| Drug NDC: | 69780-0003 |
| 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: | Energy Complex |
| 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: | Echinacea (angustifolia), Lappa Major, Solidago Virgaurea, Taraxacum Officinale, Adrenalinum, Aloe, Arsenicum Album, Baptisia Tinctoria, Berberis Aquifolium, Berberis Vulgaris, Bryonia (alba), Chelidonium Majus, Crotalus Horridus, Digitalis Purpurea, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra, Hydrocotyle Asiatica, Iodium, Iris Versicolor, Lachesis Mutus, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Ruta Graveolens, Thuja Occidentalis, Thyroidinum (bovine) |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | True Weight Loss Solutions |
| 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: | ALOE - 15 [hp_X]/mL ARCTIUM LAPPA ROOT - 3 [hp_X]/mL ARSENIC TRIOXIDE - 15 [hp_X]/mL BAPTISIA TINCTORIA ROOT - 15 [hp_X]/mL BERBERIS VULGARIS ROOT BARK - 15 [hp_X]/mL BRYONIA ALBA ROOT - 15 [hp_X]/mL CENTELLA ASIATICA - 15 [hp_X]/mL CHELIDONIUM MAJUS - 15 [hp_X]/mL CROTALUS HORRIDUS HORRIDUS VENOM - 15 [hp_X]/mL DIGITALIS - 15 [hp_X]/mL Load more... ECHINACEA ANGUSTIFOLIA - 3 [hp_X]/mL EPINEPHRINE - 15 [hp_X]/mL GLYCYRRHIZA GLABRA - 15 [hp_X]/mL IODINE - 15 [hp_X]/mL IRIS VERSICOLOR ROOT - 15 [hp_X]/mL IRON - 15 [hp_X]/mL LACHESIS MUTA VENOM - 15 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 15 [hp_X]/mL MAHONIA AQUIFOLIUM ROOT BARK - 15 [hp_X]/mL NITROGLYCERIN - 15 [hp_X]/mL RUTA GRAVEOLENS FLOWERING TOP - 15 [hp_X]/mL SODIUM CHLORIDE - 15 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP - 3 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED - 15 [hp_X]/mL TARAXACUM OFFICINALE - 3 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG - 15 [hp_X]/mL THYROID, BOVINE - 15 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF - 15 [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: | 29 Feb, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 06 Aug, 2023 |
| 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: | 18 Jun, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | True Weight Loss Solutions |
| 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: | N0000000209 N0000000245 N0000175552 N0000175555 N0000175570 M0003647 N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0006342 M0016962 N0000175415 M0014874 N0000009909 N0000185001 M0516536 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | V5VD430YW9 597E9BI3Z3 S7V92P67HO 5EF0HWI5WU 1TH8Q20J0U T7J046YI2B 7M867G6T1U 7E889U5RNN YHA2XLJ956 F1T8QT9U8B Load more... VB06AV5US8 YKH834O4BH 2788Z9758H 9679TC07X4 X43D4L3DQC E1UOL152H7 VSW71SS07I C88X29Y479 VZJ9F3C3SB G59M7S0WS3 N94C2U587S 451W47IQ8X 5405K23S50 269XH13919 39981FM375 1NT28V9397 MN18OTN73W 6IO182RP7A |
| 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: | alpha-Adrenergic Agonist [EPC] beta-Adrenergic Agonist [EPC] Catecholamine [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Nitrate Vasodilator [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] Vasodilation [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: | Catecholamines [CS] Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Nitrates [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: | Adrenergic alpha-Agonists [MoA] Adrenergic beta-Agonists [MoA] Allergens [CS] Catecholamine [EPC] Catecholamines [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Nitrate Vasodilator [EPC] Nitrates [CS] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Seed Storage Proteins [CS] Vasodilation [PE] 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 |
|---|---|---|---|---|
| 69780-0003-1 | 30 mL in 1 BOTTLE, DROPPER (69780-0003-1) | 29 Feb, 2016 | 06 Aug, 2023 | 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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