| Drug NDC: | 17089-075 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. | |
| Proprietary Name: | Omeosport |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. | |
| Non Proprietary 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 - |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Guna Spa |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Pellet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. | |
| Substance Name: | .ALPHA.-KETOGLUTARIC ACID - 6 [hp_X]/4g .ALPHA.-LIPOIC ACID - 6 [hp_X]/4g ACONITIC ACID, (Z)- - 6 [hp_X]/4g ADENOSINE TRIPHOSPHATE - 8 [hp_X]/4g ASCORBIC ACID - 4 [hp_X]/4g ASIAN GINSENG - 3 [hp_X]/4g BARIUM OXALOSUCCINATE - 6 [hp_X]/4g BEET - 2 [hp_X]/4g CEROUS OXALATE NONAHYDRATE - 6 [hp_X]/4g COENZYME A - 6 [hp_X]/4g Load more... CYSTEINE - 6 [hp_X]/4g FUMARIC ACID - 6 [hp_X]/4g LACTIC ACID - 8 [hp_X]/4g MAGNESIUM CARBONATE - 2 [hp_X]/4g MALIC ACID - 6 [hp_X]/4g MANGANESE PHOSPHATE, DIBASIC - 6 [hp_X]/4g PORK - 6 [hp_X]/4g PYRIDOXINE HYDROCHLORIDE - 6 [hp_X]/4g RIBOFLAVIN - 6 [hp_X]/4g SODIUM DIETHYL OXALACETATE - 6 [hp_X]/4g SODIUM PYRUVATE - 6 [hp_X]/4g SUCCINIC ACID - 6 [hp_X]/4g SUS SCROFA ADRENAL GLAND - 10 [hp_X]/4g SUS SCROFA EMBRYO - 6 [hp_X]/4g THIAMINE HYDROCHLORIDE - 4 [hp_X]/4g |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | ORAL |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. | |
| Marketing Start Date: | 23 May, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 12 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. | |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Guna spa |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. | |
| Original Packager: | Yes |
| Whether or not the drug has been repackaged for distribution. | |
| UPC: | 0317089075202 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000193618 M0001797 N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0022575 N0000185017 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 8ID597Z82X 73Y7P0K73Y OF5471ZHRR 8L70Q75FXE PQ6CK8PD0R CUQ3A77YXI L7A49804ZQ N487KM8COK 0UV74P3R0J SAA04E81UX Load more... K848JZ4886 88XHZ13131 33X04XA5AT 0E53J927NA 817L1N4CKP VZ3U1H7Q5B O138UB266J 68Y4CF58BV TLM2976OFR 6CA025Y4FG POD38AIF08 AB6MNQ6J6L 398IYQ16YV 9928MC12VO M572600E5P |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. | |
| Pharmacologic Class EPC: | Vitamin C [EPC] Non-Standardized Plant Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] |
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. | |
| Pharmacologic Class PE: | Increased Histamine Release [PE] Cell-mediated Immunity [PE] |
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. | |
| Pharmacologic Class CS: | Ascorbic Acid [CS] Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Vegetable Proteins [CS] |
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. | |
| Pharmacologic Class: | Allergens [CS] Analogs/Derivatives [Chemical/Ingredient] Ascorbic Acid [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Increased Histamine Release [PE] Magnetic Resonance Contrast Activity [MoA] Meat Proteins [EXT] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Paramagnetic Contrast Agent [EPC] Plant Proteins [CS] Vegetable Proteins [CS] Vitamin B 6 [Chemical/Ingredient] Vitamin B6 Analog [EPC] Vitamin C [EPC] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 17089-075-20 | 2 TUBE in 1 BOX (17089-075-20) / 4 g in 1 TUBE | 21 Dec, 2018 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. | ||||
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