| Drug NDC: | 64578-0102 |
| 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: | Metabopath |
| 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: | Adenosinum Cyclophosphoricum, Adenosinum Triphosphoricum Dinatrum, Alpha-ketoglutaricum Acidum, Berberis Vulgaris, Citricum Acidum, Coenzyme A, Dna, Fumaricum Acidum, Glycyrrhiza Glabra, Hepar Sulphuris Calcareum, Lappa Major, Magnesia Phosphorica, Manganum Aceticum, Nadidum, Natrum Muriaticum, Natrum Oxalaceticum, Natrum Pyruvicum, Nicotinamidum, Pulsatilla, Pyridoxinum Hydrochloricum, Rhamnus Purshiana, Riboflavinum, Rna, Silicea, Succinicum Acidum, Sulphur, Thiaminum Hydrochloricum, |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Energetix Corp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Liquid |
| 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 - 12 [hp_X]/mL ADENOSINE CYCLIC PHOSPHATE - 8 [hp_X]/mL ADENOSINE TRIPHOSPHATE DISODIUM - 12 [hp_X]/mL ANHYDROUS CITRIC ACID - 8 [hp_X]/mL ARCTIUM LAPPA ROOT - 4 [hp_X]/mL BERBERIS VULGARIS ROOT BARK - 4 [hp_X]/mL CALCIUM SULFIDE - 30 [hp_X]/mL COENZYME A - 12 [hp_X]/mL FRANGULA PURSHIANA BARK - 4 [hp_X]/mL FUMARIC ACID - 12 [hp_X]/mL Load more... GLYCYRRHIZA GLABRA - 4 [hp_X]/mL HERRING SPERM DNA - 30 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC - 12 [hp_X]/mL MANGANESE ACETATE TETRAHYDRATE - 10 [hp_X]/mL NADIDE - 12 [hp_X]/mL NIACINAMIDE - 6 [hp_X]/mL PULSATILLA VULGARIS - 12 [hp_X]/mL PYRIDOXINE HYDROCHLORIDE - 6 [hp_X]/mL RIBOFLAVIN - 10 [hp_X]/mL SACCHAROMYCES CEREVISIAE RNA - 30 [hp_X]/mL SILICON DIOXIDE - 12 [hp_X]/mL SODIUM CHLORIDE - 12 [hp_X]/mL SODIUM DIETHYL OXALACETATE - 12 [hp_X]/mL SODIUM PYRUVATE - 12 [hp_X]/mL SUCCINIC ACID - 12 [hp_X]/mL SULFUR - 12 [hp_X]/mL THIAMINE HYDROCHLORIDE - 6 [hp_X]/mL THYROID, BOVINE - 9 [hp_X]/mL TRIFOLIUM PRATENSE FLOWER - 4 [hp_X]/mL ZANTHOXYLUM AMERICANUM BARK - 4 [hp_X]/mL ZINC GLUCONATE - 10 [hp_X]/mL |
| 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: | 08 Aug, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 25 Dec, 2025 |
| 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: | Energetix Corp |
| 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. | |
| NUI: | N0000175833 N0000175835 N0000175980 N0000008556 N0000175089 N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0006342 M0016962 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 8ID597Z82X E0399OZS9N 5L51B4DR1G XF417D3PSL 597E9BI3Z3 1TH8Q20J0U 1MBW07J51Q SAA04E81UX 4VBP01X99F 88XHZ13131 Load more... 2788Z9758H 51FI676N6F A1Y870209Z 9TO51D176N 0U46U6E8UK 25X51I8RD4 I76KB35JEV 68Y4CF58BV TLM2976OFR J17GBZ5VGX ETJ7Z6XBU4 451W47IQ8X 6CA025Y4FG POD38AIF08 AB6MNQ6J6L 70FD1KFU70 M572600E5P MN18OTN73W 4JS0838828 A4KL1HMZ7T U6WSN5SQ1Z |
| 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 MOA: | Acidifying Activity [MoA] Calcium Chelating Activity [MoA] |
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. | |
| Pharmacologic Class EPC: | Calculi Dissolution Agent [EPC] Anti-coagulant [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant 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: | Decreased Coagulation Factor Activity [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: | Allergens [CS] Dietary Proteins [CS] Plant 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: | Acidifying Activity [MoA] Allergens [CS] Analogs/Derivatives [Chemical/Ingredient] Anti-coagulant [EPC] Calcium Chelating Activity [MoA] Calculi Dissolution Agent [EPC] Cell-mediated Immunity [PE] Copper Absorption Inhibitor [EPC] Decreased Coagulation Factor Activity [PE] Decreased Copper Ion Absorption [PE] Dietary Proteins [CS] Increased Histamine Release [PE] Magnetic Resonance Contrast Activity [MoA] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Paramagnetic Contrast Agent [EPC] Plant Proteins [CS] Vitamin B 6 [Chemical/Ingredient] Vitamin B6 Analog [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 |
|---|---|---|---|---|
| 64578-0102-1 | 59.1 mL in 1 BOTTLE, DROPPER (64578-0102-1) | 09 May, 2016 | 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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