| Drug NDC: | 64578-0075 |
| 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: | Rena-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: | AGATHOSMA BETULINA LEAF - 6 [hp_X]/59.1mL ALUMINUM OXIDE - 15 [hp_X]/59.1mL ANTIMONY - 15 [hp_X]/59.1mL APIS MELLIFERA - 12 [hp_X]/59.1mL ARCTOSTAPHYLOS UVA-URSI LEAF - 5 [hp_X]/59.1mL ARSENIC - 15 [hp_X]/59.1mL BERBERIS VULGARIS ROOT BARK - 4 [hp_X]/59.1mL BRYONIA ALBA ROOT - 12 [hp_X]/59.1mL CADMIUM - 15 [hp_X]/59.1mL COBALT - 15 [hp_X]/59.1mL Load more... COPPER - 15 [hp_X]/59.1mL ECHINACEA ANGUSTIFOLIA - 4 [hp_X]/59.1mL ELYMUS REPENS ROOT - 4 [hp_X]/59.1mL EUTROCHIUM PURPUREUM ROOT - 6 [hp_X]/59.1mL IRON - 15 [hp_X]/59.1mL KEROSENE - 15 [hp_X]/59.1mL LEAD - 15 [hp_X]/59.1mL LITHIUM CARBONATE - 15 [hp_X]/59.1mL LYTTA VESICATORIA - 8 [hp_X]/59.1mL MERCURIC CHLORIDE - 15 [hp_X]/59.1mL PLATINUM - 15 [hp_X]/59.1mL PULSATILLA VULGARIS - 12 [hp_X]/59.1mL SARSAPARILLA - 5 [hp_X]/59.1mL SAW PALMETTO - 8 [hp_X]/59.1mL SOLIDAGO VIRGAUREA FLOWERING TOP - 6 [hp_X]/59.1mL TARAXACUM OFFICINALE - 4 [hp_X]/59.1mL THUJA OCCIDENTALIS LEAFY TWIG - 12 [hp_X]/59.1mL TITANIUM - 15 [hp_X]/59.1mL VANADIUM - 15 [hp_X]/59.1mL ZINC - 15 [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: | 28 Apr, 2016 |
| 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: | N0000185021 N0000175629 N0000184306 N0000185001 M0000728 M0002274 N0000185508 M0005152 N0000175831 N0000008595 N0000008924 N0000175830 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 369DDH39Z0 LMI26O6933 9IT35J3UV3 7S82P3R43Z 3M5V3D1X36 N712M78A8G 1TH8Q20J0U T7J046YI2B 00BH33GNGH 3G0H8C9362 Load more... 789U1901C5 VB06AV5US8 3IXW0F6P8W 0VYG5PVN5Q E1UOL152H7 1C89KKC04E 2P299V784P 2BMD2GNA4V 3Q034RO3BT 53GH7MZT1R 49DFR088MY I76KB35JEV 2H1576D5WG J7WWH9M8QS 5405K23S50 39981FM375 1NT28V9397 D1JT611TNE 00J9J9XKDE J41CSQ7QDS |
| 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 EPC: | Standardized Insect Venom Allergenic Extract [EPC] Standardized Chemical Allergen [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: | Increased Histamine Release [PE] Cell-mediated Immunity [PE] Increased IgG Production [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] Bee Venoms [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: | Allergens [CS] Bee Venoms [CS] Cell-mediated Immunity [PE] Copper [CS] Copper-containing Intrauterine Device [EPC] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Increased Histamine Release [PE] Increased IgG Production [PE] Inhibit Ovum Fertilization [PE] Mood Stabilizer [EPC] Standardized Chemical Allergen [EPC] Standardized Insect Venom Allergenic Extract [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 |
|---|---|---|---|---|
| 64578-0075-1 | 59.1 mL in 1 BOTTLE, DROPPER (64578-0075-1) | 28 Apr, 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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