| Drug NDC: | 44911-0650 |
| 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: | Metalstat |
| 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: | Allium Sativum, Avena Sativa, Berberis Vulgaris, Lappa Major, Solidago Virgaurea, Phytolacca Decandra, Lycopodium Clavatum, Nux Vomica, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum, Molybdenum, |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Energique, Inc. |
| 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: | ALUMINUM - 12 [hp_X]/mL ANTIMONY TRISULFIDE - 12 [hp_X]/mL ARCTIUM LAPPA ROOT - 3 [hp_X]/mL ARSENIC TRIOXIDE - 12 [hp_X]/mL AVENA SATIVA FLOWERING TOP - 3 [hp_X]/mL BARIUM CARBONATE - 12 [hp_X]/mL BERBERIS VULGARIS ROOT BARK - 3 [hp_X]/mL BERYLLIUM - 12 [hp_X]/mL BISMUTH - 12 [hp_X]/mL BORON - 12 [hp_X]/mL Load more... BROMINE - 12 [hp_X]/mL CADMIUM - 12 [hp_X]/mL CERIUM - 12 [hp_X]/mL CESIUM CHLORIDE - 12 [hp_X]/mL CHROMIUM - 12 [hp_X]/mL COBALT - 12 [hp_X]/mL COPPER - 12 [hp_X]/mL DYSPROSIUM - 12 [hp_X]/mL ERBIUM - 12 [hp_X]/mL EUROPIUM OXIDE - 12 [hp_X]/mL GADOLINIUM OXIDE - 12 [hp_X]/mL GARLIC - 3 [hp_X]/mL GERMANIUM SESQUIOXIDE - 12 [hp_X]/mL GOLD - 12 [hp_X]/mL HOLMIUM - 12 [hp_X]/mL INDIUM - 12 [hp_X]/mL IRON - 12 [hp_X]/mL LANTHANUM - 14 [hp_C]/mL LEAD - 12 [hp_X]/mL LITHIUM CARBONATE - 12 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 12 [hp_X]/mL MAGNESIUM - 12 [hp_X]/mL MANGANESE - 12 [hp_X]/mL MERCURIUS SOLUBILIS - 12 [hp_X]/mL MOLYBDENUM - 12 [hp_X]/mL NEODYMIUM OXIDE - 12 [hp_X]/mL NICKEL - 12 [hp_X]/mL NIOBIUM - 30 [hp_C]/mL OSMIUM - 12 [hp_X]/mL PALLADIUM - 12 [hp_X]/mL PHYTOLACCA AMERICANA ROOT - 4 [hp_X]/mL PLATINUM - 12 [hp_X]/mL PRASEODYMIUM - 12 [hp_X]/mL RHODIUM - 12 [hp_X]/mL RUBIDIUM NITRITE - 12 [hp_X]/mL SAMARIUM OXIDE - 12 [hp_X]/mL SELENIUM - 12 [hp_X]/mL SILVER - 12 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP - 3 [hp_X]/mL STRONTIUM CARBONATE - 12 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED - 12 [hp_X]/mL TANTALUM - 30 [hp_C]/mL TERBIUM - 12 [hp_X]/mL THALLIUM - 12 [hp_X]/mL TIN - 12 [hp_X]/mL URANYL NITRATE HEXAHYDRATE - 12 [hp_X]/mL VANADIUM - 12 [hp_X]/mL YTTERBIUM OXIDE - 12 [hp_X]/mL ZINC - 12 [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: | 11 Feb, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 23 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: | Energique, Inc. |
| 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: | N0000185508 N0000175629 N0000184306 M0000728 M0005152 N0000175831 N0000008595 N0000008924 N0000175830 N0000185371 M0006342 M0016962 N0000185375 N0000185001 M0516536 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | CPD4NFA903 F79059A38U 597E9BI3Z3 S7V92P67HO MA9CQJ3F7F 6P669D8HQ8 1TH8Q20J0U OW5102UV6N U015TT5I8H N9E3X5056Q Load more... SBV4XY874G 00BH33GNGH 30K4522N6T GNR9HML8BA 0R0008Q3JB 3G0H8C9362 789U1901C5 1D4N45714Q 77B218D3YE 44642614WR 5480D0NHLJ V1V998DC17 96WE91N25T 79Y1949PYO W1XX32SQN1 045A6V3VFX E1UOL152H7 6I3K30563S 2P299V784P 2BMD2GNA4V C88X29Y479 I38ZP9992A 42Z2K6ZL8P 324Y4038G2 81AH48963U AYT3H319PN 7OV03QG267 05175J654G 2E7M255OPY 5TWQ1V240M 11E6VI8VEG 49DFR088MY NKN7EZA750 DMK383DSAC 93722E7JA1 91N8739X2N H6241UJ22B 3M4G523W1G 5405K23S50 41YPU4MMCA 269XH13919 6424HBN274 06SSF7P179 AD84R52XLF 387GMG9FH5 3V057702FY 00J9J9XKDE T66CZ53RP4 J41CSQ7QDS |
| 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: | Standardized Chemical Allergen [EPC] Copper-containing Intrauterine Device [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: | Increased Histamine Release [PE] Cell-mediated Immunity [PE] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Inhibit Ovum Fertilization [PE] Increased IgG Production [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] Copper [CS] Dietary Proteins [CS] Plant Proteins [CS] Seed Storage 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] Cell-mediated Immunity [PE] Copper [CS] Copper-containing Intrauterine Device [EPC] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Dietary Proteins [CS] Gadolinium-based Contrast Agent [EPC] Increased Histamine Release [PE] Increased IgG Production [PE] Inhibit Ovum Fertilization [PE] Magnetic Resonance Contrast Activity [MoA] Mood Stabilizer [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Seed Storage Proteins [CS] Standardized Chemical Allergen [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 |
|---|---|---|---|---|
| 44911-0650-1 | 60 mL in 1 BOTTLE, DROPPER (44911-0650-1) | 11 Feb, 2022 | 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. | ||||
* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.