Osteobios Solution/ Drops
NDC 17089-259

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 17089-259?
  4. Osteobios Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Osteobios (calcitonin human - calcium carbonate - calcium fluoride - calcium phosphate - isoleucine - leucine - lysine - methionine - phenylalanine - sus scrofa bone - sus scrofa parathyroid gland - threonine - tryptophan - valine -) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Guna Spa. This medication is typically used as a blood coagulation factor [epc]. It is supplied as a solution/ drops for oral administration. This product entry covers the primary NDC 17089-259 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
17089-259
Proprietary Name:
Osteobios
Non-Proprietary Name: [1]
Calcitonin Human - Calcium Carbonate - Calcium Fluoride - Calcium Phosphate - Isoleucine - Leucine - Lysine - Methionine - Phenylalanine - Sus Scrofa Bone - Sus Scrofa Parathyroid Gland - Threonine - Tryptophan - Valine -
Substance Name: [2]
Calcitonin Human; Calcium Carbonate; Calcium Fluoride; Calcium Phosphate; Isoleucine; Leucine; Lysine; Methionine; Phenylalanine; Sus Scrofa Bone; Sus Scrofa Parathyroid Gland; Threonine; Tryptophan; Valine
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
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:
1b8c8c83-1a46-4c0a-b883-e7dce781c5d1
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

Code Structure Chart

Product Details

What is NDC 17089-259?

The NDC code 17089-259 is assigned by the FDA to the product Osteobios. It is commonly known by its generic name, calcitonin human - calcium carbonate - calcium fluoride - calcium phosphate - isoleucine - leucine - lysine - methionine - phenylalanine - sus scrofa bone - sus scrofa parathyroid gland - threonine - tryptophan - valine -. This pharmaceutical product is labeled by Guna Spa and is currently categorized as listed product. The medication is a solution/ drops administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 17089-259-18. 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    20 drops in a little water, 2 times per dayChildren  between 12 years and 6 years of age    10 drops in a little water, 2 times per dayChildren under 6 years     5 drops in a glass of water, 2 times per day

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.
  • CALCITONIN HUMAN 6 [hp_X]/30mL
  • CALCIUM CARBONATE 30 [hp_X]/30mL - Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
  • CALCIUM FLUORIDE 30 [hp_X]/30mL - Calcium fluoride. Occurring in nature as the mineral fluorite or fluorspar. It is the primary source of fluorine and its compounds. Pure calcium fluoride is used as a catalyst in dehydration and dehydrogenation and is used to fluoridate drinking water. (From Merck Index, 11th ed)
  • CALCIUM PHOSPHATE 30 [hp_X]/30mL - Calcium salts of phosphoric acid. These compounds are frequently used as calcium supplements.
  • ISOLEUCINE 3 [hp_X]/30mL - 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 3 [hp_X]/30mL - An essential branched-chain amino acid important for hemoglobin formation.
  • LYSINE 3 [hp_X]/30mL - An essential amino acid. It is often added to animal feed.
  • METHIONINE 3 [hp_X]/30mL - A sulfur-containing essential L-amino acid that is important in many body functions.
  • PHENYLALANINE 3 [hp_X]/30mL - An essential aromatic amino acid that is a precursor of MELANIN; DOPAMINE; noradrenalin (NOREPINEPHRINE), and THYROXINE.
  • SUS SCROFA BONE 30 [hp_X]/30mL
  • SUS SCROFA PARATHYROID GLAND 30 [hp_X]/30mL
  • THREONINE 3 [hp_X]/30mL - 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 3 [hp_X]/30mL - 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.
  • VALINE 3 [hp_X]/30mL - 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:

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".