| Drug NDC: | 64578-0095 |
| 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: | Adaptopath |
| 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, Alpha-lipoicum Acidum, Argentum Metallicum, Avena Sativa, Capsicum Annuum, Citricum Acidum, Coenzyme A, Cuprum Metallicum, Ginkgo Biloba, Glandula Suprarenalis Suis, Glycyrrhiza Glabra, Hypothalamus (bovine), Iodium, Ledum Palustre, Manganum Aceticum, Nadidum, Natrum Carbonicum, Oleum Morrhuae, Phosphoricum Acidum, Picricum Acidum, Riboflavinum, Selenium Metallicum Sepia, Silicea, Thiaminum Hydrochloricum, Thyroidinum (bovine), Vanadium Metallicum |
| 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.-LIPOIC ACID - 12 [hp_X]/mL ADENOSINE CYCLIC PHOSPHATE - 8 [hp_X]/mL ANHYDROUS CITRIC ACID - 4 [hp_X]/mL AVENA SATIVA FLOWERING TOP - 4 [hp_X]/mL BOS TAURUS HYPOTHALAMUS - 12 [hp_X]/mL CAPSICUM - 4 [hp_X]/mL COD LIVER OIL - 6 [hp_X]/mL COENZYME A - 8 [hp_X]/mL COPPER - 12 [hp_X]/mL GINKGO - 4 [hp_X]/mL Load more... GLYCYRRHIZA GLABRA - 4 [hp_X]/mL IODINE - 12 [hp_X]/mL LEDUM PALUSTRE TWIG - 6 [hp_X]/mL MANGANESE ACETATE TETRAHYDRATE - 12 [hp_X]/mL NADIDE - 12 [hp_X]/mL PHOSPHORIC ACID - 12 [hp_X]/mL PICRIC ACID - 12 [hp_X]/mL RIBOFLAVIN - 12 [hp_X]/mL SELENIUM - 12 [hp_X]/mL SEPIA OFFICINALIS JUICE - 12 [hp_X]/mL SILICON DIOXIDE - 12 [hp_X]/mL SILVER - 12 [hp_X]/mL SODIUM CARBONATE - 12 [hp_X]/mL SUS SCROFA ADRENAL GLAND - 9 [hp_X]/mL THIAMINE HYDROCHLORIDE - 8 [hp_X]/mL THYROID, BOVINE - 9 [hp_X]/mL VANADIUM - 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: | 22 Oct, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 08 May, 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: | 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 N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0022575 M0005152 N0000175831 N0000008595 N0000008924 N0000175830 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 73Y7P0K73Y E0399OZS9N XF417D3PSL MA9CQJ3F7F S6G2NLH4Y7 00UK7646FG BBL281NWFG SAA04E81UX 789U1901C5 19FUJ2C58T Load more... 2788Z9758H 9679TC07X4 877L01IZ0P 9TO51D176N 0U46U6E8UK E4GA8884NN A49OS0F91S TLM2976OFR H6241UJ22B QDL83WN8C2 ETJ7Z6XBU4 3M4G523W1G 45P3261C7T 398IYQ16YV M572600E5P MN18OTN73W 00J9J9XKDE |
| 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 Plant Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] Copper-containing Intrauterine Device [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] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Inhibit Ovum Fertilization [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] Vegetable Proteins [CS] Copper [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] Anti-coagulant [EPC] Calcium Chelating Activity [MoA] Calculi Dissolution Agent [EPC] Cell-mediated Immunity [PE] Copper [CS] Copper-containing Intrauterine Device [EPC] Decreased Coagulation Factor Activity [PE] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Dietary Proteins [CS] Increased Histamine Release [PE] Inhibit Ovum Fertilization [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] Vegetable Proteins [CS] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 64578-0095-1 | 59.1 mL in 1 BOTTLE, DROPPER (64578-0095-1) | 23 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. | ||||
* 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.