate - succinic acid - sus scrofa adrenal gland - thiamine hydrochloride - sus scrofa embryo -. This pharmaceutical product is labeled by Guna Spa and is currently categorized as listed product. The medication is a pellet administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 17089-075-20. 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?

Take 15 minutes before mealsAdults and children 12 years and older    5 pellets 3 times per dayChildren between 12 years and 6 years of age   3 pellets 3 times per dayChildren under 6 years     1 pellet 3 times per day to be dissolved into a little water

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.
  • .ALPHA.-KETOGLUTARIC ACID 6 [hp_X]/4g - A family of compounds containing an oxo group with the general structure of 1,5-pentanedioic acid. (From Lehninger, Principles of Biochemistry, 1982, p442)
  • .ALPHA.-LIPOIC ACID 6 [hp_X]/4g - An octanoic acid bridged with two sulfurs so that it is sometimes also called a pentanoic acid in some naming schemes. It is biosynthesized by cleavage of LINOLEIC ACID and is a coenzyme of oxoglutarate dehydrogenase (KETOGLUTARATE DEHYDROGENASE COMPLEX). It is used in DIETARY SUPPLEMENTS.
  • ACONITIC ACID, (Z)- 6 [hp_X]/4g
  • ADENOSINE TRIPHOSPHATE 8 [hp_X]/4g - An adenine nucleotide containing three phosphate groups esterified to the sugar moiety. In addition to its crucial roles in metabolism adenosine triphosphate is a neurotransmitter.
  • ASCORBIC ACID 4 [hp_X]/4g - A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.
  • ASIAN GINSENG 3 [hp_X]/4g
  • BARIUM OXALOSUCCINATE 6 [hp_X]/4g
  • BEET 2 [hp_X]/4g - A species of the Beta genus. Cultivars are used as a source of beets (root) or chard (leaves).
  • CEROUS OXALATE NONAHYDRATE 6 [hp_X]/4g
  • COENZYME A 6 [hp_X]/4g - Venoms from jellyfish; CORALS; SEA ANEMONES; etc. They contain hemo-, cardio-, dermo- , and neuro-toxic substances and probably ENZYMES. They include palytoxin, sarcophine, and anthopleurine.
  • CYSTEINE 6 [hp_X]/4g - A thiol-containing non-essential amino acid that is oxidized to form CYSTINE.
  • FUMARIC ACID 6 [hp_X]/4g - see also record for ferrous fumarate; use FUMARATES for general fumaric acid esters
  • LACTIC ACID 8 [hp_X]/4g - A normal intermediate in the fermentation (oxidation, metabolism) of sugar. The concentrated form is used internally to prevent gastrointestinal fermentation. (From Stedman, 26th ed)
  • MAGNESIUM CARBONATE 2 [hp_X]/4g - RN given refers to parent cpd (1:1)
  • MALIC ACID 6 [hp_X]/4g
  • MANGANESE PHOSPHATE, DIBASIC 6 [hp_X]/4g
  • PORK 6 [hp_X]/4g - MEAT or flesh of a pig (Sus scrofa) used as food.
  • PYRIDOXINE HYDROCHLORIDE 6 [hp_X]/4g - The 4-methanol form of VITAMIN B 6 which is converted to PYRIDOXAL PHOSPHATE which is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. Although pyridoxine and Vitamin B 6 are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading (EE Snell; Ann NY Acad Sci, vol 585 pg 1, 1990).
  • RIBOFLAVIN 6 [hp_X]/4g - Nutritional factor found in milk, eggs, malted barley, liver, kidney, heart, and leafy vegetables. The richest natural source is yeast. It occurs in the free form only in the retina of the eye, in whey, and in urine; its principal forms in tissues and cells are as FLAVIN MONONUCLEOTIDE and FLAVIN-ADENINE DINUCLEOTIDE.
  • SODIUM DIETHYL OXALACETATE 6 [hp_X]/4g
  • SODIUM PYRUVATE 6 [hp_X]/4g
  • SUCCINIC ACID 6 [hp_X]/4g - A water-soluble, colorless crystal with an acid taste that is used as a chemical intermediate, in medicine, the manufacture of lacquers, and to make perfume esters. It is also used in foods as a sequestrant, buffer, and a neutralizing agent. (Hawley's Condensed Chemical Dictionary, 12th ed, p1099; McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed, p1851)
  • SUS SCROFA ADRENAL GLAND 10 [hp_X]/4g
  • SUS SCROFA EMBRYO 6 [hp_X]/4g
  • THIAMINE HYDROCHLORIDE 4 [hp_X]/4g

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:

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 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".