| Drug NDC: | 44911-0451 |
| 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: | Recovatone |
| 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: | Glycyrrhiza Glabra, Kali Muriaticum, Zincum Gluconicum, Kali Phosphoricum, Iodium, Phosphorus, Adrenocorticotrophin, Ascorbicum Acidum, Calcium Gluconate, L-arginine, L-carnitine, L-ornithine, Magnesia Muriatica, Magnesium Gluconicum, Dihydricum, Manganese Gluconate, Natrum Muriaticum, Adrenalinum, Cobalt Gluconate, Copper Gluconate, Creatine, Ferrous Gluconate, Glutamine, L-leucine, L-valine, Potassium Gluconate, Selenium Dioxide, Boron, Calcarea Phosphorica, Chromium, Molybdenum, Niccolum Metallicum |
| 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: | ARGININE - 6 [hp_X]/mL ASCORBIC ACID - 6 [hp_X]/mL BORON - 12 [hp_X]/mL CALCIUM GLUCONATE - 6 [hp_X]/mL CARNITINE - 6 [hp_X]/mL CHROMIUM - 14 [hp_X]/mL COBALTOUS GLUCONATE - 8 [hp_X]/mL COPPER GLUCONATE - 8 [hp_X]/mL CORTICOTROPIN - 6 [hp_X]/mL CREATINE - 8 [hp_X]/mL Load more... DIBASIC POTASSIUM PHOSPHATE - 3 [hp_X]/mL EPINEPHRINE - 8 [hp_X]/mL FERROUS GLUCONATE - 10 [hp_X]/mL GLUTAMINE - 8 [hp_X]/mL GLYCYRRHIZA GLABRA - 1 [hp_X]/mL IODINE - 4 [hp_X]/mL LEUCINE - 8 [hp_X]/mL MAGNESIUM CHLORIDE - 6 [hp_X]/mL MAGNESIUM GLUCONATE - 6 [hp_X]/mL MANGANESE GLUCONATE - 6 [hp_X]/mL MOLYBDENUM - 12 [hp_X]/mL NICKEL - 12 [hp_X]/mL ORNITHINE - 6 [hp_X]/mL PHOSPHORUS - 5 [hp_X]/mL POTASSIUM CHLORIDE - 2 [hp_X]/mL POTASSIUM GLUCONATE - 8 [hp_X]/mL SELENIUM - 12 [hp_X]/mL SELENIUM DIOXIDE - 8 [hp_X]/mL SODIUM CHLORIDE - 6 [hp_X]/mL STRONTIUM CARBONATE - 12 [hp_X]/mL TRIBASIC CALCIUM PHOSPHATE - 12 [hp_X]/mL VALINE - 8 [hp_X]/mL VANADIUM - 12 [hp_X]/mL ZINC GLUCONATE - 4 [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: | 02 Apr, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 17 Sep, 2024 |
| 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: | 09 May, 2026 |
| 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: | N0000193618 M0001797 N0000185508 N0000175629 N0000184306 M0000728 M0000499 N0000175941 N0000000209 N0000000245 N0000175552 N0000175555 N0000175570 M0003647 N0000175780 M0000922 N0000185371 N0000185375 M0006342 M0016962 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 94ZLA3W45F PQ6CK8PD0R N9E3X5056Q SQE6VB453K S7UI8SM58A 0R0008Q3JB 26SK597UWV RV823G6G67 K0U68Q2TXA MU72812GK0 Load more... CI71S98N1Z YKH834O4BH U1B11I423Z 0RH81L854J 2788Z9758H 9679TC07X4 GMW67QNF9C 02F3473H9O T42NAD2KHC 9YY2F980SV 81AH48963U 7OV03QG267 E524N2IXA3 27YLU75U4W 660YQ98I10 12H3K5QKN9 H6241UJ22B 9N3UK29E57 451W47IQ8X 41YPU4MMCA 91D9GV0Z28 HG18B9YRS7 00J9J9XKDE 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: | Adrenergic alpha-Agonists [MoA] Adrenergic beta-Agonists [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: | Vitamin C [EPC] Standardized Chemical Allergen [EPC] Adrenocorticotropic Hormone [EPC] alpha-Adrenergic Agonist [EPC] beta-Adrenergic Agonist [EPC] Catecholamine [EPC] Amino Acid [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] |
| 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] Adrenocorticotropic Hormone [CS] Catecholamines [CS] Amino Acids [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: | Adrenergic alpha-Agonists [MoA] Adrenergic beta-Agonists [MoA] Adrenocorticotropic Hormone [CS] Adrenocorticotropic Hormone [EPC] Allergens [CS] Amino Acid [EPC] Amino Acids [CS] Ascorbic Acid [CS] Blood Coagulation Factor [EPC] Calcium [CS] Calculi Dissolution Agent [EPC] Catecholamine [EPC] Catecholamines [CS] Cations Divalent [CS] Cell-mediated Immunity [PE] Copper Absorption Inhibitor [EPC] Decreased Copper Ion Absorption [PE] Dietary Proteins [CS] Increased Coagulation Factor Activity [PE] Increased Histamine Release [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Magnetic Resonance Contrast Activity [MoA] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Osmotic Activity [MoA] Osmotic Laxative [EPC] Paramagnetic Contrast Agent [EPC] Plant Proteins [CS] Potassium Compounds [CS] Potassium Salt [EPC] Standardized Chemical Allergen [EPC] Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] Vitamin C [EPC] alpha-Adrenergic Agonist [EPC] beta-Adrenergic Agonist [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 |
|---|---|---|---|---|
| 44911-0451-1 | 120 mL in 1 BOTTLE, DROPPER (44911-0451-1) | 02 Apr, 2018 | 17 Sep, 2024 | 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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