| Drug NDC: | 64578-0109 |
| 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: | Isopathic Phenolic Rings |
| 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: | Homeopathic Liquid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Energetix Corporation |
| 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: | ACETALDEHYDE - 12 [hp_X]/59.1mL ANHYDROUS CITRIC ACID - 12 [hp_X]/59.1mL ARABICA COFFEE BEAN - 12 [hp_X]/59.1mL BENZENE - 12 [hp_X]/59.1mL BOS TAURUS HYPOTHALAMUS - 12 [hp_X]/59.1mL BOS TAURUS TESTICLE - 12 [hp_X]/59.1mL CAFFEINE - 12 [hp_X]/59.1mL CANDIDA ALBICANS - 12 [hp_X]/59.1mL CHOLINE - 12 [hp_X]/59.1mL CINNAMON - 12 [hp_X]/59.1mL Load more... COCOA - 12 [hp_X]/59.1mL COUMARIN - 12 [hp_X]/59.1mL ESTRONE - 12 [hp_X]/59.1mL GALLIC ACID - 12 [hp_X]/59.1mL GREEN PEPPERCORN - 12 [hp_X]/59.1mL HISTAMINE - 12 [hp_X]/59.1mL INDOLE - 12 [hp_X]/59.1mL KEROSENE - 12 [hp_X]/59.1mL ONION - 12 [hp_X]/59.1mL PETROSELINUM CRISPUM - 12 [hp_X]/59.1mL PHENOL - 12 [hp_X]/59.1mL PHLORIZIN - 12 [hp_X]/59.1mL PHOSPHORUS - 12 [hp_X]/59.1mL SUCROSE - 12 [hp_X]/59.1mL SUS SCROFA ADRENAL GLAND - 9 [hp_X]/59.1mL TURPENTINE OIL - 12 [hp_X]/59.1mL VALERIAN - 12 [hp_X]/59.1mL |
| 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: | 03 Nov, 2017 |
| 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 Corporation |
| 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. | |
| UPC: | 0364578070118 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000175833 N0000175835 N0000175980 N0000008556 N0000175089 N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0516536 N0000175739 N0000175729 N0000175790 M0023046 N0000185372 N0000185001 M0008890 M0008672 M0022575 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | GO1N1ZPR3B XF417D3PSL 3SW678MX72 J64922108F S6G2NLH4Y7 PR4RXL6G2H 3G6A5W338E 4D7G21HDBC N91BDP6H0X 5S29HWU6QB Load more... D9108TZ9KG A4VZ22K1WT 2DI9HA706A 632XD903SP 6G53L8ESRK 820484N8I3 8724FJW4M5 1C89KKC04E 492225Q21H 1WZA4Y92EX 339NCG44TV CU9S17279X 27YLU75U4W C151H8M554 398IYQ16YV C5H0QJ6V7F JWF5YAW3QW |
| 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] Central Nervous System Stimulant [EPC] Methylxanthine [EPC] Non-Standardized Fungal 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] Central Nervous System Stimulation [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] Dietary Proteins [CS] Plant Proteins [CS] Seed Storage Proteins [CS] Xanthines [CS] Fungal Proteins [CS] Food Additives [CS] Vegetable 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] Anti-coagulant [EPC] Calcium Chelating Activity [MoA] Calculi Dissolution Agent [EPC] Cell-mediated Immunity [PE] Central Nervous System Stimulant [EPC] Central Nervous System Stimulation [PE] Decreased Coagulation Factor Activity [PE] Dietary Proteins [CS] Food Additives [CS] Fungal Proteins [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Methylxanthine [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Fungal Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Seed Storage Proteins [CS] Vegetable Proteins [CS] Xanthines [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 |
|---|---|---|---|---|
| 64578-0109-1 | 59.1 mL in 1 BOTTLE, DROPPER (64578-0109-1) | 03 Nov, 2017 | 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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