| Drug NDC: | 64578-0064 |
| 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: | Hepata-chord |
| 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 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: | ACETIC ACID - 18 [hp_X]/59.1mL ALUMINUM OXIDE - 18 [hp_X]/59.1mL ARCTIUM LAPPA ROOT - 4 [hp_X]/59.1mL ASPIRIN - 18 [hp_X]/59.1mL BENZENE - 12 [hp_X]/59.1mL BERBERIS VULGARIS ROOT BARK - 4 [hp_X]/59.1mL BOS TAURUS HYPOTHALAMUS - 12 [hp_X]/59.1mL CENTELLA ASIATICA - 5 [hp_X]/59.1mL CHELIDONIUM MAJUS - 4 [hp_X]/59.1mL CHELONE GLABRA - 12 [hp_X]/59.1mL Load more... CHLORAMPHENICOL - 18 [hp_X]/59.1mL CHLORPROMAZINE - 18 [hp_X]/59.1mL CHOLESTEROL - 12 [hp_X]/59.1mL CORTISONE ACETATE - 18 [hp_X]/59.1mL ESTRONE - 18 [hp_X]/59.1mL GAMBOGE - 12 [hp_X]/59.1mL KEROSENE - 18 [hp_X]/59.1mL MILK THISTLE - 4 [hp_X]/59.1mL PARAFFIN - 18 [hp_X]/59.1mL PHENACETIN - 18 [hp_X]/59.1mL PHOSPHORUS - 12 [hp_X]/59.1mL PORK LIVER - 9 [hp_X]/59.1mL SILICON DIOXIDE - 12 [hp_X]/59.1mL SODIUM SULFATE - 12 [hp_X]/59.1mL TARAXACUM OFFICINALE - 4 [hp_X]/59.1mL THYROID, UNSPECIFIED - 9 [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: | 17 Nov, 2014 |
| 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 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: | N0000000160 N0000008836 M0001335 N0000175722 N0000175578 N0000008832 N0000175480 N0000175479 N0000175746 M0016525 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | Q40Q9N063P LMI26O6933 597E9BI3Z3 R16CO5Y76E J64922108F 1TH8Q20J0U S6G2NLH4Y7 7M867G6T1U 7E889U5RNN 6G3UN932VF Load more... 66974FR9Q1 U42B7VYA4P 97C5T2UQ7J 883WKN7W8X 2DI9HA706A 7556HJ7587 1C89KKC04E U946SH95EE I9O0E3H2ZE ER0CTH01H9 27YLU75U4W 6EC706HI7F ETJ7Z6XBU4 0YPR65R21J 39981FM375 0B4FDL9I6P |
| 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: | Cyclooxygenase Inhibitors [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: | Nonsteroidal Anti-inflammatory Drug [EPC] Platelet Aggregation Inhibitor [EPC] Amphenicol-class Antibacterial [EPC] Phenothiazine [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 Prostaglandin Production [PE] Decreased Platelet Aggregation [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: | Anti-Inflammatory Agents, Non-Steroidal [CS] Phenothiazines [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: | Amphenicol-class Antibacterial [EPC] Amphenicols [EXT] Anti-Inflammatory Agents Non-Steroidal [CS] Corticosteroid Hormone Receptor Agonists [MoA] Corticosteroid [EPC] Cyclooxygenase Inhibitors [MoA] Decreased Platelet Aggregation [PE] Decreased Prostaglandin Production [PE] Nonsteroidal Anti-inflammatory Drug [EPC] Phenothiazine [EPC] Phenothiazines [CS] Platelet Aggregation Inhibitor [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 |
|---|---|---|---|---|
| 64578-0064-1 | 59.1 mL in 1 BOTTLE, DROPPER (64578-0064-1) | 01 Jun, 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. | ||||
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